HYRIMOZ 20 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the Patient

Hyrimoz 20 mg solution for injection in pre-filled syringe

adalimumab

20 mg/0.2 ml

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 give you a patient information card, which contains important safety information that you need to know before your child starts using Hyrimoz and during treatment with Hyrimoz. Keep this patient information cardwith you or with your child during treatment and for the 4 months following the last injection of Hyrimoz.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Hyrimoz and what is it used for
2. What you need to know before your child starts using Hyrimoz
3. How to use Hyrimoz
4. Possible side effects
5. Storing Hyrimoz
6. Package contents and further information
7. Instructions for use

1. What is Hyrimoz and what is it used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on the immune system (defence system) of the body.

Hyrimoz is indicated for the treatment of inflammatory diseases described below:

• juvenile idiopathic polyarticular arthritis,
• enthesitis-related arthritis,
• paediatric plaque psoriasis,
• paediatric Crohn's disease,
• paediatric non-infectious uveitis.

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

The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is found in high concentrations in the inflammatory diseases described above. By binding to TNFα, Hyrimoz blocks its action and reduces inflammation in these diseases.

Juvenile idiopathic polyarticular arthritis

Juvenile idiopathic polyarticular arthritis is an inflammatory disease of the joints.

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

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease of the joints and areas where tendons attach to bones.

Hyrimoz is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years. Patients may have first received other disease-modifying drugs, such as methotrexate. If these drugs do not work well enough, patients will receive Hyrimoz to treat their enthesitis-related arthritis.

Paediatric plaque psoriasis

Psoriasis is an inflammatory disease of the skin that causes red, scaly, crusty, and silvery-scaled patches. Psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift off the nail bed, which can be painful. It is believed that psoriasis is caused by a defect in the body's immune system that leads to an increase in skin cell production.

Hyrimoz is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years who have not responded or are not suitable for topical treatments or ultraviolet (UV) light therapy.

Paediatric Crohn's disease

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

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

Your child may be treated first with other medications. If these medications do not work well enough, your child will receive Hyrimoz to reduce the signs and symptoms of their disease.

Paediatric non-infectious uveitis

Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye. The inflammation causes a decrease in vision and/or the presence of floaters in the eye (black dots or thin 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 that affects the front part of the eye.

Your child may be treated first with other medications. If these medications do not work well enough, your child will receive Hyrimoz to reduce the signs and symptoms of their disease.

2. What you need to know before your child starts using 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 (uncommon infections associated with a weakened immune system). If your child shows symptoms of any infection, such as fever, wounds, fatigue, dental problems, it is essential that you inform your doctor (see "Warnings and precautions").

• If your child has moderate or severe heart failure. It is essential that you tell your doctor if your child has had or has any serious heart problems (see "Warnings and precautions").

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Hyrimoz.

Allergic reaction

• If your child has an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or rash, stop administering Hyrimoz and contact your doctor immediately, as these reactions can be life-threatening.

Infections

• If your child has any infection, including chronic or localized infections (e.g., a leg ulcer), consult your doctor before starting treatment with Hyrimoz. If you are unsure, contact your doctor.

• With Hyrimoz treatment, your child may be more likely to get infections. This risk may be higher if your child's lung function is reduced. These infections can be serious and include tuberculosis, viral, fungal, parasitic, or bacterial infections, or other uncommon infectious organisms, and sepsis (blood poisoning).

• In rare cases, these infections can be life-threatening. It is essential that if your child shows symptoms such as fever, wounds, fatigue, or dental problems, you inform your doctor. Your doctor may recommend temporarily stopping treatment with Hyrimoz.

Tuberculosis (TB)

• Since cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will examine your child for signs or symptoms of tuberculosis before starting treatment with Hyrimoz. This includes a thorough medical evaluation, including medical history and diagnostic tests (e.g., chest X-ray and tuberculin test) of your child. The performance and results of these tests should be recorded on your child's patient information card. It is crucial that you inform your doctor if your child has had tuberculosis or has been in contact with a patient with tuberculosis. Tuberculosis can develop during treatment, even if your child has received preventive treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or any other infection appear during or after treatment, contact your doctor immediately.

