Patient leaflet - Humira

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Humira 20 mg solution for injection in pre-filled syringe adalimumab

Read all of this leaflet carefully before your child starts using this medicine because it contains important information.

– 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 your child begins using Humira and during treatment with Humira. Keep this Patient Reminder Card with you or your child.

– If you have any questions, ask your doctor or pharmacist.
– This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child.
– If your child gets 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 Humira is and what it is used for
2. What you need to know before your child uses Humira
3. How to use Humira
4. Possible side effects
5 How to store Humira
6. Contents of the pack and other information
7. Injecting Humira

1. What Humira is and what it is used for

Humira contains the active substance adalimumab.

Humira is intended for the treatment of the inflammatory diseases described below:

Polyarticular juvenile idiopathic arthritis
Enthesitis-related arthritis
Paediatric plaque psoriasis
Paediatric Crohn’s disease
Paediatric uveitis

The active ingredient in Humira, 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, Humira decreases the process of inflammation in these diseases.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appears in childhood.

Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Humira to treat his/her polyarticular juvenile idiopathic arthritis.

Your doctor will decide if Humira 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.

Humira is used to treat enthesitis-related arthritis in patients from 6 years of age. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Humira to treat his/her enthesitis-related arthritis.

Paediatric 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. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to an increased production of skin cells.

Humira is used to treat 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.

Paediatric Crohn’s disease

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

Humira is used to treat moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Humira to reduce the signs and symptoms of his/her disease.

Paediatric uveitis

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

Humira is used to treat children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye

Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Humira to reduce the signs and symptoms of his/her disease.

2. What you need to know before your child uses Humira

Do not use Humira:

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

Warnings and precautions

Talk to your doctor or pharmacist before using Humira.

Allergic reactions

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

Infections

If your child has an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Humira. If you are unsure, contact your doctor.
Your child might get infections more easily while he/she is receiving Humira treatment. This risk may increase if your child has problems with his/her lungs. These infections may be serious and include:
tuberculosis
infections caused by viruses, fungi, parasites or bacteria
severe infection in the blood (sepsis)

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

Tell your doctor if your child lives or travels in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
Tell your doctor if your child has had infections which keep coming back or other conditions that increase the risk of infections.
Your child and his/her doctor should pay special attention to signs of infection while your child is being treated with Humira. It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Tuberculosis

As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check your child for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation including your child’s 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 child’s Patient Reminder Card.
It is very important that you tell your doctor if your child has ever had tuberculosis, or if your child has been in close contact with someone who has had tuberculosis. If your child has active tuberculosis, do not use Humira.
Tuberculosis can develop during therapy even if your child has received treatment for the prevention of tuberculosis.
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 your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV or if you think he/she might be at risk of getting HBV.
Your doctor should test your child for HBV. In people who carry HBV, Humira can cause the virus to become active again.
In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

Surgery or dental procedure

If your child is about to have surgery or dental procedures please inform your doctor that your child is taking Humira. Your doctor may recommend temporary discontinuation of Humira.

Demyelinating disease

If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Humira. Tell your doctor immediately if your child experiences symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.

Vaccinations

Certain vaccines may cause infections and should not be given while receiving Humira.
Check with your doctor before your child receives any vaccines.
It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Humira.
If your child received Humira while she was pregnant, her baby may be at higher risk for getting such an infection for up to approximately five months after the last Humira dose she received during pregnancy. It is important that you tell her baby's doctors and other health care professionals about your child’s Humira use during her pregnancy so they can decide when her baby should receive any vaccine.

Heart failure

If your child has mild heart failure and is being treated with Humira, his/her heart failure status must be closely monitored by your doctor. It is important to tell your doctor if your child has had or has a serious heart condition. If he/she develops 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 your child should receive Humira.

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 your child to stop bleeding. Your doctor may decide to stop treatment. If your child develops a fever that does not go away, develops light bruises or bleeds very easily or looks 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 Humira or other TNF blockers.
People with more serious rheumatoid arthritis that 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).
If your child takes Humira 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 Humira. Some of those patients were also treated with azathioprine or 6-mercaptopurine.
Tell your doctor if your child is taking azathioprine or 6-mercaptopurine with Humira.
Cases of non-melanoma skin cancer have been observed in patients taking Humira.
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 your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for your child.

Autoimmune disease

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

Other medicines and Humira

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

Your child should not take Humira with medicines containing the following active substances due to increased risk of serious infection:

anakinra
abatacept.

Humira can be taken together with:

methotrexate
certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations)
steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have questions, please ask your doctor.

Pregnancy and breast-feeding

Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.
Humira 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 Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
Humira can be used during breast-feeding.
If your child received Humira during her pregnancy, her baby may have a higher risk for getting an infection.
It is important that you tell her baby’s doctor and other health care professionals about her Humira use during her pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

Driving and using machines

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

3. How to use Humira

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 Humira in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Humira if your child needs a different dose.

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
Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg	20 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
Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg	20 mg every other week	Not applicable

Paediatric plaque psoriasis
Age or body weight	How much and how often to take?	Notes
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
Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg	First dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week.	Not applicable

Paediatric Crohn’s disease
Age or body weight	How much and how often to take?	Notes
Children and adolescents from 6 to 17 years of age weighing 40 kg or more	First dose of 80 mg, followed by 40 mg two weeks later. If a faster response is required, your child’s doctor may prescribe a first dose of 160 mg, followed by 80 mg two weeks later. Thereafter, the usual dose is 40 mg every other week.	Your child’s doctor may increase the dosage 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, followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every other week.	Your child’s doctor may increase the dose frequency to 20 mg every week.

Paediatric uveitis
Age or body weight	How much and how often to take?	Notes
Children and adolescents from 2 years of age weighing less than 30 kg	20 mg every other week	Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week. Humira is recommended for use in combination with methotrexate.
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. Humira is recommended for use in combination with methotrexate.

