Hyrimoz® 20 mg/0.2ml – patient leaflet, side effects, dosage

What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that

acts on your body’s immune (defence) system.

Hyrimoz is intended for the treatment of the following inflammatory

diseases:

• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis
• paediatric plaque psoriasis,
• paediatric Crohn’s disease,

• paediatric non-infectious uveitis.

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

  The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Hyrimoz blocks its action and reduces the inflammation in these diseases.

  Polyarticular juvenile idiopathic arthritis

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

  Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years. Patients may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, patients will be given Hyrimoz to treat their polyarticular juvenile idiopathic arthritis.

  Enthesitis-related arthritis

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

  Hyrimoz is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years.

  Patients may first be given other disease-modifying medicines, such as methotrexate.

  If these medicines do not work well enough, patients will be given Hyrimoz to treat their enthesitis-related arthritis.

  Plaque psoriasis is an inflammatory 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.

  Hyrimoz is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.

  Paediatric Crohn’s disease

  Crohn’s disease is an inflammatory disease of the gut.

  Hyrimoz 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 Hyrimoz to reduce the signs and symptoms of his / her disease.

  Paediatric non-infectious uveitis

  Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. The inflammation leads 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). Hyrimoz works by reducing this inflammation.

  Hyrimoz is used to treat children from 2 years of age with chronic non-infectious uveitis 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 Hyrimoz to reduce the signs and symptoms of his / her disease.

What you need to know before your child uses Hyrimoz

Do not use Hyrimoz

• 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 tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system). It is important that you tell your doctor if your child shows symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).

• 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 Hyrimoz.

  Allergic reaction

  • If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Hyrimoz 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 or localised infection (for example leg ulcer), consult your doctor before starting Hyrimoz. If you are unsure, contact your doctor.
• Your child might get infections more easily while he / she is receiving Hyrimoz treatment. This risk may increase if your child’s lung function is reduced. These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
• In rare cases, these infections may be life-threatening. It is important to tell your doctor if your child shows symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may recommend temporarily stopping Hyrimoz.

Tuberculosis (TB)

• As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check your child for signs and symptoms of tuberculosis before starting Hyrimoz. This will include a thorough medical evaluation including your child’s medical history and 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 had preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Travel / recurrent infection

• Tell your doctor if your child has lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are very common.
• Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.

Hepatitis B virus

• Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he / she has active HBV infection or if you think he / she might be at risk of getting HBV. Your doctor should test your child for HBV. Adalimumab can reactivate HBV infection 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 infection can be life-threatening.

Surgery or dental procedures

• If your child is about to have surgery or dental procedures tell your doctor that your child is taking Hyrimoz. Your doctor may recommend

  temporarily stopping Hyrimoz.

  Demyelinating disease

  • If your child has or develops 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 Hyrimoz. Tell your doctor immediately if he / she experiences symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.

Vaccine

• Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Hyrimoz in case they cause infections. Check with your doctor before your child receives any vaccines. It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hyrimoz.

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

Heart failure

• It is important to tell your doctor if your child has had or has a serious heart condition. If your child has mild heart failure and is being treated with Hyrimoz, the heart failure status must be closely monitored by your doctor. If your child develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.

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 stop bleeding. If your child develops a fever that does not go away, or he / she bruises or bleeds very easily or looks very pale, call your doctor right away. Your doctor may decide to stop treatment.

Cancer

• There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers. People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow). If your child takes Hyrimoz, the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, a specific and severe type of lymphoma has been observed in patients taking adalimumab. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your doctor if your child is taking azathioprine or mercaptopurine with Hyrimoz.
• In addition cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage 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 TNFα blocker. If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate.

  Autoimmune diseases

  • On rare occasions, treatment with Hyrimoz 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

• Do not give Hyrimoz to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
• Do not give Hyrimoz to children with paediatric plaque psoriasis or paediatric ulcerative colitis below the age of 4 years.
• Do not give Hyrimoz to children with paediatric Crohn’s disease below the age of 6 years.
• Do not use the 40 mg pre-filled syringe if doses lower than 40 mg are recommended.

Other medicines and Hyrimoz

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

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

Your child should not take Hyrimoz with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions. 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 Hyrimoz treatment.
• If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice before taking this medicine.
• Hyrimoz should only be used during a pregnancy if needed.
• According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
• Hyrimoz can be used during breast-feeding.
• If your child receives Hyrimoz during her pregnancy, the baby may have a higher risk for getting an infection.
• It is important that you tell her baby’s doctors and other health care professionals about her Hyrimoz 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

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

Hyrimoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.2 ml dose, that is to say essentially ‘sodium-free’.

How to use Hyrimoz

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 Hyrimoz in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Hyrimoz if your child needs 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, 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, adolescents from

6 years of age weighing 15 kg to less than 30 kg

20 mg every other week

Not applicable

Instructions for use

To help avoid possible infections and to ensure that you use the

medicine correctly, it is important that you follow these instructions.

