Libmyris - patient leaflet, side effects, dosage

Patient leaflet - Libmyris

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Libmyris 40 mg solution for injection in pre-filled syringe

adalimumab

This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– Your doctor will also give you a Patient Reminder Card , which contains important safety information that you need to be aware of before you begin using Libmyris and during treatment with Libmyris. Keep this Patient Reminder Card with you during your treatment and for 4 months after your last injection of Libmyris.
- If you have any further questions, ask your doct or or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Libmyris is and what it is used for
2. What you need to know before you use Libmyris
3. How to use Libmyris
4. Possible side effects
5. How to store Libmyris
6. Contents of the pack and other information
7. Instructions for use

1. What Libmyris is and what it is used for

Libmyris contains the active substance adalimumab.

Libmyris is used to treat:

Rheumatoid arthritis
Polyarticular juvenile idiopathic arthritis
Enthesitis-related arthritis
Ankylosing spondylitis
Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Psoriatic arthritis
Plaque psoriasis
Hidradenitis suppurativa
Crohn’s disease
Ulcerative colitis
Non-infectious uveitis

he active substance in Libmyris, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.

The target of adalimumab is a protein called tumour necrosis factor (TNFa), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFa, Libmyris decreases the process of inflammation in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Libmyris is used to treat moderate to severe rheumatoid arthritis in adults. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Libmyris.

Libmyris can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Libmyris can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.

Your doctor will decide if Libmyris should be used with methotrexate or alone.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.

Libmyris is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Libmyris.

Your doctor will decide if Libmyris should be used with methotrexate or alone.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.

Libmyris is used to treat enthesitis-related arthritis in patients from 6 years of age. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Libmyris.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine.

Libmyris is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints that is usually associated with psoriasis.

Libmyris is used to treat psoriatic arthritis in adults. Libmyris can slow down the damage to the joints caused by the disease and can help them move more freely. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

Plaque psoriasis

Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.

Libmyris is used to treat

moderate to severe chronic plaque psoriasis in adults and
severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.

Hidradenitis suppurativa

Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

Libmyris is used to treat

moderate to severe hidradenitis suppurativa in adults and
moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years

Libmyris can reduce the number of nodules and abscesses caused by the disease and the pain that is often associated with the disease. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract.

Libmyris is used to treat

moderate to severe Crohn’s disease in adults and
moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine.

Libmyris is used to treat

moderate to severe ulcerative colitis in adults and
moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

Non-infectious uveitis

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

Libmyris is used to treat

adults with non-infectious uveitis with inflammation affecting the back of the eye
children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

2. What you need to know before you use Libmyris

Do not use Libmyris

If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
If you have active tuberculosis or other severe infections (see “Warnings and precautions”). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems.
If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Libmyris.

Allergic reactions

If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Libmyris and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.

Infections

If you have an infection, including long-term infection or an infection in one part of the body

(for example, leg ulcer) consult your doctor before starting Libmyris. If you are unsure, contact your doctor.

You might get infections more easily while you are receiving Libmyris treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include: o tuberculosis

o infections caused by viruses, fungi, parasites or bacteria

o severe infection in the blood (sepsis)

In rare cases, these infections can be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may tell you to stop using Libmyris for some time.

Tell your doctor if you live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.
If you are over 65 years you may be more likely to get infections while taking Libmyris. You and your doctor should pay special attention to signs of infection while you are being treated with Libmyris. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Tuberculosis

It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If you have active tuberculosis, do not use Libmyris.

o As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Libmyris. This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your Patient Reminder Card.

o Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.

o If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.

Hepatitis B

Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of getting HBV.

o Your doctor should test you for HBV. In people who carry HBV, adalimumab can cause the virus to become active again.

o In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

Surgery or dental procedures

If you are about to have surgery or dental procedures tell your doctor that you are taking Libmyris. Your doctor may recommend temporary discontinuation of Libmyris.

Demyelinating disease

If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Libmyris. Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.

Vaccinations

Certain vaccines may cause infections and should not be given while receiving Libmyris.

o Check with your doctor before you receive any vaccines.

o It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Libmyris.

o If you received Libmyris while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last Libmyris dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your Libmyris use during your pregnancy so they can decide when your baby should receive any vaccine.

Heart failure

If you have mild heart failure and are being treated with Libmyris, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if you should receive Libmyris.

Fever, bruising, bleeding or looking pale

In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. Your doctor may decide to stop treatment. If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away.

Cancer

There have been very rare cases of certain kinds of cancer in children and adult patients taking adalimumab or other TNF blockers.

o People with more serious rheumatoid arthritis who have had the disease for a long time

may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).

o If you take Libmyris the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma has been seen in patients taking adalimumab. Some of those patients were also treated with azathioprine or 6-mercaptopurine.

o Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Libmyris.

o Cases of non-melanoma skin cancer have been observed in patients taking adalimumab.

o If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

There have been cases of cancers, other than lymphoma, in patients with a specific type of lung

disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Autoimmune disease

On rare occasions, treatment with Libmyris could result in lupus-like syndrome. Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Children and adolescents

Vaccinations: if possible, children should be up to date with all vaccinations before using Libmyris.

Other medicines and Libmyris

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should not take Libmyris with medicines containing the following active substances due to increased risk of serious infection:

anakinra
abatacept.

Libmyris can be taken together with:

methotrexate
certain disease-modifying anti-rheumatic agents (for example, sulfasalazine,

hydroxychloroquine, leflunomide and injectable gold preparations)

steroids or pain medicine including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have questions, please ask your doctor.

Pregnancy and breast-feeding

You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Libmyris treatment.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
Libmyris should only be used during a pregnancy if needed.
According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Libmyris can be used during breast-feeding.
If you receive Libmyris during your pregnancy, your baby may have a higher risk for getting an infection.
It is important that you tell your baby’s doctors and other health care professionals about your Libmyris use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

Libmyris may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Libmyris.

Libmyris contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 0.4 ml, that is to say essentially ‘sodium-free’.

3. How to use Libmyris

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses for Libmyris in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Libmyris if you need a different dose.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Age or body weight

How much and how often to take?

Notes

Adults

40 mg every other week

In rheumatoid arthritis, methotrexate is continued while using Libmyris. If your doctor decides that methotrexate is inappropriate, Libmyris can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your Libmyris therapy, your doctor may decide to give Libmyris 40 mg every week or 80 mg every other week.

Polyarticular juvenile idiopathic arthritis
Age or body weight	How much and how often to take?	Notes
Children, adolescents and adults from 2 years of age weighing 30 kg or more	40 mg every other week	Not applicable

Enthesitis-related arthritis
Age or body weight	How much and how often to take?	Notes
Children, adolescents and adults from 6 years of age weighing 30 kg or more	40 mg every other week	Not applicable

Plaque psoriasis
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose.	If you have an inadequate response, your doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents from 4 to 17 years of age weighing 30 kg or more	First dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.	Not applicable

Hidradenitis suppurativa
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (two 40 mg injections in one day) two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.	It is recommended that you use an antiseptic wash daily on the affected areas.
Adolescents from 12 to 17 years of age weighing 30 kg or more	First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week later.	If you have an inadequate response to Libmyris 40 mg every other week, your doctor may increase the dose to 40 mg every week or 80 mg every other week. It is recommended that you use an antiseptic wash daily on the affected areas.

Crohn’s disease
Age or body weight	How much and how often to take?	Notes
Children, adolescents and adults from 6 years of age weighing 40 kg or more	First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later. If a faster response is required, the doctor may prescribe a first dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week.	Y our doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents from 6 to 17 years of age weighing less than 40 kg	First dose of 40 mg, followed by 20 mg two weeks later. If a faster response is required, the doctor may prescribe a first dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every other week.	Y our doctor may increase the dose frequency to 20 mg every week. *
Libmyris is only available as 4 syringe. Thus, it is not possible dose.	0 mg pre-filled syringe, 40 mg pre-filled pen and 80 mg pre-filled o administer Libmyris to patients that require less than a full 40 mg
Ulcerative colitis
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week.	Y our doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents from 6 years of age weighing less than 40 kg	First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg (one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.	Y ou should continue taking adalimumab at your usual dose, even after turning 18 years of age.