Method and route of administration

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

Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira’.

If you use more Humira than you should

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

If you forget to use Humira

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

If you stop using Humira

The decision to stop using Humira should be discussed with your doctor. Your child’s symptoms may return if you stop using Humira.

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 Humira 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 Humira.

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 (localized 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 Humira 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 your child gets 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 Humira

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

Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.

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 Humira pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, 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 throw away any medicines via wastewater or household waste. Ask your doctor or 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 Humira contains

The active substance is adalimumab.

The other ingredients are mannitol, polysorbate 80 and water for injections.

What the Humira pre-filled syringe looks like and contents of the pack

Humira 20 mg solution for injection in pre-filled syringe for paediatric use is supplied as a sterile solution of 20 mg adalimumab dissolved in 0.2 ml solution.

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

The Humira pre-filled syringe is available in a pack containing 2 pre-filled syringes with 2 alcohol pads.

Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

AbbVie Biotechnology GmbH

Knollstrasse

67061 Ludwigshafen

Germany

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

België/Belgique/Belgien

AbbVie SA

Tél/Tel: +32 10 477811

Efc^rapufl

A6Bu EOOfl

Ten.:+359 2 90 30 430

Česká republika

AbbVie s.r.o.

Tel: +420 233 098 111

Danmark

AbbVie A/S

Tlf: +45 72 30–20–28

Deutschland

AbbVie Deutschland GmbH & Co. KG

Tel: 00800 222843 33 (gebührenfrei)

Tel: +49 (0) 611 / 1720–0

Eesti

AbbVie OÜ

Tel: +372 623 1011

EXÁáóa

AbbVie OAPMAKEYTIKH A.E.

TnX: +30 214 4165 555

España

AbbVie Spain, S.L.U.

Tel: +34 91 384 09 10

France

AbbVie

Tél: +33 (0) 1 45 60 13 00

Hrvatska

AbbVie d.o.o.

Tel + 385 (0)1 5625 501

Ireland

AbbVie Limited

Tel: +353 (0)1 4287900

Ísland

Vistor hf.

Tel: +354 535 7000

Italia

AbbVie S.r.l.

Tel: +39 06 928921

Kùnpoç

Lifepharma (Z.A.M.) Ltd

Tql.: +357 22 34 74 40

Latvija

AbbVie SIA

Tel: +371 67605000

This leaflet was last revised in

Lietuva

AbbVie UAB

Tel: +370 5 205 3023

Luxembourg/Luxemburg

AbbVie SA

Belgique/Belgien

Tél/Tel: +32 10 477811

Magyarország

AbbVie Kft.

Tel.:+36 1 455 8600

Malta

V.J.Salomone Pharma Limited

Tel: +356 22983201

Nederland

AbbVie B.V.

Tel: +31 (0)88 322 2843

Norge

AbbVie AS

Tlf: +47 67 81 80 00

Österreich

AbbVie GmbH

Tel: +43 1 20589–0

Polska

AbbVie Polska Sp. z o.o.

Tel.: +48 22 372 78 00

Portugal

AbbVie, Lda.

Tel: +351 (0)21 1908400

România

AbbVie S.R.L.

Tel: +40 21 529 30 35

Slovenija

AbbVie Biofarmacevtska družba d.o.o.

Tel: +386 (1)32 08 060

Slovenská republika

AbbVie s.r.o.

Tel: +421 2 5050 0777

Suomi/Finland

AbbVie Oy

Puh/Tel: +358 (0)10 2411 200

Sverige

AbbVie AB

Tel: +46 (0)8 684 44 600

United Kingdom (Northern Ireland)

AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561090

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

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

7. Injecting Humira

The following instructions explain how to give your child a subcutaneous injection of Humira using the pre-filled syringe. First read all the instructions carefully and then follow them step by step.
You will be instructed by your doctor, nurse or pharmacist on the technique of injection.
Do not attempt to inject your child until you are sure that you understand how to prepare and give the injection.
After proper training, the injection can be given by your child or given by another person, for example, a family member or friend.
Only use each pre-filled syringe for one injection.

Humira Pre-filled Syringe

Plunger Finger Grip Needle Cover

Do not use the pre-filled syringe and call your doctor or pharmacist if the

liquid is cloudy, discoloured, or has flakes or particles in it
expiry (EXP) date has passed
liquid has been frozen or left in direct sunlight
pre-filled syringe has been dropped or crushed

Do not remove the needle cover until just before injection. Keep Humira out of the sight and reach of children.

STEP 1

Take Humira out of the refrigerator.

Leave Humira at room temperature for 15 to 30 minutes before injecting.

Do not remove the needle cover while allowing Humira to reach room temperature
Do not warm Humira in any other way. For example, do not warm it in a microwave or in hot water

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

Place the following on a clean, flat surface

1 single-use pre-filled syringe and
1 alcohol pad

Wash and dry your hands.

Choose an injection site:

On the front of your child’s thighs or
Your child’s belly (abdomen) at least 5 cm from his/her belly button (navel)
At least 3 cm from your child’s last injection site

Wipe the injection site in a circular motion with the alcohol pad.

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

Hold the pre-filled syringe in one hand.

STEP 4

Check the liquid in the pre-filled syringe.

Make sure the liquid is clear and colourless
Do not use the pre-filled syringe if the liquid is cloudy or has particles
Do not use the pre-filled syringe if it has been dropped or crushed

Gently pull the needle cover straight off with the other hand. 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.

Hold the pre-filled syringe at eye level with one

hand so you can see the air in the pre-filled syringe

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

It is normal to see a drop of liquid at the end of the needle

Insert the needle all the way into the skin at about a 45-degree angle with one quick, short motion.

After the needle is in, let go of the skin you are holding

Slowly push the plunger all the way in until all of the liquid is injected and the pre-filled syringe is empty.