Travel/infection recurrence

• Inform your doctor if your child has lived or traveled in areas where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.

• Inform your doctor if your child has a history of recurrent infections or other conditions or factors that increase the risk of infections.

Hepatitis B virus

• Inform your doctor if your child is a carrier of the hepatitis B virus (HBV), has an active HBV infection, or if you think they may be at risk of getting HBV. Your doctor should perform an HBV test on your child. Adalimumab may reactivate HBV in people who carry this virus. In rare cases, especially if your child is taking other medications that suppress the immune system, reactivation of HBV infection can be life-threatening.

Dental procedures or surgery

• If your child is to undergo surgery or dental procedures, inform your doctor that they are taking Hyrimoz. Your doctor may recommend temporarily stopping treatment with Hyrimoz.

Demyelinating disease

• If your child has or develops a demyelinating disease (a disease that affects the protective covering of nerves, such as multiple sclerosis), your doctor will decide whether they should be treated or continue treatment with Hyrimoz. Inform your doctor immediately if they have symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccines

• Certain vaccines contain live, attenuated forms of bacteria or viruses, which can cause disease and should not be administered during treatment with Hyrimoz, as they may cause infections. Consult your doctor before administering any vaccine to your child. It is recommended, if possible, that children receive all scheduled vaccinations for their age before starting treatment with Hyrimoz.

If your daughter uses Hyrimoz while pregnant, the baby may have a higher risk of getting infections for about 5 months after the last dose of Hyrimoz she received during pregnancy. It is essential that you inform the baby's doctor and other healthcare professionals that your daughter used Hyrimoz during pregnancy, so they can decide whether the baby should receive any vaccine (for more information on vaccines, see the "Warnings and precautions" section).

Heart failure

• It is essential that you inform your doctor if your child has had or has any serious heart problems. If your child has mild heart failure and is being treated with Hyrimoz, your doctor should closely monitor their heart failure. If your child develops new symptoms of heart failure or their current symptoms worsen (e.g., difficulty breathing, swelling of the feet), they should contact their doctor immediately.

Fever, bruising, bleeding, or pale appearance

• In some patients, the body may be unable to produce enough of the type of blood cells that fight infections (white blood cells) or those that help stop bleeding (platelets). If your child has persistent fever, bruising, or bleeding easily, or is very pale, consult your doctor immediately. Your doctor may decide to interrupt treatment.

Cancer

• In very rare cases, certain types of cancer have been reported in children and adults treated with adalimumab or other TNFα blockers. People with rheumatoid arthritis, especially those with severe and long-standing disease, may have a higher-than-average risk of developing lymphoma and leukaemia (cancer that affects blood cells and bone marrow). If your child is being treated with Hyrimoz, the risk of developing lymphoma, leukaemia, and other types of cancer may increase. A specific and severe type of lymphoma has been observed in rare cases in patients treated with adalimumab. Some of these patients were also receiving treatment with azathioprine or mercaptopurine. Inform your doctor if your child is taking azathioprine or mercaptopurine with Hyrimoz.

• Cases of non-melanoma skin cancer have been observed in patients using adalimumab. Inform your doctor if new areas of damaged skin appear or if existing damaged areas change in appearance during or after treatment.

• Cases of cancer, other than lymphoma, have been reported in patients with a certain lung disease, chronic obstructive pulmonary disease (COPD), treated with another TNFα blocker. If your child has COPD or is a heavy smoker, they should consult their doctor to determine whether treatment with a TNFα blocker is suitable for them.

Autoimmune diseases

• In rare cases, treatment with Hyrimoz may lead to a lupus-like syndrome. Contact your doctor if you have symptoms such as unexplained persistent rash, fever, joint pain, or fatigue.