Children and adolescents from 6 years of age weighing 40 kg or more

First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 80 mg every other week.

Y ou should continue taking adalimumab at your usual dose, even after turning 18 years of age.

Non-infectious uveitis
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose.	Corticosteroids or other medicines that influence the immune system may be continued while using Libmyris. Libmyris can also be given alone.
Children and adolescents from 2 years of age weighing at least 30 kg	40 mg every other week	Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week. Libmyris is recommended for use in combination with methotrexate.

Method and route of administration

Libmyris is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Libmyris are provided in section 7, “Instructions for use”.

If you use more Libmyris than you should

If you accidentally inject Libmyris more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that you have taken more. Always take the outer carton of the medicine with you, even if it is empty.

If you forget to use Libmyris

If you forget to give yourself an injection, you should inject the next dose of Libmyris as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.

If you stop using Libmyris

The decision to stop using Libmyris should be discussed with your doctor. Your symptoms may return if you stop using Libmyris.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Libmyris injection.

Tell your doctor immediately if you notice any of the following

severe rash, hives or other signs of allergic reaction
swollen face, hands, feet
trouble breathing, swallowing
shortness of breath with physical activity or upon lying down or swelling of the feet

Tell your doctor as soon as possible , if you notice any of the following

signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
feeling weak or tired
coughing
tingling
numbness
double vision
arm or leg weakness
a bump or open sore that doesn't heal
signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness

The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people)

injection site reactions (including pain, swelling, redness or itching)
respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
headache
abdominal pain
nausea and vomiting
rash
musculoskeletal pain

Common (may affect up to 1 in 10 people)

serious infections (including blood poisoning and influenza)
intestinal infections (including gastroenteritis)
skin infections (including cellulitis and shingles)
ear infections
oral infections (including tooth infections and cold sores)
reproductive tract infections
urinary tract infection
fungal infections
joint infections
benign tumours
skin cancer
allergic reactions (including seasonal allergy)
dehydration
mood swings (including depression)
anxiety
difficulty sleeping
sensation disorders such as tingling, prickling or numbness
migraine
nerve root compression (including low back pain and leg pain)
vision disturbances
eye inflammation
inflammation of the eye lid and eye swelling
vertigo (feeling of dizziness or spinning)
sensation of heart beating rapidly
high blood pressure
flushing
haematoma (collection of blood outside of blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heart burn)
acid reflux disease
sicca syndrome (including dry eyes and dry mouth)
itching
itchy rash
bruising
inflammation of the skin (such as eczema)
breaking of finger nails and toe nails
increased sweating
hair loss
new onset or worsening of psoriasis
muscle spasms
blood in urine
kidney problems
chest pain
oedema (swelling)
fever
reduction in blood platelets which increases risk of bleeding or bruising
impaired healing

Uncommon (may affect up to 1 in 100 people)

opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
neurological infections (including viral meningitis)
eye infections
bacterial infections
diverticulitis (inflammation and infection of the large intestine)
cancer
cancer that affects the lymph system
melanoma
immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting

as sarcoidosis)

vasculitis (inflammation of blood vessels)
tremor (shaking)
neuropathy (disorder of the nerves)
stroke
hearing loss, buzzing
sensation of heart beating irregularly such as skipped beats
heart problems that can cause shortness of breath or ankle swelling
heart attack
a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel
lung diseases causing shortness of breath (including inflammation)
pulmonary embolism (blockage in an artery of the lung)
pleural effusion (abnormal collection of fluid in the pleural space)
inflammation of the pancreas which causes severe pain in the abdomen and back
difficulty in swallowing

facial oedema (swelling of the face)

gallbladder inflammation, gallbladder stones

fatty liver

night sweats

scar

abnormal muscle breakdown

systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)

sleep interruptions

impotence

inflammations

Rare (may affect up to 1 in 1,000 people)

leukaemia (cancer affecting the blood and bone marrow)
severe allergic reaction with shock
multiple sclerosis
nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
heart stops pumping
pulmonary fibrosis (scarring of the lung)
intestinal perforation (hole in the intestine)
hepatitis
reactivation of hepatitis B
autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
cutaneous vasculitis (inflammation of blood vessels in the skin)
Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
facial oedema (swelling of the face) associated with allergic reactions
erythema multiforme (inflammatory skin rash)
lupus-like syndrome
angioedema (localised swelling of the skin)
lichenoid skin reaction (itchy reddish-purple skin rash)

Not known (frequency cannot be estimated from the available data)

hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
Merkel cell carcinoma (a type of skin cancer)
Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
liver failure
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
weight gain (for most patients, the weight gain was small)

Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people) low blood measurements for white blood cells low blood measurements for red blood cells increased lipids in the blood
elevated liver enzymes

Common (may affect up to 1 in 10 people)

high blood measurements for white blood cells
low blood measurements for platelets
increased uric acid in the blood
abnormal blood measurements for sodium
low blood measurements for calcium
low blood measurements for phosphate
high blood sugar
high blood measurements for lactate dehydrogenase
autoantibodies present in the blood
low blood potassium

Uncommon (may affect up to 1 in 100 people)

elevated bilirubin measurement (liver blood test)

Rare (may affect up to 1 in 1,000 people)

low blood measurements for white blood cells, red blood cells and platelet count

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Libmyris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example when you are travelling), a single Libmyris pre-filled syringe may be stored at 20 °C to 25 °C for a maximum period of up to 14 days – be sure to protect it from light. Once removed from the refrigerator for storage at 20 °C to 25 °C, the syringe must be used within the 14 days or discarded , even if it is returned to the refrigerator.

You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.

Do not use this medicine if the liquid is cloudy, discoloured, or has flakes or particles in it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Libmyris contains

– The active substance is adalimumab
– The other ingredients are sodium chloride, sucrose, polysorbate 80, water for injections, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment)

What Libmyris looks like and contents of the pack

Libmyris 40 mg solution for injection in pre-filled syringe with needle guard is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml preservative-free solution.

The Libmyris pre-filled syringe is a glass syringe containing a solution of adalimumab.

Each pack contains 1, 2 or 6 pre-filled syringe(s) packed in a blister, with 1, 2 or 6 alcohol pad(s).

Not all pack sizes may be marketed.

Libmyris may be available as a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

STADA Arzneimittel AG

Stadastrasse 2–18

61118 Bad Vilbel

Germany

Manufacturer

Ivers-Lee CSM

Marie-Curie-Str.8

79539 Lörrach,

Germany

For any information about this medicine, please

Authorisation Holder:

Belgie/Belgique/Belgien

EG (Eurogenerics) NV

Tél/Tel: +32 24797878

Etnrapua

STADA Bulgaria EOOD

Ten.: +359 29624626

Česká republika

STADA PHARMA CZ s.r.o.

Tel: +420 257888111

Danmark

STADA Nordic ApS

Tlf: +45 44859999

Deutschland

STADAPHARM GmbH

Tel: +49 61016030

Eesti

UAB „STADA Baltics“

Tel: +370 52603926

EMáSa

STADA Arzneimittel AG

Tql: +30 2106664667

España

Laboratorio STADA, S.L.

Tel: +34 934738889

France

Biogaran SAS

Tél: +33 155724100

contact the local representative of the Marketing

Lietuva

UAB „STADA Baltics“

Tel: +370 52603926

Luxembourg/Luxemburg

EG (Eurogenerics) NV

Tel/Tel: +32 4797878

Magyarorszag

STADA Hungary Kft

Tel.: +36 18009747

Malta

Pharma.MT Ltd

Tel: +356 21337008

Nederland

Centrafarm B.V.

Tel.: +31 765081000

Norge

STADA Nordic ApS

Tlf: +45 44859999

Österreich

STADA Arzneimittel GmbH

Tel: +43 136785850

Polska

STADA Poland Sp. z.o o.

Tel: +48 227377920

Portugal

Stada, Lda.

Tel: +351 211209870

Hrvatska

STADA d.o.o.

Tel: +385 13764111

Romania

STADA M&D SRL

Tel: +40 213160640

Ireland

Clonmel Healthcare Ltd.

Tel: +353 526177777

Slovenija

Stada d.o.o.