When the injection is completed, slowly pull the needle out of the skin while keeping the pre-filled syringe at the same angle.

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

Do not rub
Slight bleeding at the injection site is normal

STEP 9

Throw away the used pre-filled syringe in a special disposal container as instructed by your doctor, nurse or pharmacist. Never recap a needle.

Do not recycle or throw the pre-filled syringe in the household waste
Always keep the pre-filled syringe and the special disposal container out of the sight and reach of children

The needle cover, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.

Package leaflet: Information for the patient

Humira 40 mg/0.8 ml solution for injection adalimumab

Read all of this leaflet carefully before your child starts using this medicine because it contains important information.

– 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 your child is given Humira and during treatment with Humira. Keep this Patient Reminder Card with you or your child.

– If you have any further questions, please ask your doctor or pharmacist.
– This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child's.
– If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

What is in this leaflet

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

1. What Humira is and what it is used for

Humira contains the active substance adalimumab.

Humira is intended for the treatment of the inflammatory diseases described below:

Polyarticular juvenile idiopathic arthritis
Enthesitis-related arthritis
Paediatric plaque psoriasis
Adolescent hidradenitis suppurativa
Paediatric Crohn’s disease
Paediatric ulcerative colitis
Paediatric uveitis

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

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases.

Humira is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Humira to treat his/her polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Paediatric plaque psoriasis

Humira is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom topical therapy and phototherapies have either not worked very well or are not suitable.

Adolescent 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 the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

Humira is used to treat hidradenitis suppurativa in adolescents from 12 years of age. Humira can reduce the number of nodules and abscesses you have 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 Humira.

Paediatric Crohn's disease

Crohn’s disease is an inflammatory disease of the digestive tract. Humira is indicated for the treatment of Crohn's disease in children aged 6 to 17 years. Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Humira to reduce the signs and symptoms of his/her disease.

Paediatric ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine. Humira is used to treat moderate to severe ulcerative colitis in children aged 6 to 17 years. Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Humira to reduce the signs and symptoms of his/her disease.

Paediatric uveitis

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

Humira is used to treat children from 2 years of age with chronic non-infectious uveitis 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). Humira works by reducing this inflammation.

2. What you need to know before your child uses Humira

Do not use Humira

If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in

section 6).

If your child has a severe infection, including active tuberculosis (see “Warnings and

precautions”). It is important that you tell your doctor if your child has symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.

If your child has moderate or severe heart failure. It is important to tell your doctor if your child

has had or has a serious heart condition (see “Warnings and precautions”).

Warnings and precautions

Talk to your child’s doctor or pharmacist before using Humira

If your child experiences allergic reactions with symptoms such as chest tightness, wheezing,

dizziness, swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening.

If your child has an infection, including long-term or localized infection (for example, leg ulcer)

consult your doctor before starting Humira. If you are unsure, contact your doctor.

Your child might get infections more easily while receiving Humira treatment. This risk may increase if his/her lung function is impaired. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening. It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may recommend temporary discontinuation of Humira.
As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check your child for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation including your child’s 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 child's Patient Reminder Card. It is very important that you tell your doctor if your child has ever had tuberculosis, or if he/she has been in close contact with someone who has had tuberculosis. Tuberculosis can develop during therapy even if your child has received preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Advise your doctor if your child resides or travels in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.
Advise your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.
Advise your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV or if you think he/she might be at risk of contracting HBV. Your child’s doctor should test your child for HBV. Humira can cause reactivation of HBV in people who carry this virus. In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.
If your child is about to undergo surgery or dental procedures please inform your doctor that he/she is taking Humira. Your doctor may recommend temporary discontinuation.
If your child has or develops a demyelinating disease such as multiple sclerosis, your doctor will decide if he/she should receive or continue to receive Humira. Tell your doctor immediately if your child experiences symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.
Certain vaccines may cause infections and should not be given while receiving Humira. Please check with your doctor before your child receives any vaccines. It is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy. If you received Humira 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 dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your Humira use during your pregnancy so they can decide when your baby should receive any vaccine.
If your child has mild heart failure and is being treated with Humira, his/her heart failure status must be closely monitored by your doctor. It is important to tell your doctor if your child has had or has a serious heart condition. If he/she develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of his/her feet), you must contact your doctor immediately. Your doctor will decide if your child should receive Humira.
In some patients the body may fail to produce enough of the blood cells that help your child's body fight infections or help him/her to stop bleeding. If your child develops a fever that does not go away, bruises or bleeds very easily or looks very pale, call your doctor right away. Your doctor may decide to stop treatment.
There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers. People with more serious rheumatoid arthritis that 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 leukemia (a cancer that affects the blood and bone marrow). If your child takes Humira the risk of getting lymphoma, leukemia, or other cancers may increase. On rare occasions, a specific and severe type of lymphoma, has been observed in patients taking Humira. Some of those patients were also treated with azathioprine or 6– mercaptopurine. Tell your doctor if your child is taking azathioprine or 6-mercaptopurine with Humira. In addition cases of non-melanoma skin cancer have been observed in patients taking Humira. 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 your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for your child.
On rare occasions, treatment with Humira could result in lupus-like syndrome. Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.

Other medicines and Humira

Tell your child’s doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

Humira can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).

Your child should not take Humira with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. If you have questions, please ask your doctor.

Pregnancy and breast-feeding

Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.
Humira 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 Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
Humira can be used during breast-feeding.
If your child receives Humira during her pregnancy, her baby may have a higher risk for getting

an infection.

It is important that you tell her baby’s doctor and other health care professionals about her Humira use during her pregnancy before the baby receives any vaccine. For more information on vaccines, see the “Warnings and precautions” section.

Driving and using machines

Humira may have a minor influence on the ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Humira.