Be sure that you read, understand, and follow these Instructions for

Use before injecting Hyrimoz. Your healthcare provider should show

you how to prepare and inject Hyrimoz properly using the single-

dose pre-filled syringe before you use it for the first time. Talk to your

healthcare provider if you have any questions.

Your Hyrimoz single-use pre-filled syringe

Figure A: Hyrimoz pre-filled syringe

It is important that you:

• do not use the pre-filled syringe if the seal of the outer carton is

  broken, as it may not be safe to use.

• do not open the inner carton until you are ready to use the

  Hyrimoz pre-filled syringe.

  • never leave the pre-filled syringe unattended where others might tamper with it.
  • if you drop your syringe, do not use it if it looks damaged, or if you dropped it with the needle cap removed.
  • do not remove the needle cap until just before you give the injection.
  • Inject Hyrimoz 15–30 minutes after taking it out of the refrigerator for a more comfortable injection.
  • throw away the used syringe right away after use. Do not re-use a syringe. See “4. Disposing of used syringes” at the end of these Instructions for Use.
  • consult your healthcare provider or nurse for advise on appropriate injection site and injection technique if you are underweight or if you are injecting a child.

How should you store Hyrimoz single-dose pre-filled syringe?

• Store the Hyrimoz pre-filled syringe in the original carton to protect from light.
• Store your outer carton of pre-filled syringes in a refrigerator, between 2°C to 8°C.
• If needed (for example if you are travelling), you may store the pre-filled syringe at room temperature up to 25°C for up to 42 days.
• Throw away the pre-filled syringe that has been stored at room temperature after 42 days.
• You should record the date when your pre-filled syringe is first removed from the refrigerator, and the date after which it should be discarded.
• Do not store your pre-filled syringe in extreme heat or cold.
• Do not freeze your pre-filled syringe.
• Do not use your pre-filled syringe after the expiration date shown on the outer carton or syringe label. If it has expired, return the entire pack to the pharmacy.

Keep Hyrimoz and all medicines out of the reach of children.

What do you need for your injection?

Place the following items on a clean, flat surface.

Included in your pre-filled syringe carton is:

• Hyrimoz pre-filled syringe (see Figure A). Each pre-filled syringe contains 20 mg/0.2 ml of adalimumab.

  Not included in your Hyrimoz pre-filled syringe carton are (see Figure B):

• Alcohol wipe

• Cotton ball or gauze
• Sharps disposal container; See “4. Disposing of used syringes” at the end of these Instructions for Use.

• Adhesive bandage

  Figure B: items not included in the carton

Preparing the pre-filled syringe

• For a more comfortable injection, take the carton containing the pre- filled syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes so that it reaches room temperature.
• Remove the pre-filled syringe out of the carton box and inspect it. The solution should be colourless or slightly yellowish as well as clear to slightly opalescent. Do not use if any particulates and / or discolorations are observed. If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.

• Do not use the pre-filled syringe if it is broken. Return the entire product pack to the pharmacy.

  • Look at the expiration date (EXP) on your pre-filled syringe. Do not use your pre-filled syringe if the expiration date has passed. Contact your pharmacist if the pre-filled syringe fails any of the above mentioned checks.
  • Choosing your injection site:

The injection site is the place on the body where you are going to inject the Hyrimoz pre-filled syringe.

• The recommended injection site is the front of the thighs. You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure C).
• Choose a different site each time you give an injection.
• Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.

• If you have psoriasis, you should not inject directly into areas with psoriasis plaques.

  Figure C: choose your injection site

• Cleaning your injection site:
• When you are ready to use the pre-filled syringe, wash your hands thoroughly with soap and water.
• Using a circular motion, clean the injection site with an alcohol wipe. Let it dry before injecting (see Figure D).

• Do not touch this area again before giving the injection. Allow the skin to dry before injecting. Do not fan or blow on the clean area.

  Figure D: clean your injection site

  1. 3. Giving your injection:
  2. • Carefully pull the needle cap straight off to remove it from the syringe (see Figure E).
  3. • Throw away (discard) the needle cap.
  4. •

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

     Figure E: pull the needle cap off

     • Gently pinch the skin at the injection site (see Figure F).

     • Insert the needle into the skin at a 45° degree angle, as shown (see Figure F).

       Figure F: insert the needle

     • Hold the single-dose pre-filled syringe as shown (see Figure G).
     • Slowly press down on the plunger as far as it will go.
     • Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.

     • Carefully lift the needle straight out from the injection site and let go of the skin. There may be a small amount of blood at the injection site. You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.

       Figure G: press down the plunger

       1. 4. Disposing of used pre-filled syringes:
       2. • Dispose of the used syringe in a sharps container (closable, puncture resistant container). For the safety and health of you and others, needles and used syringes must never be re-used.
       3. •

          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. Any unused product or waste material should be disposed of in accordance with local requirements.

          Figure H: dispose of the used Pre-filled syringe

If you have any questions, please talk to a doctor, pharmacist or nurse who is familiar with Hyrimoz.

Continued on the next page >> adalimumab

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

adolescent 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 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.