Tel: +386 15896710

Ísland

STADA Arzneimittel AG

Sími: +49 61016030

Slovenská republika

STADA PHARMA Slovakia, s.r.o.

Tel: +421 252621933

Italia

EG SpA

Tel: +39 028310371

Suomi/Finland

STADA Nordic ApS, Suomen sivuliike

Puh/Tel: +358 207416888

Kùnpoç

STADA Arzneimittel AG

Tql: +30 2106664667

Sverige

STADA Nordic ApS

Tel: +45 44859999

Latvija

UAB „STADA Baltics“

Tel: +370 52603926

United Kingdom (Northern Ireland)

STADA Arzneimittel AG

Tel: +49 61016030

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

7. Instructions for use

INSTRUCTIONS FOR USE

Libmyris (adalimumab) pre-filled syringe

40 mg/0.4 ml solution for injection, for subcutaneous use

Read carefully these instructions for use before using the Libmyris single-use pre-filled syringe

Libmyris pre-filled syringe

Plunger

Important information you need to know before injecting Libmyris single-use pre-filled syringe

Important information:

For subcutaneous injection only
Do not use the syringe and call your healthcare provider or pharmacist if:
Liquid is cloudy, discoloured, or has flakes or particles in it
Expiry date has passed
Liquid has been frozen (even if thawed) or left in direct sunlight
The pre-filled syringe has been dropped or crushed
Keep the needle cover on until right before injection. Keep Libmyris out of reach of children.
See section 5 in the package leaflet for how to store Libmyris single-use pre-filled syringe.

Before injecting:

Your healthcare provider should show you how to use Libmyris single-use pre-filled syringe before you use it for the first time.

Current adalimumab syringe users:

Even if you have used other adalimumab syringes on the market in the past, please read the instructions completely so that you understand how to properly use this device before attempting to inject.

Questions about using the Libmyris pre-filled syringe?

Talk to your healthcare provider if you have any questions.

Preparing to inject Libmyris pre-filled syringe

STEP 1: Take syringe out of refrigerator and warm to 20 °C to 25 °C for 15–30 minutes

1.1 Take Libmyris out of the refrigerator (see Figure A).
1.2 Leave Libmyris at 20 °C to 25 °C for 15 to 30 minutes before injecting (see Figure B).

Do not remove the grey needle cover while allowing Libmyris to reach 20 °C to 25 °C.

Do not warm Libmyris in any other way. For example, do not warm it in a microwave or in hot water.

Do not use the pre-filled syringe if liquid has been frozen (even if thawed).

Figure A

Figure B

STEP 2: Check expiry date and liquid medicine

2.1 Check the expiry date on the pre-filled syringe label (see Figure C).

Do not use the pre-filled syringe if expiry (EXP) date has passed.
2.2 Check the liquid medicine in the syringe to ensure it is clear and colourless (Figure C).

Do not use the syringe and call your healthcare provider or pharmacist if liquid is cloudy, discoloured, or has flakes or particles in it.

Check expiry date and liquid medicine

EXP: MM/YYYY

Figure C

STEP 3: Gather supplies and wash hands

3.1 Place the following on a clean, flat surface (see Figure D):

1 single-use pre-filled syringe and alcohol pad.
1 cotton ball or gauze pad (not included).
Puncture-resistant sharps disposal container (not included). See Step 9.
3.2 Wash and dry your hands (see Figure E).

Figure D

Figure E

Injecting Libmyris pre-filled syringe

STEP 4: Choose and clean injection site

4.1 Choose an injection site (see Figure F):

On the front of your thighs or,

Your abdomen (belly) at least 5 cm from your navel (belly button).

Different from your last injection site (at least 3 cm from last injection site).

4.2 Wipe the injection site in a circular motion with the alcohol pad (see Figure G).

Do not inject through clothes.

Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis.

Figure F

Figure G

STEP 5: Remove needle cover

5.1 Hold the pre-filled syringe in one hand (see Figure H).
5.2 Gently pull the needle cover straight off with the other hand (see Figure H).

Throw the needle cover away.
Do not recap.
Do not touch the needle with your fingers or let the needle touch anything.
Hold the pre-filled syringe with the needle facing up. You may see air in the pre-filled

syringe. Slowly push the plunger in to push the air out through the needle.

You may see a drop of liquid at the end of the needle. This is normal.

Figure H

STEP 6: Grasp the syringe and pinch the skin

6.1 Hold the body of the pre-filled syringe in one hand between the thumb and index fingers, like a pencil (see Figure I). Do not pull back on the plunger at any time.
6.2 Gently squeeze (pinch) the area of cleaned skin at your injection site (abdomen or thigh) with your other hand (see Figure J). Hold the skin firmly.

Figure I

Figure J

STEP 7: Inject the medicine

7.1 Insert the needle into the pinched skin at about a 45-degree angle using a quick, dart-like motion (see Figure K).

After the needle is in, let go of the skin.
7.2 Slowly push the plunger all the way in until all of the liquid is injected, and the pre-filled syringe is empty (see Figure L).

r—-------

Or Thigh

Abdomen

Figure K

Figure L

STEP 8: Allow pre-filled syringe to retract needle from skin

8.1 Slowly lift your finger from the plunger. The plunger will move up with your finger and retract the needle from the site, into the needle guard (see Figure M).

The needle will not be retracted unless all the liquid is injected. Speak to your doctor, pharmacist or nurse if you think you have not given a full dose.

It is normal to see a spring around the plunger rod after the needle is retracted.

8.2 After completing the injection, place the cotton ball or gauze pad on the skin over the injection site.

Do not rub.
Slight bleeding at the injection site is normal.

Figure M

Disposing of Libmyris pre-filled syringe

STEP 9: Dispose used syringe into a sharps container

9.1 Put your used needles, syringes, and sharps in a sharps disposal container right away after use (see Figure N).

Do not throw away (dispose of) loose needles and syringes in the household trash.
9.2 The needle cover, alcohol pad, cotton ball or gauze pad, and packaging may be placed in your household trash.

Figure N

Additional disposal information If you do not have a sharps disposal container, you may use a household container that is:
made of a heavy-duty plastic,
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to

come out,

upright and stable during use,
leak-resistant, and
properly labelled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.

Do not dispose of your used sharps disposal container in your household trash. Do not recycle your used sharps disposal container.

If you have any questions contact your healthcare provider for help.

Package leaflet: Information for the patient

Libmyris 40 mg solution for injection in pre-filled pen adalimumab

Tf This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– Your doctor will also give you a Patient Reminder Card , which contains important safety

information that you need to be aware of before you begin using Libmyris and during treatment with Libmyris. Keep this Patient Reminder Card with you during your treatment and for 4 months after your last injection of Libmyris.

– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Libmyris is and what it is used for
2. What you need to know before you use Libmyris
3. How to use Libmyris
4. Possible side effects
5. How to store Libmyris
6. Contents of the pack and other information
7. Instructions for use

1. What Libmyris is and what it is used for

Libmyris contains the active substance adalimumab

Libmyris is used to treat:

Rheumatoid arthritis
Polyarticular juvenile idiopathic arthritis
Enthesitis-related arthritis
Ankylosing spondylitis
Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Psoriatic arthritis
Plaque psoriasis
Hidradenitis suppurativa
Crohn’s disease
Ulcerative colitis
Non-infectious uveitis

The active substance in Libmyris, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Libmyris can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Libmyris can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.

Your doctor will decide if Libmyris should be used with methotrexate or alone.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.

Your doctor will decide if Libmyris should be used with methotrexate or alone.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints that is usually associated with psoriasis.

Plaque psoriasis

Libmyris is used to treat

moderate to severe chronic plaque psoriasis in adults and
severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical

therapy and phototherapies have either not worked very well or are not suitable

Hidradenitis suppurativa

Libmyris is used to treat

moderate to severe hidradenitis suppurativa in adults and
moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years

Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract.

Libmyris is used to treat

moderate to severe Crohn’s disease in adults and
moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine.

Libmyris is used to treat

moderate to severe ulcerative colitis in adults and
moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

Non-infectious uveitis

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

Libmyris is used to treat

adults with non-infectious uveitis with inflammation affecting the back of the eye
children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

2. What you need to know before you use Libmyris

Do not use Libmyris

If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
If you have active tuberculosis or other severe infections (see “Warnings and precautions”). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems.
If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Libmyris.