Humira contains sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free’.

3. How to use Humira

Always use this medicine exactly as your child’s doctor or pharmacist has instructed. Check with your child’s doctor or pharmacist if you are not sure about any of the instructions or if you have any questions.

Your doctor may prescribe another strength of Humira if your child needs a different dose.

Children and adolescents with polyarticular juvenile idiopathic arthritis

Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg

The recommended dose of Humira is 20 mg every other week.

Children and adolescents from 2 years of age weighing 30 kg or more

The recommended dose of Humira is 40 mg every other week.

Children, adolescents and adults with enthesitis-related arthritis

Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg

The recommended dose of Humira is 20 mg every other week.

Children, adolescents and adults from 6 years of age weighing 30kg or more

The recommended dose of Humira is 40 mg every other week.

Children and adolescents with psoriasis

Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg

The recommended dose of Humira is an initial dose of 20 mg, followed by 20 mg one week later.

Thereafter, the usual dose is 20 mg every other week.

Children and adolescents from 4 to 17 years of age weighing 30 kg or more

The recommended dose of Humira is an initial dose of 40 mg, followed by 40 mg one week later.

Thereafter, the usual dose is 40 mg every other week.

Adolescents with hidradenitis suppurativa from 12 to 17 years of age, weighing 30 kg or more

The recommended dose of Humira is an initial dose of 80 mg (as 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 Humira 40 mg every other week, your doctor may increase the dosage 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.

Children and adolescents with Crohn's disease

Children and adolescents from 6 to 17 years of age weighing less than 40 kg

The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your child’s doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg two weeks later.

Thereafter, the usual dose is 20 mg every other week. Depending on your child’s response, your child’s doctor may increase the dose frequency to 20 mg every week.

Children and adolescents from 6 to 17 years of age weighing 40 kg or more

The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later. If a faster response is required, your child’s doctor may prescribe an initial dose of 160 mg initially (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 40 mg every other week. Depending on your child’s response, your child’s doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Children and adolescents with ulcerative colitis

Children and adolescents from 6 years of age weighing less than 40 kg

The usual Humira dose is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg (as one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.

Patients who turn 18 years of age while on 40 mg every other week, should continue their prescribed dose.

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

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

Patients who turn 18 years of age while on 80 mg every other week, should continue their prescribed dose.

Children and adolescents with chronic non-infectious uveitis from 2 years of age

Children and adolescents from 2 years of age weighing less than 30 kg

The usual dose of Humira is 20 mg every other week with methotrexate.

Your child’s doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.

Children and adolescents from 2 years of age weighing 30 kg or more

The usual dose of Humira is 40 mg every other week with methotrexate.

Your child’s doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.

Method and route of administration

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

Instructions for preparing and giving an injection of Humira

The following instructions explain how to inject Humira. Please read the instructions carefully and follow them step by step. You will be instructed by your child's doctor or his/her assistant on the technique of injection and the amount to give to your child. Do not attempt to give your child an injection until you are sure that you understand how to prepare and give the injection. After proper training, the injection can be self-administered or given by another person, for example a family member or friend.

Failure to perform the following steps as described may cause contamination which may lead to infection of your child.

This injection should not be mixed in the same syringe or vial with any other medicine.

1) Setting up

Make sure you know the proper amount (volume) needed for dosing. If you don’t know the amount, STOP HERE and contact your doctor for further instruction.
You will need a special container for waste, such as a sharps container or as instructed by your

nurse, doctor or pharmacist. Place the container on your work surface.

Wash your hands thoroughly
Remove one box containing, one syringe, one vial adapter, one vial, two alcohol pads and one

needle from the carton. If there is a second box in the carton for a future injection, place it back in the refrigerator immediately.

Look at the expiry date on the box to be used. DO NOT use any item after the date shown on the

box.

Set up the following items on a clean surface, DO NOT take them out of their individual packaging

yet.

o One 1 ml syringe (1)

o One vial adapter (2)

o One vial for paediatric use of Humira for injection (3)

o Two alcohol pads (4)

o One needle (5)

Humira is a liquid that is clear and colourless. DO NOT use if the liquid is cloudy, discoloured or

has flakes or particles in it.

2) Preparing the Humira dose for injection

General handling: DO NOT dispose of any waste items until after the injection is completed.

Prepare the needle by partially peeling the package open from the end closest to the yellow syringe connector. Peel the package just far enough to expose the yellow syringe connector.

Set the package down with the clear side of the package facing up.

Pop off the white plastic cap from the vial to see the top of the vial stopper.
Use one of the alcohol pads to wipe the vial stopper. DO NOT touch the vial stopper after wiping with the alcohol pad.
Peel the cover off the vial adapter package but do not take out the vial adapter.
Hold the vial with the vial stopper facing up.
With the vial adapter still in the clear package, attach it to the vial stopper by pushing down until the vial adapter snaps in place.
When you are sure the adapter is attached to the vial, lift off the package from the vial adapter.

Gently set the vial with vial adapter down on your clean work surface. Be careful that it does not fall over. DO NOT touch the vial adapter.
Prepare the syringe by partially peeling the package open from the end closest to white plunger rod.
Peel the clear package just far enough to expose the white plunger rod, but do not take the syringe

out of the package.

Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml). NEVER pull past the 0.9 ml position regardless of prescribed dose.
You will set the volume to the prescribed dose in a later step.
DO NOT pull the white plunger rod completely out of the syringe.

NOTE :

If the white plunger rod is pulled completely out of the syringe, discard the syringe and contact your Humira provider for a replacement. DO NOT try to reinsert the white plunger rod.

Dose + 0.1 ml

DO NOT use the white plunger rod to remove the syringe from the package. Hold the syringe on

the graduated area and pull the syringe from its package. DO NOT set the syringe down at any time.