Other medicines and Hyrimoz

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

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

Your child must not use Hyrimoz with medicines whose active substances are anakinra or abatacept due to an increased risk of serious infections. It is not recommended to combine adalimumab and other TNFα blockers with anakinra or abatacept, due to the possible increased risk of infections, including serious infections, and other potential drug interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• Your daughter should consider using adequate contraceptive methods to avoid becoming pregnant and continue using them for at least 5 months after the last treatment with Hyrimoz.

• If your daughter is pregnant, thinks she may be pregnant, or plans to have a baby, she should ask her doctor for advice before using this medicine.
• Hyrimoz should be used during pregnancy only if necessary.
• According to a pregnancy study, there was no increased risk of congenital malformations when the mother had received adalimumab treatment during pregnancy compared to mothers with the same disease who did not receive adalimumab treatment.
• Hyrimoz can be used during breastfeeding.
• If your daughter uses Hyrimoz while pregnant, the baby may have a higher risk of getting infections.
• It is essential that you inform the baby's doctor and other healthcare professionals that your daughter used Hyrimoz during pregnancy, so they can decide whether the baby should receive any vaccine (for more information on vaccines, see the "Warnings and precautions" section).

Driving and using machines

Hyrimoz has a minor influence on the ability to drive, ride a bicycle, or use machines. Dizziness and vision disturbances may occur after using Hyrimoz.

Hyrimoz contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 0.2 ml dose; this is essentially "sodium-free".

3. How to use Hyrimoz

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor again.

The recommended doses of Hyrimoz for each of the approved uses are shown in the following table. Your doctor may prescribe a different dose of Hyrimoz if your child needs a different dose.

Form and route of administration

Hyrimoz is injected under the skin (subcutaneously).

Detailed instructions on how to inject Hyrimoz are found 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 necessary. Always carry the medication box 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, give your child the next dose as usual, as if you had not forgotten a dose.

If you interrupt treatment with Hyrimoz

The decision to stop using Hyrimoz should be discussed with your child's doctor. Symptoms may return after stopping treatment.

If you have any other questions about the use of this medication, 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 can be serious and require treatment. Side effects may appear up to 4 months or more after the last injection of Hyrimoz.

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

• severe rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, swallowing;
• difficulty breathing when exercising or when lying down or swelling of the feet.

Contact your doctor as soon as possibleif you notice any of the following effects:

• signs and symptoms of infection such as fever, nausea, wounds, dental problems, burning sensation when urinating, feeling of weakness, fatigue, or cough;
• symptoms of nervous system problems, such as tingling, numbness, double vision, weakness in arms or legs;
• signs of skin cancer, such as a lump or an open sore that does not heal;
• signs and symptoms of blood disorders such as persistent fever, bruising, bleeding, and paleness.

The following side effects have been observed with adalimumab:

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

• reactions at the injection site (including pain, swelling, redness, or itching);
• lower respiratory tract infections (including colds, runny nose, sinusitis, pneumonia);
• headache;
• abdominal pain (stomach);
• nausea and vomiting;
• rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• serious infections (including blood poisoning and flu);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes);
• ear infection;
• mouth infections (including dental infection and cold sore);
• infections of the reproductive system;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• difficulty sleeping;
• sensory disturbances such as tingling, itching, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• vertigo (feeling of spinning);
• feeling of rapid heartbeat;
• high blood pressure;
• flushing;
• bruises (solid swelling with clotted blood);
• cough;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• indigestion (indigestion, bloating, and heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and mouth);
• itching;
• itchy rash;
• bruises;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• new onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body that can cause swelling of the affected tissue);
• fever;
• decrease in platelet count in blood, which increases the risk of bleeding or bruising;
• wound healing problems.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections that occur when disease resistance decreases);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• cancer, including lymphoma (a type of cancer that affects the lymphatic system) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin, and lymph nodes (the most common presentation is in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremors (feeling shaky);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat like skips;
• heart problems that can cause difficulty breathing or swelling of the ankles;
• heart attack;
• aneurysm (balloon in the wall of a major artery), inflammation, and clotting in a vein, blockage of a blood vessel;
• pulmonary diseases that can cause difficulty breathing (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal fluid accumulation in the pleural space);
• pancreatitis (inflammation of the pancreas that causes severe abdominal and back pain);
• difficulty swallowing;
• facial edema (swelling);
• gallbladder inflammation; gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scars;
• abnormal muscle crisis;
• systemic lupus erythematosus (an immune system disorder that includes inflammation of the skin, heart, lungs, joints, and other organs);
• sleep disturbances;
• impotence;
• inflammations.