Allergic reactions

If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Libmyris and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.

Infections

If you have an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Libmyris. If you are unsure, contact your doctor.
You might get infections more easily while you are receiving Libmyris treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include: o tuberculosis

o infections caused by viruses, fungi, parasites or bacteria

o severe infection in the blood (sepsis)

Tell your doctor if you live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.
If you are over 65 years you may be more likely to get infections while taking Libmyris. You and your doctor should pay special attention to signs of infection while you are being treated with Libmyris. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Tuberculosis

It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If you have active tuberculosis, do not use Libmyris.

o Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.

o If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.

Hepatitis B

Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of getting HBV.

o Your doctor should test you for HBV. In people who carry HBV, adalimumab can cause the virus to become active again.

o In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

Surgery or dental procedures

If you are about to have surgery or dental procedures tell your doctor that you are taking Libmyris. Your doctor may recommend temporary discontinuation of Libmyris.

Demyelinating disease

If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Libmyris. Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.

Vaccinations

Certain vaccines may cause infections and should not be given while receiving Libmyris.

o Check with your doctor before you receive any vaccines.

o It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Libmyris.

Heart failure

If you have mild heart failure and are being treated with Libmyris, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if you should receive Libmyris.

Fever, bruising, bleeding or looking pale

In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. Your doctor may decide to stop treatment. If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away.

Cancer

There have been very rare cases of certain kinds of cancer in children and adult patients taking adalimumab or other TNF blockers.

o People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).

o Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Libmyris.

o Cases of non-melanoma skin cancer have been observed in patients taking adalimumab.

o If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Autoimmune disease

On rare occasions, treatment with Libmyris could result in lupus-like syndrome. Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Children and adolescents

Vaccinations: if possible, children should be up to date with all vaccinations before using Libmyris.

Other medicines and Libmyris

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should not take Libmyris with medicines containing the following active substances due to increased risk of serious infection:

anakinra
abatacept.

Libmyris can be taken together with:

methotrexate
certain disease-modifying anti-rheumatic agents (for example, sulfasalazine,

hydroxychloroquine, leflunomide and injectable gold preparations)

steroids or pain medicine including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have questions, please ask your doctor.

Pregnancy and breast-feeding

You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Libmyris treatment.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
Libmyris should only be used during a pregnancy if needed.
According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Libmyris can be used during breast-feeding.
If you receive Libmyris during your pregnancy, your baby may have a higher risk for getting an infection.
It is important that you tell your baby’s doctors and other health care professionals about your Libmyris use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

Libmyris may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Libmyris.

Libmyris contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 0.4 ml, that is to say essentially ‘sodium-free’.

3. How to use Libmyris

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses for Libmyris in each of the approved uses are shown in the following table.

Your doctor may prescribe another strength of Libmyris if you need a different dose.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Age or body weight

How much and how often to take?

Notes

Adults

40 mg every other week

In rheumatoid arthritis, methotrexate is continued while using Libmyris. If your doctor decides that methotrexate is inappropriate, Libmyris can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your Libmyris therapy, your doctor may decide to give Libmyris 40 mg every week or 80 mg every other week.

Polyarticular juvenile idiopathic arthritis
Age or body weight	How much and how often to take?	Notes
Children, adolescents and adults from 2 years of age weighing 30 kg or more	40 mg every other week	Not applicable

Enthesitis-related arthritis
Age or body weight	How much and how often to take?	Notes
Children, adolescents and adults from 6 years of age weighing 30 kg or more	40 mg every other week	Not applicable

Plaque psoriasis
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose.	If you have an inadequate response, your doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents from 4 to 17 years of age weighing 30 kg or more	First dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.	Not applicable

Hidradenitis suppurativa
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (two 40 mg injections in one day) two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.	It is recommended that you use an antiseptic wash daily on the affected areas.
Adolescents from 12 to 17 years of age weighing 30 kg or more	First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week later.	If you have an inadequate response to Libmyris 40 mg every other week, your doctor may increase the dose to 40 mg every week or 80 mg every other week. It is recommended that you use an antiseptic wash daily on the affected areas.

Crohn’s disease
Age or body weight	How much and how often to take?	Notes
Children, adolescents and adults from 6 years of age weighing 40 kg or more	First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later. If a faster response is required, the doctor may prescribe a first dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week.	Y our doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents from 6 to 17 years of age weighing less than 40 kg	First dose of 40 mg, followed by 20 mg two weeks later. If a faster response is required, the doctor may prescribe a first dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every other week.	Y our doctor may increase the dose frequency to 20 mg every week. *
Libmyris is only available as 4 syringe. Thus, it is not possible dose.	0 mg pre-filled syringe, 40 mg pre-filled pen and 80 mg pre-filled o administer Libmyris to patients that require less than a full 40 mg
Ulcerative colitis
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later. Thereafter, the usual dose is 40 mg every other week.	Y our doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents from 6 years of age weighing less than 40 kg	First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg (one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.	Y ou should continue taking adalimumab at your usual dose, even after turning 18 years of age.

Children and adolescents from 6 years of age weighing 40 kg or more

Y ou should continue taking adalimumab at your usual dose, even after turning 18 years of age.

Non-infectious uveitis
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week after the first dose.	Corticosteroids or other medicines that influence the immune system may be continued while using Libmyris. Libmyris can also be given alone.
Children and adolescents from 2 years of age weighing at least 30 kg	40 mg every other week	Y our doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week. Libmyris is recommended for use in combination with methotrexate.

Method and route of administration

Libmyris is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Libmyris are provided in section 7, “Instructions for use”.

If you use more Libmyris than you should

If you forget to use Libmyris

If you stop using Libmyris

The decision to stop using Libmyris should be discussed with your doctor. Your symptoms may return if you stop using Libmyris.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Tell your doctor immediately if you notice any of the following

severe rash, hives or other signs of allergic reaction

swollen face, hands, feet

trouble breathing, swallowing

shortness of breath with physical activity or upon lying down or swelling of the feet

Tell your doctor as soon as possible , if you notice any of the following

signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
feeling weak or tired
coughing
tingling
numbness
double vision
arm or leg weakness
a bump or open sore that doesn't heal
signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness

The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people)

injection site reactions (including pain, swelling, redness or itching)
respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
headache
abdominal pain
nausea and vomiting
rash
musculoskeletal pain

Common (may affect up to 1 in 10 people)

serious infections (including blood poisoning and influenza)
intestinal infections (including gastroenteritis)
skin infections (including cellulitis and shingles)
ear infections
oral infections (including tooth infections and cold sores)
reproductive tract infections
urinary tract infection
fungal infections
joint infections
benign tumours
skin cancer
allergic reactions (including seasonal allergy)
dehydration
mood swings (including depression)
anxiety
difficulty sleeping
sensation disorders such as tingling, prickling or numbness
migraine
nerve root compression (including low back pain and leg pain)
vision disturbances
eye inflammation
inflammation of the eye lid and eye swelling
vertigo (feeling of dizziness or spinning)
sensation of heart beating rapidly
high blood pressure
flushing
haematoma (collection of blood outside of blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heart burn)
acid reflux disease
sicca syndrome (including dry eyes and dry mouth)
itching
itchy rash
bruising
inflammation of the skin (such as eczema)
breaking of finger nails and toe nails
increased sweating
hair loss
new onset or worsening of psoriasis
muscle spasms
blood in urine
kidney problems
chest pain
oedema (swelling)
fever
reduction in blood platelets which increases risk of bleeding or bruising
impaired healing