While holding the vial adapter firmly, insert the syringe tip into the vial adapter and twist the

syringe clockwise with one hand until firm. DO NOT over-tighten.

While holding the vial, push the white plunger rod all the way down. This step is important to get the proper dose. Hold the white plunger rod in and turn the vial and syringe upside down.
SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose. This is important to get the proper dose. You will set the volume to the prescribed dose in step 4, Dose Preparation. If the prescribed dose is 0.5 ml, pull the white plunger rod out to 0.6 ml. You will see the liquid medication from the vial go into the syringe.
Push the white plunger rod all the way back in to push the liquid medication back into the vial.

Again, SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose, this is important to get the proper dose and important in order to prevent air bubbles or air gaps in the liquid medication. You will set the volume to the prescribed dose in step 4, Dose Preparation.

If you see remaining air bubbles or air gaps in the liquid medication in the syringe, you may repeat this process up to 3 times. DO NOT shake the syringe.

NOTE :

If the white plunger rod is pulled completely out of the syringe, discard the syringe and contact your Humira provider for a replacement. DO NOT try to reinsert the white plunger rod.

While still holding the syringe upright at the graduated area, remove the vial adapter with the vial by twisting the vial adapter off with the other hand. Be sure to remove the vial adapter with the vial from the syringe. DO NOT touch the tip of the syringe.
If a large air bubble or air gap can be seen near the syringe tip, SLOWLY push the white plunger rod into the syringe until fluid begins to enter the syringe tip. DO NOT push the white plunger rod past the dose position.
For example, if the prescribed dose is 0.5 ml, DO NOT push the white plunger rod past the 0.5 ml position.
Check to see that the fluid remaining in the syringe is at least the prescribed dose volume. If the remaining volume is less than the prescribed dose volume, DO NOT use the syringe and contact your healthcare provider.
With your free hand, pick up the needle package with the yellow syringe connector facing down.
Keeping the syringe up, insert the syringe tip into the yellow syringe connector and twist the syringe

as indicated by the arrow in the picture until firm. The needle is now attached to the syringe.

Pull the needle package off, but DO NOT remove the clear needle cap.
Place the syringe on your clean work surface. Continue with injection site and dose preparation immediately.
3) Choosing and preparing an injection site

Choose a site on your thigh or stomach. DO NOT use the same site that was used for the last injection.
The new injection site should be given at least 3 cm from the last injection site.
DO NOT inject in an area where the skin is reddened, bruised, or hard. This may mean there is an infection and therefore you should contact your doctor.
To reduce the chance of infection, wipe the injection site with the other alcohol pad. DO NOT touch the area again before injecting.

4) Dose Preparation

Pick up the syringe with the needle pointing up.
Use your other hand to flip the pink needle cover down toward the syringe.
Remove the clear needle cap by pulling it straight up with your other hand.
The needle is clean.
DO NOT touch the needle.
DO NOT set the syringe down at any time after the clear needle cap is off.
DO NOT try to put the clear needle cap back on the needle.
Hold the syringe at eye-level with the needle pointing up to see the amount clearly. Be careful not

to squirt the liquid medication into your eye.

Recheck the prescribed medication amount.
Push the white plunger rod gently into the syringe until the syringe contains the prescribed amount

of liquid. Excess liquid may come out of the needle while the white plunger rod is being pushed. DO NOT wipe off the needle or the syringe.

5) Injecting Humira

With the free hand, gently grasp the cleaned area of skin and hold firmly.
With the other hand, hold syringe at 45-degree angle to skin.
With one quick, short motion, push needle all the way into skin.
Let go of the skin in your hand.
Push the white plunger rod to inject the liquid medication until the syringe is empty.
When the syringe is empty, remove the needle from skin, being careful to pull it out at the same

angle as when it was inserted.

Gently flip the pink needle cover up, over the needle and snap into place and set the syringe with

needle on the work surface. DO NOT put the clear needle cap back on the needle.

Using a piece of gauze, apply pressure over the injection site for 10 seconds. A little bleeding may

occur. DO NOT rub the injection site. Use a plaster if you want to.

6) Throwing away supplies

You will need a special container for waste, such as a sharps container or as instructed by your nurse,

doctor or pharmacist.

Put the syringe with needle, vial and vial adapter into a special sharps container. DO NOT put these

items into regular household waste.

The syringe, needle, vial and vial adapter MUST NEVER be reused.
Keep the special container out of the sight and reach of children at all times.
Throw away all other used items into your regular household waste.

If you use more Humira than you should

If you accidentally inject a larger amount of Humira liquid, or if you inject Humira more frequently than told to by your doctor, call your doctor and tell him/her that your child has taken more. Always take the outer carton or the vial of the medicine with you, even if it is empty.

If you use less Humira than you should

If you accidentally inject a smaller amount of Humira liquid, or if you inject Humira less frequently than told to by your child’s doctor or pharmacist, you should call your child’s doctor or pharmacist and tell him/her that your child has taken less. Always take the outer carton or the vial of the medicine with you, even if it is empty.

If you forget to use Humira

If you forget to give your child a Humira injection, you should inject the Humira dose as soon as you remember. Then administer your child's next dose as you would have on the originally scheduled day, had you not forgotten a dose.

If your child stops using Humira

The decision to stop using Humira should be discussed with your child’s doctor. Your child’s symptoms may return upon discontinuation.

If you have any further questions on the use of this product, 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 exertion 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 Humira.

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;
sensation of heart beating rapidly;
high blood pressure;
flushing;
haematoma;
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;
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;
stroke;
neuropathy;
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 on the pleural space);
inflammation of the pancreas which causes severe pain in the abdomen and back;
difficulty in swallowing;
facial oedema;
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 1000 people)

leukemia (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;
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 associated with allergic reactions;
erythema multiforme (inflammatory skin rash);
lupus-like syndrome;
angioedema (localized swelling of the skin);
lichenoid skin reaction (itchy reddish-purple skin rash).

