Medicine guide
Hefiya
·
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Adalimumab
- Made by
- Sandoz GmbH
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Hefiya is intended for the treatment of the following inflammatory diseases:
- Hefiya contains the active substance adalimumab, a medicine that acts on your body’s immune (defence) system.
- • polyarticular juvenile idiopathic arthritis,
- • enthesitis-related arthritis
- • paediatric plaque psoriasis,
- • paediatric Crohn’s disease,
- • paediatric non-infectious uveitis.
- The active substance in Hefiya, 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, Hefiya blocks its action and reduces the inflammation in these diseases.
- Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
- Hefiya 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. Patients may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, patients will be given Hefiya to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
- Paediatric plaque psoriasis 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.
- Hefiya 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.
- Hefiya 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 Hefiya 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). Hefiya works by reducing this inflammation.
- Hefiya 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 Hefiya to reduce the signs and symptoms of his/her disease.
- 2. What you need to know before your child uses Hefiya Do not use Hefiya
- • 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 Hefiya.
- Allergic reaction
- • If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Hefiya and contact your doctor immediately, since in rare cases, these reactions can be life-threatening.
- Infection
- • If your child has an infection, including long-term or localised infection (for example leg ulcer), consult your doctor before starting Hefiya. If you are unsure, contact your doctor.
- • Your child might get infections more easily while he/she is receiving Hefiya 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 Hefiya.
- 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 Hefiya. 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, listlessness, 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 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 contracting 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 Hefiya. Your doctor may recommend temporarily stopping Hefiya.
- 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 Hefiya. 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 Hefiya 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 Hefiya.
- If your child receives Hefiya 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 Hefiya use during herpregnancy 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 Hefiya, 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 Hefiya, 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 Hefiya.
- • 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 Hefiya 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 Hefiya Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
- Hefiya 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 Hefiya 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 Hefiya 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.
- • Hefiya 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.
- • Hefiya can be used during breast-feeding.
- • If your child receives Hefiya 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 Hefiya 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 Hefiya 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 Hefiya.
- Hefiya contains sodium This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 ml dose, that is to say essentially ‘sodium-free’.
From the package leaflet in EMA’s product information, p. 172–176 · 2026-02-16
How to take it
These directions are for this exact strength and form. Another one is different.
- Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- Hefiya is available as a 40 mg pen as well as 20 mg and 40 mg pre-filled syringes for patients to administer a full 20 mg or 40 mg dose.
- Polyarticular juvenile idiopathic arthritis Age and body weight How much and how often Notes to take?
- Children, adolescents and 40 mg every other week Not applicable adults from 2 years of age weighing 30 kg or more Children, adolescents from 2 20 mg every other week Not applicable years of age weighing 10 kg to less than 30 kg Enthesitis-related arthritis Age and body weight How much and how often Notes to take?
- Children, adolescents and 40 mg every other week Not applicable adults from 6 years of age weighing 30 kg or more Children, adolescents from 20 mg every other week Not applicable 6 years of age weighing 15 kg to less than 30 kg Paediatric plaque psoriasis Age and body weight How much and how often Notes to take?
- Children and adolescents from First dose of 40 mg, Not applicable 4 to 17 years of age weighing followed by 40 mg one 30 kg or more week later.
- Thereafter, the usual dose is 40 mg every other week.
- Children and adolescents from First dose of 20 mg, followed Not applicable 4 to 17 years of age weighing by 20 mg one week later.
- 15 kg to less than 30 kg Thereafter, the usual dose is 20 mg every other week.
- Paediatric Crohn’s disease Age and body weight How much and how often Notes to take?
- Children and adolescent from 6 First dose of 80 mg (as two If this dose does not work to 17 years of age weighing 40 mg injections in one day), well enough, your child’s 40 kg or more followed by 40 mg every other doctor may increase the dose week starting two weeks later. to 40 mg every week or 80 mg every other week.
- If a faster response is required your doctor may prescribe a first 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.
- Thereafter the usual dose is 40 mg every other week.
- Children and adolescents from First dose of 40 mg, followed If this dose does not work well 6 to 17 years of age weighing by 20 mg every other week enough, your child’s doctor less than 40 kg starting two weeks later. may increase the dose frequency to 20 mg every week.
- If a faster response is required, your doctor may prescribe a first 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.
- Paediatric non-infectious uveitis Age and body weight How much and how often Notes to take?
- Children and adolescents from 40 mg every other week with Your doctor may also 2 years of age weighing 30 kg methotrexate prescribe a first dose of 80 mg or more which may be administered one week prior to the start of the usual dose.
- Children and adolescents from 20 mg every other week with Your doctor may also 2 years of age weighing less methotrexate prescribe a first dose of 40 mg than 30 kg which may be administered one week prior to the start of the usual dose.
- Method and route of administration Hefiya is administered by injection under the skin (by subcutaneous injection).
- Detailed instructions on how to inject Hefiya are provided in section 7, “Instructions for use”.
- If you use more Hefiya than you should If you accidentally inject Hefiya 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 Hefiya If you forget to give your child an injection, you should inject the next dose of Hefiya 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 Hefiya The decision to stop using Hefiya 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.
From the package leaflet in EMA’s product information, p. 176–178.
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 Hefiya 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 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 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;
- neuropathy (nerve damage);
- stroke;
- double vision;
- 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
From the package leaflet in EMA’s product information, p. 179–182.
How to store it
- 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), Hefiya may be stored at room temperature (up to 25°C) for a maximum period of 21 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 21 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.
From the package leaflet in EMA’s product information, p. 182.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Sandoz GmbH |
|---|---|
| Active substance | Adalimumab |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L04AB04 · Cancer treatments and immune-system medicines |
| Biosimilar | Yes — a biosimilar medicine, according to the register |
| Authorised on | 2018-07-26 |
| Last updated by the regulator | 2026-02-16 |
| EMA product number | EMEA/H/C/004865 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.
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