Uncommon (may affect up to 1 in 100 people)

opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
neurological infections (including viral meningitis)
eye infections
bacterial infections
diverticulitis (inflammation and infection of the large intestine)
cancer
cancer that affects the lymph system
melanoma
immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting

as sarcoidosis)

vasculitis (inflammation of blood vessels)
tremor (shaking)
neuropathy (disorder of the nerves)
stroke
hearing loss, buzzing
sensation of heart beating irregularly such as skipped beats
heart problems that can cause shortness of breath or ankle swelling
heart attack
a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel
lung diseases causing shortness of breath (including inflammation)
pulmonary embolism (blockage in an artery of the lung)
pleural effusion (abnormal collection of fluid in the pleural space)
inflammation of the pancreas which causes severe pain in the abdomen and back
difficulty in swallowing
facial oedema (swelling of the face)
gallbladder inflammation, gallbladder stones

fatty liver

night sweats

scar

abnormal muscle breakdown

systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)

sleep interruptions

impotence

inflammations

Rare (may affect up to 1 in 1,000 people)

leukaemia (cancer affecting the blood and bone marrow)
severe allergic reaction with shock
multiple sclerosis
nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
heart stops pumping
pulmonary fibrosis (scarring of the lung)
intestinal perforation (hole in the intestine)
hepatitis
reactivation of hepatitis B
autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
cutaneous vasculitis (inflammation of blood vessels in the skin)
Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
facial oedema (swelling of the face) associated with allergic reactions
erythema multiforme (inflammatory skin rash)
lupus-like syndrome
angioedema (localised swelling of the skin)
lichenoid skin reaction (itchy reddish-purple skin rash)

Not known (frequency cannot be estimated from the available data)

hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
Merkel cell carcinoma (a type of skin cancer)
Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
liver failure
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
weight gain (for most patients, the weight gain was small)

Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people)

low blood measurements for white blood cells
low blood measurements for red blood cells
increased lipids in the blood
elevated liver enzymes

Common (may affect up to 1 in 10 people)

high blood measurements for white blood cells
low blood measurements for platelets
increased uric acid in the blood
abnormal blood measurements for sodium
low blood measurements for calcium
low blood measurements for phosphate
high blood sugar
high blood measurements for lactate dehydrogenase
autoantibodies present in the blood
low blood potassium

Uncommon (may affect up to 1 in 100 people)

elevated bilirubin measurement (liver blood test)

Rare (may affect up to 1 in 1,000 people)

low blood measurements for white blood cells, red blood cells and platelet count

Reporting of side effects

5. How to store Libmyris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C). Do not freeze.

Keep the pre-filled pen in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example when you are travelling), a single Libmyris pre-filled pen may be stored at 20 °C to 25 °C for a maximum period of up to 14 days – be sure to protect it from light. Once removed from the refrigerator for storage at 20 °C to 25 °C, the pen must be used within the 14 days or discarded , even if it is returned to the refrigerator.

You should record the date when the pen is first removed from refrigerator and the date after which it should be discarded.

Do not use this medicine if the liquid is cloudy, discoloured, or has flakes or particles in it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Libmyris contains

– The active substance is adalimumab
– The other ingredients are sodium chloride, sucrose, polysorbate 80, water for injections, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment)

What Libmyris looks like and contents of the pack

Libmyris 40 mg solution for injection in pre-filled pen is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml preservative-free solution for injection in pre-filled needle-based injection system (autoinjector) containing a pre-filled glass syringe with a fixed needle and a plunger stopper (bromobutyl rubber, latex-free). The pen is a single use, disposable, handheld, mechanical injection device.

Each pack contains 1, 2 or 6 pre-filled pen(s) packed in a blister, with 1, 2 or 6 alcohol pad(s).

Not all pack sizes may be marketed.

Libmyris may be available as a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

STADA Arzneimittel AG

Stadastrasse 2–18

61118 Bad Vilbel

Germany

Manufacturer

Ivers-Lee CSM

Marie-Curie-Str.8

79539 Lorrach

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

Belgie/Belgique/Belgien

EG (Eurogenerics) NV

Tél/Tel: +32 24797878

Efcnrapua

STADA Bulgaria EOOD

Ten.: +359 29624626

Česká republika

STADA PHARMA CZ s.r.o.

Tel: +420 257888111

Danmark

STADA Nordic ApS

Tlf: +45 44859999

Deutschland

STADAPHARM GmbH

Tel: +49 61016030

Eesti

UAB „STADA Baltics“

Tel: +370 52603926

EZZáSa

STADA Arzneimittel AG

Tql: +30 2106664667

España

Laboratorio STADA, S.L.

Tel: +34 934738889

Lietuva

UAB „STADA Baltics“

Tel: +370 52603926

Luxembourg/Luxemburg

EG (Eurogenerics) NV

Tel/Tel: +32 4797878

Magyarorszag

STADA Hungary Kft

Tel.: +36 18009747

Malta

Pharma.MT Ltd

Tel: +356 21337008

Nederland

Centrafarm B.V.

Tel.: +31 765081000

Norge

STADA Nordic ApS

Tlf: +45 44859999

Österreich

STADA Arzneimittel GmbH

Tel: +43 136785850

Polska

STADA Poland Sp. z.o o.

Tel: +48 227377920

France

Biogaran SAS

Tél: +33 155724100

Portugal

Stada, Lda.

Tel: +351 211209870

Hrvatska

STADA d.o.o.

Tel: +385 13764111

Romania

STADA M&D SRL

Tel: +40 213160640

Ireland

Clonmel Healthcare Ltd.

Tel: +353 526177777

Slovenija

Stada d.o.o.

Tel: +386 15896710

Ísland

STADA Arzneimittel AG

Sími: +49 61016030

Slovenská republika

STADA PHARMA Slovakia, s.r.o.

Tel: +421 252621933

Italia

EG SpA

Tel: +39 028310371

Suomi/Finland

STADA Nordic ApS, Suomen sivuliike

Puh/Tel: +358 207416888

Kùnpoç

STADA Arzneimittel AG

TnX: +30 2106664667

Sverige

STADA Nordic ApS

Tel: +45 44859999

Latvija

UAB „STADA Baltics“

Tel: +370 52603926

United Kingdom (Northern Ireland)

STADA Arzneimittel AG

Tel: +49 61016030

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

7. Instructions for use

INSTRUCTIONS FOR USE

Libmyris (adalimumab) pre-filled pen

40 mg/0.4 ml solution for injection, for subcutaneous use

Read carefully these instructions for use before using the Libmyris single-use pre-filled pen

Before injecting

Your healthcare provider should show you how to use Libmyris single-use pre-filled pen before you use it for the first time.

If you have used another adalimumab pen on the market in the past, this pen works differently from other pens. Please read these instructions for use completely so that you understand how to properly use the Libmyris pre-filled pen before injecting.

Important information

Do not use the pen and call your healthcare provider or pharmacist if

Liquid is cloudy, discoloured, or has flakes or particles in it.
Expiry date has passed.
Pen has been left in direct sunlight.
The pen has been dropped or crushed.

Keep the clear cap on until right before injection. Keep Libmyris single-use pre-filled pen out of reach of children.

Read instructions on all pages before using the Libmyris single-use pre-filled pen.

Libmyris pre-filled pen

Grey Body Grip Area

Inspection Window

Orange Needle Sleeve

Needle

Clear Cap

How should I store Libmyris single-use pre-filled pen?

Store Libmyris single-use pre-filled pen in the original carton in the refrigerator between 2 °C to 8 °C. If needed, for example when you are traveling, you may also store Libmyris pre-filled pen at 20 °C to 25 °C for up to 14 days.

See the section 5 in the package leaflet for more details.

STEP 1: Take Libmyris pre-filled pen out of refrigerator and leave at 20 °C to 25 °C for 15 to 30 minutes before injecting

Step 1a. Take Libmyris pre-filled pen out of the refrigerator (see Figure A).

Step 1b. Leave Libmyris pre-filled pen at 20 °C to 25 °C for 15 to 30 minutes before injecting (see Figure B).

Do not remove the clear cap while allowing Libmyris pre-filled pen to reach 20 °C to 25 °C.
Do not warm Libmyris pre-filled pen in any other way. For example, do not warm it in a

microwave or in hot water.

Do not use the pre-filled pen if liquid has been frozen (even if thawed).

Figure A

STEP 2: Check expiry date, gather supplies and wash hands

Step 2a. Check the expiry date on the Libmyris pre-filled pen label (see Figure C).

Do not use the Libmyris pre-filled pen if expiry date has passed.