Not known (frequency cannot be estimated from 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 Humira 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 your child gets any side effects, talk to your child’s 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 Humira

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

Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.

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

Keep the vial in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your doctor or 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 Humira contains

The active substance is adalimumab.

The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.

What the Humira vial looks like and contents of the pack

Humira 40 mg solution for injection in vials is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.

The Humira vial is a glass vial containing a solution of adalimumab. One pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle, 1 vial adapter and 2 alcohol pads.

Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

AbbVie Biotechnology GmbH

Knollstrasse

67061 Ludwigshafen

Germany

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

Belgie/Belgique/Belgien

AbbVie SA

Tél/Tel: +32 10 477811

Efc^rapufl

A6Bu EOOfl

Ten.:+359 2 90 30 430

Lietuva

AbbVie UAB

Tel: +370 5 205 3023

Luxembourg/Luxemburg

AbbVie SA Belgique/Belgien

Česká republika

AbbVie s.r.o.

Tel: +420 233 098 111

Danmark

AbbVie A/S

Tlf: +45 72 30–20–28

Deutschland

AbbVie Deutschland GmbH & Co. KG

Tel: 00800 222843 33 (gebührenfrei)

Tel/Tel: +32 10 477811

Magyarorszag

AbbVie Kft.

Tel.:+36 1 455 8600

Malta

V.J.Salomone Pharma Limited

Tel: +356 22983201

Nederland

AbbVie B.V.

Tel: +31 (0)88 322 2843

Tel: +49 (0) 611 / 1720–0

Eesti

AbbVie OÜ

Tel: +372 623 1011

EZZáSa

AbbVie OAPMAKEYTIKH A.E.

Tql: +30 214 4165 555

España

AbbVie Spain, S.L.U.

Tel: +34 91 384 09 10

France

AbbVie

Tél: +33 (0) 1 45 60 13 00

Hrvatska

AbbVie d.o.o.

Tel + 385 (0)1 5625 501

Ireland

AbbVie Limited

Tel: +353 (0)1 4287900

Ísland

Vistor hf.

Tel: +354 535 7000

Italia

AbbVie S.r.l.

Tel: +39 06 928921

Norge

AbbVie AS

Tlf: +47 67 81 80 00

Österreich

AbbVie GmbH

Tel: +43 1 20589–0

Polska

AbbVie Polska Sp. z o.o.

Tel.: +48 22 372 78 00

Portugal

AbbVie, Lda.

Tel: +351 (0)21 1908400

Romania

AbbVie S.R.L.

Tel: +40 21 529 30 35

Slovenija

AbbVie Biofarmacevtska družba d.o.o.

Tel: +386 (1)32 08 060

Slovenská republika

AbbVie s.r.o.

Tel: +421 2 5050 0777

Suomi/Finland

AbbVie Oy

Puh/Tel: +358 (0)10 2411 200

Kvnpog

Lifepharma (Z.A.M.) Ltd

Tq!.: +357 22 34 74 40

Latvija

AbbVie SIA

Tel: +371 67605000

This leaflet was last revised in

Sverige

AbbVie AB

Tel: +46 (0)8 684 44 600

United Kingdom (Northern Ireland)

AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561090

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

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

Package leaflet: Information for the patient

Humira 40 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 are given Humira and during treatment with Humira. Keep this Patient Reminder Card with you.

– If you have any further questions, please 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 Humira is and what it is used for
2. What you need to know before you use Humira
3. How to use Humira
4. Possible side effects
5 How to store Humira
6. Contents of the pack and other information

1. What Humira is and what it is used for

Humira contains the active substance adalimumab.

Humira is intended for the treatment of the inflammatory diseases described below:

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

The active ingredient in Humira, 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.

Humira is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, 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 Humira to treat your rheumatoid arthritis.

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

Humira has been shown to slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.

Usually, Humira is used with methotrexate. If your doctor determines that methotrexate is inappropriate, Humira can be given alone.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases.

Humira is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years. 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 Humira to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

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.

Humira is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira to reduce the signs and symptoms of your disease.

Psoriatic arthritis

Psoriatic arthritis is an inflammation of the joints associated with psoriasis.

Humira is used to treat psoriatic arthritis in adults. Humira has been shown to slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.

Plaque psoriasis in adults and children

Humira is used to treat moderate to severe plaque psoriasis in adults. Humira is also used to treat severe 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 in adults and adolescents

Humira is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. Humira can reduce the number of nodules and abscesses you have 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 Humira.

Crohn’s disease in adults and children

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

Humira is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira to reduce the signs and symptoms of your Crohn’s disease.

Ulcerative colitis in adults and children

Ulcerative colitis is an inflammatory disease of the large intestine.

Humira is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis you may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira to reduce the signs and symptoms of your disease.

Non-infectious uveitis in adults and children

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

Humira is used to treat

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

2. What you need to know before you use Humira

Do not use Humira

If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
If you have a severe infection, including active tuberculosis (see Warnings and precautions”). It is

important that you tell your doctor if you have symptoms of infections, e.g. 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 Humira

If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness,

swelling or rash do not inject more Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening.

If you have an infection, including long-term or localized infection (for example, leg ulcer)

consult your doctor before starting Humira. If you are unsure, contact your doctor.