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

• leukemia (cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• nervous system disorders (such as optic neuritis and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring in the lungs);
• intestinal perforation (hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B virus 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 (a potentially life-threatening disease with flu-like symptoms and blistering rash);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory rash on the skin);
• lupus-like syndrome;
• angioedema (localized skin swelling);
• lichenoid reaction on the skin (purplish-red rash with itching).

Frequency not known(cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare and often fatal blood cancer);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually occurs more frequently as purple-colored skin lesions;
• liver failure;
• worsening of a disease called dermatomyositis (seen as a skin rash accompanied by muscle weakness);
• weight gain (for most patients, weight gain was reduced).

Some side effects observed in clinical studies with adalimumab do not have symptoms and can only be identified through a blood test. These include:

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

• low white blood cell count;
• low red blood cell count;
• increased lipids in blood;
• high liver enzymes.

Common(may affect up to 1 in 10 people)

• high white blood cell count;
• low platelet count;
• increased uric acid in blood;
• abnormal sodium levels in blood;
• low calcium levels in blood;
• low phosphate levels in blood;
• high blood sugar;
• high lactate dehydrogenase levels in blood;
• presence of autoantibodies in blood;
• low potassium levels in blood.

Uncommon(may affect up to 1 in 100 people)

• high bilirubin levels (liver function blood test).

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

• low counts in blood for white blood cells, red blood cells, and platelets.

Reporting of side effects

If your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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/box after “EXP”. The expiry date is the last day of the month indicated.

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

Store the pre-filled syringe in the outer packaging to protect it from light.

Alternative storage:

When necessary (e.g., when traveling), you can store Hyrimoz at room temperature (up to 25°C) for a maximum period of 42 days (make sure to protect it from light). Once the pre-filled syringe is removed from the refrigerator to store it at room temperature, it must be used within the next 42 days or discarded, even if it is later returned to the refrigerator. You must note the date when you removed the pre-filled syringe from the refrigerator and the date after which it must be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Hyrimoz

• The active substance is adalimumab. Each pre-filled syringe contains 20 mg of adalimumab in 0.2 ml of solution.

• The other components are: adipic acid manitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524), and water for injectable preparations (see section 2 "Hyrimoz contains sodium").

Appearance of the Product and Container Contents

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

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

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

Only certain pack sizes may be marketed.

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

Marketing Authorization Holder

Sandoz GmbH

Biochemiestr. 10

6250 Kundl

Austria

Manufacturer

Sandoz GmbH Schaftenau

Biochemiestr. 10

6336 Langkampfen

Austria

Novartis Pharmaceutical Manufacturing GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

You can request more information about this medicinal product from the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu.

1. Instructions for Use

To help avoid possible infections and ensure correct use of the medicinal product, it is important that you follow these instructions.

Make sure you read, understand, and follow these instructions for use before injecting Hyrimoz. Your healthcare professional should have taught you how to prepare and inject Hyrimoz with the pre-filled syringe correctly before you use it for the first time. If you have any questions, consult your healthcare professional.

Your Hyrimoz Single-Use Pre-filled Syringe

Figure A:Hyrimoz pre-filled syringe

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