Figure C

Step 2b. Place the following on a clean, flat surface (see Figure D):

1 Libmyris pre-filled pen and alcohol pad.
1 cotton ball or gauze pad (not included).

Puncture-resistant sharps disposal container (not included). See Step 9 at the end of these instructions for use on how to throw away (dispose of) your Libmyris pre-filled pen.

Step 2c. Wash and dry your hands (see Figure E).

Figure D

Figure E

STEP 3: Choose and clean injection site

Step 3a. Choose an injection site (see Figure F):

On the front of your thighs or,
Your abdomen (belly) at least 5 cm from your navel (belly button).
At least 3 cm from your last injection site.

Step 3b. Wipe the injection site in a circular motion with the alcohol pad (see Figure G).

Do not inject through clothes.

Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques.

Figure F

Figure G

STEP 4: Check medicine in inspection window

Step 4a. Hold the Libmyris pre-filled pen with the grey body grip area facing up. Check the inspection window (see Figure H).

It is normal to see 1 or more bubbles in the window.
Make sure the liquid is clear and colourless.

Do not use the Libmyris pre-filled pen if the liquid is cloudy, discoloured, or has flakes or has particles in it.

Do not use the Libmyris pre-filled pen if it has been dropped or crushed.

Figure H

STEP 5: Remove clear cap

Step 5a. Pull the clear cap straight off (see Figure I).

It is normal to see a few drops of liquid come out of the needle.

Step 5b. Throw the clear cap away.

Do not put the clear cap back on the pen. This may damage the needle. The pen is ready to use after the clear cap has been removed.

Step 5c. Turn the Libmyris pre-filled pen so that the orange needle sleeve points toward the injection site.

Figure I

STEP 6: Pinch skin and position Libmyris pre-filled pen over injection site

Step 6a. Squeeze the skin at your injection site to make a raised area and hold it firmly.

Step 6b. Place the orange needle sleeve straight (90° angle) against the injection site (see Figure J).

Hold the pen so that you can see the inspection window.

Figure J

STEP 7: Give injection

Step 7a. Push and keep pushing the pen down against the injection site (see Figure K).

The first ‘click’ will signal the start of the injection (see Figure K). It may take up to 10 seconds after the first ‘click’ to complete.
Keep pushing the pen down against the injection site.
The injection is complete when the orange indicator has stopped moving and you may hear a second 'click’ (see Figure L).

Do not lift up, or let go of the pressure from the injection site, until you have confirmed the injection is complete.

Figure K Figure L

STEP 8: Remove Libmyris pre-filled pen from skin with care

Step 8a. When the injection is completed, slowly pull the Libmyris pre-filled pen from the skin. The orange needle sleeve will cover the needle tip (see Figure M).

If there are more than a few drops of liquid on the injection site, contact your healthcare provider for help.

Step 8b. After completing the injection, place a cotton ball or gauze pad on the skin of the injection site.

Do not rub.

Slight bleeding at the injection site is normal.

Figure M

STEP 9: How should I dispose of the used Libmyris pre-filled pen?

Step 9a. Put your used needles, pens and sharps in a sharps disposal container right away after use (see Figure N).

Do not throw away (dispose of) the pen in the household trash.

Step 9b. The clear caps, alcohol pad, cotton ball or gauze pad, and packaging may be placed in your household trash.

If you do not have a sharps disposal container, you may use a household container that is:

made of a heavy-duty plastic,
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
upright and stable during use,
leak-resistant, and
properly labelled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.

Do not dispose of your used sharps disposal container in your household trash.

Do not recycle your used sharps disposal container.

Figure N

Package leaflet: Information for the patient

Libmyris 80 mg solution for injection in pre-filled syringe

adalimumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– Your doctor will also give you a Patient Reminder Card , which contains important safety information that you need to be aware of before you begin using Libmyris and during treatment with Libmyris. Keep this Patient Reminder Card with you during your treatment and for 4 months after your last injection of Libmyris.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Libmyris is and what it is used for
2. What you need to know before you use Libmyris
3. How to use Libmyris
4. Possible side effects
5. How to store Libmyris
6. Contents of the pack and other information
7. Instructions for use

1. What Libmyris is and what it is used for

Libmyris contains the active substance adalimumab

Libmyris is used to treat:

Rheumatoid arthritis
Plaque psoriasis
Hidradenitis suppurativa
Crohn’s disease
Ulcerative colitis
Non-infectious uveitis

The active substance in Libmyris, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Libmyris can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Libmyris can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.

Your doctor will decide if Libmyris should be used with methotrexate or alone.

Plaque psoriasis

Libmyris is used to treat moderate to severe chronic plaque psoriasis in adults.

Hidradenitis suppurativa

Libmyris is used to treat

moderate to severe hidradenitis suppurativa in adults and
moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract.

Libmyris is used to treat

moderate to severe Crohn’s disease in adults and
moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine.

Libmyris is used to treat

moderate to severe ulcerative colitis in adults and
moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years

You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

Non-infectious uveitis

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

Libmyris is used to treat

adults with non-infectious uveitis with inflammation affecting the back of the eye
children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the

front of the eye.

This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Libmyris works by reducing this inflammation. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.

2. What you need to know before you use Libmyris

Do not use Libmyris

– If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
– If you have active tuberculosis or other severe infections (see “Warnings and precautions”). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems.
– If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before using Libmyris.

Allergic reactions

If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Libmyris and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.

Infections

If you have an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer), consult your doctor before starting Libmyris. If you are unsure, contact your doctor.
You might get infections more easily while you are receiving Libmyris treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include: o tuberculosis

o infections caused by viruses, fungi, parasites or bacteria

o severe infection in the blood (sepsis)

Tell your doctor if you live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.
If you are over 65 years you may be more likely to get infections while taking Libmyris. You and your doctor should pay special attention to signs of infection while you are being treated with Libmyris. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Tuberculosis

It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If you have active tuberculosis, do not use Libmyris.

o As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Libmyris. This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example, chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your Patient Reminder Card.

o Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.

o If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.

Hepatitis B

Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of getting HBV.

o Your doctor should test you for HBV. In people who carry HBV, adalimumab can cause the virus to become active again.

o In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

Surgery or dental procedures

If you are about to have surgery or dental procedures tell your doctor that you are taking Libmyris. Your doctor may recommend temporary discontinuation of Libmyris.

Demyelinating disease

If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Libmyris. Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.

Vaccinations

Certain vaccines may cause infections and should not be given while receiving Libmyris.

o Check with your doctor before you receive any vaccines.

o It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Libmyris.

Heart failure

If you have mild heart failure and are being treated with Libmyris, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if you should receive Libmyris.

Fever, bruising, bleeding or looking pale

In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. Your doctor may decide to stop treatment. If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away.

Cancer

There have been very rare cases of certain kinds of cancer in children and adult patients taking adalimumab or other TNF blockers.

o Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Libmyris.

o Cases of non-melanoma skin cancer have been observed in patients taking adalimumab.

o If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Autoimmune disease

On rare occasions, treatment with Libmyris could result in lupus-like syndrome. Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Children and adolescents

Vaccinations: if possible, children should be up to date with all vaccinations before using Libmyris.

Other medicines and Libmyris

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should not take Libmyris with medicines containing the following active substances due to increased risk of serious infection:

anakinra
abatacept.

Libmyris can be taken together with:

methotrexate
certain disease-modifying anti-rheumatic agents (for example, sulfasalazine,

hydroxychloroquine, leflunomide and injectable gold preparations)

steroids or pain medicine including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have questions, please ask your doctor.

Pregnancy and breast-feeding

You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Libmyris treatment.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
Libmyris should only be used during a pregnancy if needed.
According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Libmyris can be used during breast-feeding.
If you receive Libmyris during your pregnancy, your baby may have a higher risk for getting an infection.
It is important that you tell your baby’s doctors and other health care professionals about your Libmyris use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

Libmyris may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after using Libmyris.

Libmyris contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 0.8 ml, that is to say essentially ‘sodium-free’.

3. How to use Libmyris

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended doses for Libmyris in each of the approved uses are shown in the following table.

Your doctor may prescribe another strength of Libmyris if you need a different dose.

Rheumatoid arthritis

Age or body weight

How much and how often to take?