You might get infections more easily while you are receiving Humira treatment. This risk may increase if your lung function is impaired. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, 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 recommend temporary discontinuation of Humira.
As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check you for signs and symptoms of tuberculosis before starting Humira. 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. 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. Tuberculosis can develop during therapy even if you have received preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.
Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Advise 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 contracting HBV. Your doctor should test you for HBV. Humira can cause reactivation of HBV in people who carry this virus. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
If you are over 65 years you may be more susceptible to infections while taking Humira. You and

your doctor should pay special attention to signs of infection while you are being treated with Humira. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

If you are about to undergo surgery or dental procedures, please inform your doctor that you are taking Humira. Your doctor may recommend temporary discontinuation of Humira.
If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive Humira. 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.
Certain vaccines may cause infections and should not be given while receiving Humira. Please check with your doctor before you receive any vaccines. It is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy. If you received Humira 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 dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your Humira use during your pregnancy so they can decide when your baby should receive any vaccine.
If you have mild heart failure and you are being treated with Humira, 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 Humira.
In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.
There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers. People with more serious rheumatoid arthritis that 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 leukemia (a cancer that affects the blood and bone marrow). If you take Humira the risk of getting lymphoma, leukemia, or other cancers may increase. On rare occasions, a specific and severe type of lymphoma has been observed in patients taking Humira. Some of those patients were also treated with azathioprine or 6– mercaptopurine. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira. In addition, cases of nonmelanoma skin cancer have been observed in patients taking Humira. 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.
On rare occasions, treatment with Humira 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 Humira.
Do not give Humira to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.

Other medicines and Humira

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

You should not take Humira with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. 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 Humira 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.
Humira 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 Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
Humira can be used during breast-feeding
If you receive Humira 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 Humira 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

Humira may have a minor influence on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Humira.

Humira contains sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free’.

3. How to use Humira

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor may prescribe another strength of Humira if you need a different dose.

Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Humira is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.

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

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

Children, adolescents and adults with polyarticular juvenile idiopathic arthritis

Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg

The recommended dose of Humira is 20 mg every other week.

Children, adolescents and adults from 2 years of age weighing 30kg or more

The recommended dose of Humira is 40 mg every other week.

Children, adolescents and adults with enthesitis-related arthritis

Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg

The recommended dose of Humira is 20 mg every other week.

Children, adolescents and adults from 6 years of age weighing 30kg or more

The recommended dose of Humira is 40 mg every other week.

Adults with psoriasis

The usual dose for adults with psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject Humira for as long as your doctor has told you. Depending on your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Children and adolescents with plaque psoriasis

Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg

The recommended dose of Humira is an initial dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week.

Children and adolescents from 4 to 17 years of age weighing 30 kg or more

The recommended dose of Humira is an initial dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.

Adults with hidradenitis suppurativa

The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as 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 with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more

It is recommended that you use an antiseptic wash daily on the affected areas.

Adults with Crohn’s disease

The usual dose regimen for Crohn’s disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week two weeks later. If a faster response is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later and thereafter as 40 mg every other week. Depending on your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Children and adolescents with Crohn's disease

Children and adolescents from 6 to 17 years of age weighing less than 40 kg

The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg two weeks later.

Thereafter, the usual dose is 20 mg every other week. Depending on your response, your doctor may increase the dose frequency to 20 mg every week.

Children and adolescents from 6 to 17 years of age weighing 40 kg or more

The usual dose regimen is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg two weeks later. If a faster response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.

Thereafter, the usual dose is 40 mg every other week. Depending on your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Adults with ulcerative colitis

The usual Humira dose for adults with ulcerative colitis is 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) at Week 0 and 80 mg (as two 40 mg injections in one day) at Week 2 and thereafter 40 mg every other week. Depending on your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Children and adolescents with ulcerative colitis

Children and adolescents from 6 years of age weighing less than 40 kg

The usual Humira dose is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg (as one 40 mg injection) two weeks later. Thereafter, the usual dose is 40 mg every other week.

Patients who turn 18 years of age while on 40 mg every other week, should continue their prescribed dose.

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

Patients who turn 18 years of age while on 80 mg every other week, should continue their prescribed dose.

Adults with non-infectious uveitis

The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two injections in one day), followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject Humira for as long as your doctor has told you.

In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Humira. Humira can also be given alone.

Children and adolescents with chronic non-infectious uveitis from 2 years of age

Children and adolescents from 2 years of age weighing less than 30 kg

The usual dose of Humira is 20 mg every other week with methotrexate.

Your doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.

Children and adolescents from 2 years of age weighing 30 kg or more

The usual dose of Humira is 40 mg every other week with methotrexate.

Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.

Method and route of administration

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

Instructions for preparing and giving an injection of Humira

The following instructions explain how to inject Humira. Please read the instructions carefully and follow them step by step. You will be instructed by your doctor or his/her assistant on the technique of selfinjection. Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection. After proper training, the injection can be self-administered or given by another person, for example a family member or friend.

This injection should not be mixed in the same syringe or vial with any other medicine.

1) Setting up

Wash your hands thoroughly

Set up the following items on a clean surface

o One pre-filled syringe of Humira for injection o One alcohol pad

Look at the expiry date on the syringe. Do not use the product after the month and year shown.

2) Choosing and preparing an injection site

Choose a site on your thigh or stomach

Each new injection should be given at least 3 cm from the last injection site.

o Do not inject in an area where the skin is reddened, bruised, or hard. This may mean there is an infection.

o Wipe the injection site with the enclosed alcohol pad, using a circular motion.

o Do not touch the area again before injecting.

3) Injecting Humira

Do NOT shake the syringe.
Remove cap from needle syringe, being careful not to touch the needle or let it touch any surface.
With one hand, gently grasp the cleaned areas of skin and hold firmly
With the other hand, hold syringe at 45-degree angle to skin, with the grooved side up.
With one quick, short motion, push needle all the way into skin
Release the skin with the first hand
Push plunger to inject solution – it can take from 2 to 5 seconds to empty the syringe
When the syringe is empty, remove the needle from skin, being careful to keep it at the same angle as when it was inserted
Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds. A little bleeding may occur. Do not rub the injection site. Use a plaster if you want to.