If this dose does not work well enough, 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 every other week

starting two

weeks later.

If a faster

response is

required, your 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.

If this dose does not work well enough, your child’s doctor may increase the dose frequency to 20 mg every

week.

Paediatric non-infectious uveitis

Age or body weight

How much and how often to take?

Notes

Age or body weight

How much and how often to take?

Notes

Children and

adolescents from

2 years of age

weighing 30 kg

or more

40 mg every other week

Your doctor may also prescribe a first dose of 80 mg which may be administered one week prior to the start of the usual dose of 40mg every other week. Hyrimoz is

recommended for the use in

combination with methotrexate.

Children and

adolescents from

2 years of age

weighing less

than 30 kg

20 mg every other week

Your doctor may also prescribe a first dose of 40 mg which may be administered one week prior to the start of the usual dose of 20 mg every other week. Hyrimoz is

recommended for the use in

combination with methotrexate.

Method and route of administration

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

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

If you use more Hyrimoz than you should

If you accidentally inject Hyrimoz more frequently than you should, call your doctor or pharmacist and explain that your child has received more medication than required. Always take the outer carton of medicine with you, even if it is empty.

If you forget to use Hyrimoz

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

If you stop using Hyrimoz

The decision to stop using Hyrimoz should be discussed with your child’s doctor. The symptoms may return upon stopping treatment.

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

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 up to 4 months or more after the last Hyrimoz injection.

Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:

• severe rash, hives;
• 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 and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
• symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
• signs of skin cancer such as a bump or open sore that doesn’t heal;
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.

The following side effects have been observed with adalimumab:

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

• injection site reactions (including pain, swelling, redness or itching);
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
• headache;
• abdominal (belly) pain;
• nausea and vomiting;
• rash;
• pain in the muscles.

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;
• mouth 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;
• symptoms of 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 room spinning);
• sensation of heart beating rapidly;

• high blood pressure;

  • flushing;
  • haematoma (a solid swelling with clotted blood);
  • 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 (a build-up of fluid in the body which causes the affected tissue to swell);
  • fever;
  • reduction in blood platelets which increases risk of bleeding or bruising;
  • impaired healing.

Uncommon (may affect up to 1 in 100 people)

• unusual 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, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
• immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor (shaking);
• neuropathy (nerve damage);
• 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);
• gallbladder inflammation, gallbladder stones;
• fatty liver (build-up of fat in liver cells);
• night sweats;
• scar;
• abnormal muscle breakdown;
• systemic lupus erythematosus (an immune disorder 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 inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition 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 wall of the gut);
  • hepatitis (liver inflammation);
  • reactivation of hepatitis B infection;
  • 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 (life-threatening reaction with flu-like symptoms and blistering rash);
  • facial oedema (swelling) associated with allergic reactions;
  • erythema multiforme (inflammatory skin rash);
  • lupus-like syndrome;
  • angioedema (localised swelling of the skin);
  • lichenoid skin reaction (itchy reddish-purple skin rash).

Not known (frequency cannot be estimated from available data)

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

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

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

• low blood measurements for white blood cells;
• low blood measurements for red blood cells;
• increased lipids in the blood;
• raised 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)

• raised 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 Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Hyrimoz

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

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

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

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

Alternative Storage:

When needed (for example when you are travelling), Hyrimoz may be stored at room temperature (up to 25°C) for a maximum period of 42 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, your pre-filled syringe must be used within 42 days or discarded, even if it is later returned to the refrigerator. You should record the date when your pre-filled syringe is first removed from the refrigerator, and the date after which it should be discarded.

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

Contents of the pack and other information

What Hyrimoz contains

• The active substance is adalimumab. Each pre-filled syringe contains 20 mg of adalimumab in 0.2 ml of solution.
• The other ingredients are adipic acid, mannitol (E 421), polysorbate 80 ( E 433), hydrochloric acid ( E 507), sodium hydroxide (E 524) and water for injections.

What Hyrimoz looks like and contents of the pack

Hyrimoz 20 mg solution for injection (injection) in pre-filled syringe for paediatric use is supplied as a 0.2 ml clear to slightly opalescent, colourless or slightly yellowish solution.

Hyrimoz is supplied in a single-use clear type I glass syringe with a stainless steel 29 gauge needle with finger flange, rubber needle cap (thermoplastic elastomer) and plastic plunger rod, containing 0.2 ml of solution.

Multipack carton contains 2 (2 packs of 1) pre-filled syringes of Hyrimoz.

Not all pack sizes may be marketed.

Hyrimoz is available as a pre-filled syringe and a pre-filled pen.

Marketing Authorisation Holder

Sandoz GmbH

Biochemiestr. 10

6250 Kundl

Austria

Manufacturer

Sandoz GmbH Schaftenau

Biochemiestr. 10

6336 Langkampfen

Austria

Or

Novartis Pharmaceutical Manufacturing GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

This leaflet was last revised in 04/2023 SZ23001LT01A Signature Panel:

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V027: Legal entity name change

30/04/2024

FuturaEF EL

990 x 690 mm