Notes

Adults

40 mg every other week

In rheumatoid arthritis, methotrexate is continued while using Libmyris. If your doctor decides that methotrexate is inappropriate, Libmyris can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your Libmyris therapy, your doctor may decide to give Libmyris 40 mg every week or 80 mg every other week.

Plaque psoriasis
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.	If you have an inadequate response, your doctor may increase the dose to 40 mg every week or 80 mg every other week.

Hidradenitis suppurativa
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by an 80 mg dose (one 80 mg injection) two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.	It is recommended that you use an antiseptic wash daily on the affected areas.
Adolescents from 12 to 17 years of age weighing 30 kg or more	First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week later.	If you have an inadequate response to Libmyris 40 mg every other week, your doctor may increase the dose to 40 mg every week or 80 mg every other week. It is recommended that you use an antiseptic wash daily on the affected areas.

Crohn’s disease
Age or body weight	How much and how often to take?	Notes
Children, adolescents and adults from 6 years of age weighing 40 kg or more	First dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later. If a faster response is required, the doctor may prescribe a first dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.	Y our doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents from 6 to 17 years of age weighing less than 40 kg	The Libmyris 80 mg pre-filled syringe should not be used in children or adolescents weighing less than 40 kg with Crohn’s disease, since it is not possible to administer doses less than 80 mg.

Ulcerative colitis
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.	Y our doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents from 6 years of age weighing less than 40 kg	First dose of 80 mg (one 80 mg injection), followed by 40 mg (one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.	Y ou should continue taking adalimumab at your usual dose, even after turning 18 years of age.
Children and adolescents from 6 years of age weighing 40 kg or more	First dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later. Thereafter, the usual dose is 80 mg every other week.	Y ou should continue taking adalimumab at your usual dose, even after turning 18 years of age.

Non-infectious uveitis
Age or body weight	How much and how often to take?	Notes
Adults	First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.	Corticosteroids or other medicines that influence the immune system may be continued while using Libmyris. Libmyris can also be given alone.
Children and adolescents from 2 years of age weighing 30 kg or more	40 mg every other week	Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week. Libmyris is recommended for use in combination with methotrexate.

Method and route of administration

Libmyris is administered by injection under the skin (by subcutaneous injection).

Detailed instructions on how to inject Libmyris are provided in section 7 “Instructions for use”.

If you use more Libmyris than you should

If you forget to use Libmyris

If you stop using Libmyris

The decision to stop using Libmyris should be discussed with your doctor. Your symptoms may return if you stop using Libmyris.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Tell your doctor immediately if you notice any of the following

severe rash, hives or other signs of allergic reaction
swollen face, hands, feet
trouble breathing, swallowing
shortness of breath with physical activity or upon lying down or swelling of the feet

Tell your doctor as soon as possible, if you notice any of the following

signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
feeling weak or tired
coughing
tingling
numbness
double vision
arm or leg weakness
a bump or open sore that doesn't heal
signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness

The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people)

injection site reactions (including pain, swelling, redness or itching)
respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
headache
abdominal pain
nausea and vomiting
rash
musculoskeletal pain

Common (may affect up to 1 in 10 people)

serious infections (including blood poisoning and influenza)
intestinal infections (including gastroenteritis)
skin infections (including cellulitis and shingles)
ear infections
oral infections (including tooth infections and cold sores)
reproductive tract infections
urinary tract infection
fungal infections
joint infections
benign tumours
skin cancer
allergic reactions (including seasonal allergy)
dehydration
mood swings (including depression)
anxiety
difficulty sleeping
sensation disorders such as tingling, prickling or numbness
migraine
nerve root compression (including low back pain and leg pain)
vision disturbances
eye inflammation
inflammation of the eye lid and eye swelling
vertigo (feeling of dizziness or spinning)
sensation of heart beating rapidly
high blood pressure
flushing
haematoma (collection of blood outside of blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heart burn)
acid reflux disease
sicca syndrome (including dry eyes and dry mouth)
itching
itchy rash
bruising
inflammation of the skin (such as eczema)
breaking of finger nails and toe nails
increased sweating
hair loss
new onset or worsening of psoriasis
muscle spasms
blood in urine
kidney problems
chest pain
oedema (swelling)
fever
reduction in blood platelets which increases risk of bleeding or bruising
impaired healing

Uncommon (may affect up to 1 in 100 people)

opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
neurological infections (including viral meningitis)
eye infections
bacterial infections
diverticulitis (inflammation and infection of the large intestine)
cancer
cancer that affects the lymph system
melanoma
immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
vasculitis (inflammation of blood vessels)
tremor (shaking)
neuropathy (disorder of the nerves)
stroke
hearing loss, buzzing
sensation of heart beating irregularly such as skipped beats
heart problems that can cause shortness of breath or ankle swelling
heart attack
a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel
lung diseases causing shortness of breath (including inflammation)
pulmonary embolism (blockage in an artery of the lung)
pleural effusion (abnormal collection of fluid in the pleural space)
inflammation of the pancreas which causes severe pain in the abdomen and back
difficulty in swallowing
facial oedema (swelling of the face)
gallbladder inflammation, gallbladder stones
fatty liver
night sweats
scar
abnormal muscle breakdown
systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
sleep interruptions
impotence
inflammations

Rare (may affect up to 1 in 1,000 people)

leukaemia (cancer affecting the blood and bone marrow)
severe allergic reaction with shock
multiple sclerosis
nerve disorders (such as eye nerve inflammation and Guillain-Barre syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
heart stops pumping
pulmonary fibrosis (scarring of the lung)
intestinal perforation (hole in the intestine)
hepatitis
reactivation of hepatitis B
autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
cutaneous vasculitis (inflammation of blood vessels in the skin)
Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
facial oedema (swelling of the face) associated with allergic reactions
erythema multiforme (inflammatory skin rash)
lupus-like syndrome
angioedema (localised swelling of the skin)
lichenoid skin reaction (itchy reddish-purple skin rash)

Not known (frequency cannot be estimated from the available data)

hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
Merkel cell carcinoma (a type of skin cancer)
Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
liver failure
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
weight gain (for most patients, the weight gain was small)

Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:

Very common (may affect more than 1 in 10 people)

low blood measurements for white blood cells
low blood measurements for red blood cells
increased lipids in the blood
elevated liver enzymes

Common (may affect up to 1 in 10 people)

high blood measurements for white blood cells
low blood measurements for platelets
increased uric acid in the blood
abnormal blood measurements for sodium
low blood measurements for calcium
low blood measurements for phosphate
high blood sugar
high blood measurements for lactate dehydrogenase
autoantibodies present in the blood
low blood potassium

Uncommon (may affect up to 1 in 100 people)

elevated bilirubin measurement (liver blood test)

Rare (may affect up to 1 in 1,000 people)

low blood measurements for white blood cells, red blood cells and platelet count

Reporting of side effects

5. How to store Libmyris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Alternative Storage:

When needed (for example when you are travelling), a single Libmyris pre-filled syringe may be stored at 20 °C to 25 °C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for storage at 20 °C to 25 °C, the syringe must be used within 14 days or discarded , even if it is returned to the refrigerator.

You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.

Do not use this medicine if the liquid is cloudy, discoloured, or has flakes or particles in it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Libmyris contains

– The active substance is adalimumab
– The other ingredients are sodium chloride, sucrose, polysorbate 80, water for injections, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment)

What Libmyris looks like and contents of the pack

Libmyris 80 mg solution for injection in pre-filled syringe with needle guard is supplied as a sterile solution of 80 mg adalimumab dissolved in 0.8 ml preservative-free solution.

The Libmyris pre-filled syringe is a glass syringe containing a solution of adalimumab.

Each pack contains 1 pre-filled syringe packed in a blister, with 1 alcohol pad.

Marketing Authorisation Holder

STADA Arzneimittel AG

Stadastrasse 2–18

61118 Bad Vilbel

Germany

Manufacturer

Ivers-Lee CSM

Marie-Curie-Str.8

79539 Lorrach

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgique/Belgien

EG (Eurogenerics) NV Tél/Tel: +32 24797878

Lietuva

UAB „STADA Baltics“

Tel: +370 52603926

Etnrapua

STADA Bulgaria EOOD

Ten.: +359 29624626

Luxembourg/Luxemburg

EG (Eurogenerics) NV Tél/Tel: +32 4797878

Česká republika

STADA PHARMA CZ s.r.o.