4) Throwing away supplies

The Humira syringe should NEVER be reused. NEVER recap a needle.
After injecting Humira, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Keep this container out of the sight and reach of children

Instructions for preparing and giving an injection of Humira

This injection should not be mixed in the same syringe or vial with any other medicine.

1) Setting up

Wash your hands thoroughly

Set up the following items on a clean surface

o One pre-filled syringe of Humira for injection

o One alcohol pad

Look at the expiry date on the syringe. Do not use the product after the month and year shown.

2) Choosing and preparing an injection site

Choose a site on your thigh or stomach

Each new injection should be given at least 3 cm from the last injection site.

o Do not inject in an area where the skin is reddened, bruised, or hard. This may mean there is an infection.

o Wipe the injection site with the enclosed alcohol pad, using a circular motion.

o Do not touch the area again before injecting.

3) Injecting Humira

Do NOT shake the syringe.
Remove cap from needle syringe, being careful not to touch the needle or let it touch any surface.
With one hand, gently grasp the cleaned areas of skin and hold firmly
With the other hand, hold syringe at 45-degree angle to skin, with the grooved side up.
With one quick, short motion, push needle all the way into skin

Release the skin with the first hand
Push plunger to inject solution – it can take from 2 to 5 seconds to empty the syringe
When the syringe is empty, remove the needle from skin, being careful to keep it at the same angle as when it was inserted
Hold the syringe in one hand and with the other hand slide the outer protective shield over the

exposed needle until it locks in place

Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds. A little bleeding may occur. Do not rub the injection site. Use a plaster if you want to.

4) Throwing away supplies

The Humira syringe should NEVER be reused. NEVER recap a needle
After injecting Humira, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.

Keep this container out of the sight and reach of children

If you use more Humira than you should

If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell him/her 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 Humira

If you forget to give yourself an injection, you should inject the next dose of Humira 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 Humira

The decision to stop using Humira should be discussed with your doctor. Your symptoms may return upon discontinuation.

If you have any further questions on the use of this product, 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 exertion 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 Humira.

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;
sensation of heart beating rapidly;
high blood pressure;
flushing;
haematoma;
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;
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;
neuropathy;
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;
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;
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 associated with allergic reactions;
erythema multiforme (inflammatory skin rash);
lupus-like syndrome;
angioedema (localized swelling of the skin);
lichenoid skin reaction (itchy reddish-purple skin rash).

Not known (frequency cannot be estimated from 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 Humira 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 Humira

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

Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.

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 Humira pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, 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 throw away any medicines via wastewater or household waste. Ask your doctor or 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 Humira contains

The active substance is adalimumab.

What the Humira pre-filled syringe looks like and contents of the pack

Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.

The Humira pre-filled syringe is a glass syringe containing a solution of adalimumab. Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 1, 2, 4 or 6 alcohol pads, respectively.

Not all pack sizes may be marketed.

Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

AbbVie Biotechnology GmbH

Knollstrasse

67061 Ludwigshafen

Germany

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

Belgie/Belgique/Belgien	Lietuva
AbbVie SA	AbbVie UAB
Tel/Tel: +32 10 477811	Tel: +370 5 205 3023
Efc^rapufl	Luxembourg/Luxemburg
A6Bu EOOfl	AbbVie SA
Ten.:+359 2 90 30 430	Belgique/Belgien Tel/Tel: +32 10 477811
Ceska republika	Magyarorszag
AbbVie s.r.o.	AbbVie Kft.
Tel: +420 233 098 111	Tel.:+36 1 455 8600

Danmark

AbbVie A/S

Tlf: +45 72 30–20–28

Deutschland

AbbVie Deutschland GmbH & Co. KG

Tel: 00800 222843 33 (gebührenfrei)

Tel: +49 (0) 611 / 1720–0

Eesti

AbbVie OÜ

Tel: +372 623 1011

EMáSa

AbbVie OAPMAKEYTIKH A.E.

Tql: +30 214 4165 555

España

AbbVie Spain, S.L.U.

Tel: +34 91 384 09 10

France

AbbVie

Tél: +33 (0) 1 45 60 13 00

Hrvatska

AbbVie d.o.o.

Tel + 385 (0)1 5625 501

Ireland

AbbVie Limited

Tel: +353 (0)1 4287900

Ísland

Vistor hf.

Tel: +354 535 7000

Italia

AbbVie S.r.l.

Tel: +39 06 928921

Kúnpog

Lifepharma (Z.A.M.) Ltd

Tq!.: +357 22 34 74 40

Latvija

AbbVie SIA

Tel: +371 67605000

This leaflet was last revised in

Malta

V.J.Salomone Pharma Limited

Tel: +356 22983201

Nederland

AbbVie B.V.

Tel: +31 (0)88 322 2843

Norge

AbbVie AS

Tlf: +47 67 81 80 00

Österreich

AbbVie GmbH

Tel: +43 1 20589–0

Polska

AbbVie Polska Sp. z o.o.

Tel.: +48 22 372 78 00

Portugal

AbbVie, Lda.

Tel: +351 (0)21 1908400

Romania

AbbVie S.R.L.

Tel: +40 21 529 30 35

Slovenija

AbbVie Biofarmacevtska družba d.o.o.

Tel: +386 (1)32 08 060

Slovenská republika

AbbVie s.r.o.

Tel: +421 2 5050 0777

Suomi/Finland

AbbVie Oy

Puh/Tel: +358 (0)10 2411 200

Sverige

AbbVie AB

Tel: +46 (0)8 684 44 600

United Kingdom (Northern Ireland)

AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561090

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

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

Package leaflet: Information for the patient

Humira 40 mg solution for injection in pre-filled pen 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 are given Humira and during treatment with Humira. Keep this Patient Reminder Card with you.

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

1. What Humira is and what it is used for

Humira contains the active substance adalimumab.

Humira is intended for the treatment of the inflammatory diseases described below:

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