Tel: +420 257888111

Magyarország

STADA Hungary Kft

Tel.: +36 18009747

Danmark

STADA Nordic ApS

Tlf: +45 44859999

Malta

Pharma.MT Ltd

Tel: +356 21337008

Deutschland

STADAPHARM GmbH

Tel: +49 61016030

Nederland

Centrafarm B.V.

Tel.: +31 765081000

Eesti

UAB „STADA Baltics“

Tel: +370 52603926

Norge

STADA Nordic ApS

Tlf: +45 44859999

EMáSa

STADA Arzneimittel AG

Tql: +30 2106664667

Österreich

STADA Arzneimittel GmbH

Tel: +43 136785850

España

Laboratorio STADA, S.L.

Tel: +34 934738889

Polska

STADA Poland Sp. z.o o.

Tel: +48 227377920

France

Biogaran SAS

Tél: +33 155724100

Portugal

Stada, Lda.

Tel: +351 211209870

Hrvatska

STADA d.o.o.

Tel: +385 13764111

Romania

STADA M&D SRL

Tel: +40 213160640

Ireland

Clonmel Healthcare Ltd.

Tel: +353 526177777

Slovenija

Stada d.o.o.

Tel: +386 15896710

Ísland

STADA Arzneimittel AG

Sími: +49 61016030

Slovenská republika

STADA PHARMA Slovakia, s.r.o.

Tel: +421 252621933

Italia

EG SpA

Tel: +39 028310371

Suomi/Finland

STADA Nordic ApS, Suomen sivuliike

Puh/Tel: +358 207416888

Kúnpog

STADA Arzneimittel AG

Tql: +30 2106664667

Sverige

STADA Nordic ApS

Tel: +45 44859999

Latvija

UAB „STADA Baltics

Tel: +370 52603926

United Kingdom (Northern Ireland)

STADA Arzneimittel AG

Tel: +49 61016030

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

7. Instructions for use

INSTRUCTIONS FOR USE

Libmyris (adalimumab) pre-filled syringe

80 mg/0.8 ml solution for injection, for subcutaneous use

Read carefully these instructions for use before using the Libmyris single-use pre-filled syringe.

Libmyris pre-filled syringe

■< Plunger

Important information you need to know before injecting Libmyris single-use pre-filled syringe.

Important information:

For subcutaneous injection only.
Do not use the syringe and call your healthcare provider or pharmacist if:

Liquid is cloudy, discoloured, or has flakes or particles in it.
Expiry date has passed.
Liquid has been frozen (even if thawed) or left in direct sunlight.
The pre-filled syringe has been dropped or crushed.

Keep the needle cover on until right before injection. Keep Libmyris out of reach of children.
See the section 5 in the package leaflet for how to store Libmyris single-use pre-filled syringe.

Before injecting:

Your healthcare provider should show you how to use Libmyris single-use pre-filled syringe before you use it for the first time.

Current adalimumab syringe users:

Even if you have used other adalimumab syringes on the market in the past, please read the instructions completely so that you understand how to properly use this device before attempting to inject.

Questions about using the Libmyris pre-filled syringe?

Talk to your healthcare provider if you have any questions.

Preparing to inject Libmyris pre-filled syringe

STEP 1: Take syringe out of refrigerator and warm to 20 °C to 25 °C for 15–30 minutes

1.1 Take Libmyris out of the refrigerator (see Figure A).
1.2 Leave Libmyris at 20 °C to 25 °C for 15 to 30 minutes before injecting (see Figure B).

Do not remove the grey needle cover while allowing Libmyris to reach 20 °C to 25 °C.

Do not warm Libmyris in any other way. For example, do not warm it in a microwave or in hot water.

Do not use the pre-filled syringe if liquid has been frozen (even if thawed).

STEP 2: Check expiry date and liquid medicine

2.1 Check the expiry date on the pre-filled syringe label (see Figure C).

Do not use the pre-filled syringe if expiry (EXP) date has passed.

2.2 Check the liquid medicine in the syringe to ensure it is clear and colourless (Figure C).

Do not use the syringe and call your healthcare provider or pharmacist if liquid is cloudy, discoloured, or has flakes or particles in it.

Check expiry date and liquid medicine

EXP: MM/YYYY

Figure C

STEP 3: Gather supplies and wash hands

3.1 Place the following on a clean, flat surface (see Figure D):

1 single-use pre-filled syringe and alcohol pad.
1 cotton ball or gauze pad (not included).

Puncture-resistant sharps disposal container (not included). See Step 9.

3.2 Wash and dry your hands (see Figure E).

Alcohol pad

Figure D

Figure E

Injecting Libmyris pre-filled syringe

STEP 4: Choose and clean injection site

4.1 Choose an injection site (see Figure F):

On the front of your thighs or,

Your abdomen (belly) at least 5 cm from your navel (belly button).

Different from your last injection site (at least 3 cm from last injection site).

4.2 Wipe the injection site in a circular motion with the alcohol pad (see Figure G).

Do not inject through clothes.

Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis.

Figure F

Figure G

STEP 5: Remove needle cover

5.1 Hold the pre-filled syringe in one hand (see Figure H).
5.2 Gently pull the needle cover straight off with the other hand (see Figure H).

Throw the needle cover away.
Do not recap.
Do not touch the needle with your fingers or let the needle touch anything.
Hold the pre-filled syringe with the needle facing up. You may see air in the pre-filled

syringe. Slowly push the plunger in to push the air out through the needle.

You may see a drop of liquid at the end of the needle. This is normal.

Figure H

STEP 6: Grasp the syringe and pinch the skin

6.1 Hold the body of the pre-filled syringe in one hand between the thumb and index fingers, like a pencil (see Figure I). Do not pull back on the plunger at any time.
6.2 Gently squeeze (pinch) the area of cleaned skin at your injection site (abdomen or thigh) with your other hand (see Figure J). Hold the skin firmly.

Figure I

Figure J

STEP 7: Inject the medicine

7.1 Insert the needle into the pinched skin at about a 45-degree angle using a quick, dart-like motion (see Figure K).

After the needle is in, let go of the skin.

7.2 Slowly push the plunger all the way in until all of the liquid is injected, and the pre-filled syringe is empty (see Figure L).

r—-------

Or Thigh

Abdomen

Figure K

Figure L

STEP 8: Allow pre-filled syringe to retract needle from skin

8.1 Slowly lift your finger from the plunger. The plunger will move up with your finger and retract the needle from the site, into the needle guard (see Figure M).

The needle will not be retracted unless all the liquid is injected. Speak to your doctor, pharmacist or nurse if you think you have not given a full dose.

It is normal to see a spring around the plunger rod after the needle is retracted.

8.2 After completing the injection, place the cotton ball or gauze pad on the skin over the injection site.

Do not rub.
Slight bleeding at the injection site is normal.

Figure M

Disposing of Libmyris pre-filled syringe

STEP 9: Dispose used syringe into a sharps container

9.1 Put your used needles, syringes, and sharps in a sharps disposal container right away after use (see Figure N).

Do not throw away (dispose of) loose needles and syringes in the household trash.

9.2 The needle cover, alcohol pad, cotton ball or gauze pad, and packaging may be placed in your household trash.

Figure N

Additional disposal information If you do not have a sharps disposal container, you may use a household container that is:

made of a heavy-duty plastic,
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to

come out,

upright and stable during use,
leak-resistant, and
properly labelled to warn of hazardous waste inside the container.

Libmyris - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - Libmyris

1. What Libmyris is and what it is used for

2. What you need to know before you use Libmyris

3. How to use Libmyris

4. Possible side effects

5. How to store Libmyris

6. Contents of the pack and other information

7. Instructions for use

1. What Libmyris is and what it is used for

2. What you need to know before you use Libmyris

3. How to use Libmyris

4. Possible side effects

5. How to store Libmyris

6. Contents of the pack and other information

7. Instructions for use

1. What Libmyris is and what it is used for

2. What you need to know before you use Libmyris

3. How to use Libmyris

4. Possible side effects

5. How to store Libmyris

6. Contents of the pack and other information

7. Instructions for use