Mediclarum
Medicine guide

Hulio

·

  • Prescription status not stated
  • Cancer treatments and immune-system medicines
Active substance
Adalimumab
Made by
Biosimilar Collaborations Ireland Limited

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

Hulio is intended for the treatment of the following inflammatory diseases:

  • Hulio 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 uveitis The active substance in Hulio, 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 involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Hulio 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.
  • Hulio 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 Hulio to treat his/her polyarticular juvenile idiopathic arthritis.
  • Your doctor will decide if Hulio 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.
  • Hulio 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 Hulio to treat his/her 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.
  • Hulio is used to treat severe chronic 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.
  • Hulio 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 Hulio 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.
  • Hulio is used to treat children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Hulio works by reducing this inflammation.
  • Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Hulio to reduce the signs and symptoms of his/her disease.
  • Hulio is used to treat:
  • - children and adolescents aged 2 to 17 years with chronic non-infectious uveitis who have inflammation affecting the front of the eye.
  • 2. What you need to know before giving your child Hulio Do not give Hulio
  • - 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 (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 doctor or pharmacist before using Hulio.
  • Allergic reaction
  • • If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or a rash, do not inject more Hulio and contact your child’s 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 (e.g. leg ulcer), consult your child’s doctor before starting Hulio. If you are unsure, contact your child’s doctor.
  • • Your child might get infections more easily while he/she is receiving Hulio 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, or other unusual infectious organisms and sepsis (blood poisoning).
  • • In rare cases, these infections may be life-threatening. It is important to tell your child’s doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems. Your child’s doctor may recommend temporarily stopping Hulio.
  • • 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 Hulio. It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.
  • Tuberculosis (TB)
  • • As cases of tuberculosis have been reported in patients treated with adalimumab, your child’s doctor will check your child for signs and symptoms of tuberculosis before starting Hulio. 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 your child has been in close contact with someone who has had tuberculosis. If your child has active tuberculosis, do not use Hulio.
  • • 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 virus
  • • Tell your child’s 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 child’s doctor will 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 procedure
  • • If your child is about to have surgery or dental procedures, tell your child’s doctor that your child is taking Hulio. The doctor may recommend temporarily stopping Hulio.
  • 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 child’s doctor will decide if he/she should receive or continue to receive Hulio. Tell your child’s doctor immediately if your child gets symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.
  • Vaccination
  • • Certain vaccines contain living but weakened forms of bacteria or viruses that may cause infections and should not be given during treatment with Hulio.
  • • Check with your child’s doctor before he/she receives any vaccines.
  • • It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hulio.
  • • If your child received Hulio while she was pregnant, her baby may be at higher risk for getting such an infection for up to about five months after the last dose she received during her pregnancy. It is important that you tell the baby's doctors and other health care professionals about your child’s Hulio use during her pregnancy so they can decide when her baby should receive any vaccine.
  • Heart failure
  • • It is important to tell your child’s doctor if your child has had or has a serious heart condition. If your child has mild heart failure and is being treated with Hulio his/her heart failure status must be closely monitored by the doctor. If your child develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of the feet), you must contact your child’s doctor immediately.
  • Fever, bruising, bleeding or looking pale
  • • In some patients the body may fail to produce enough of the blood cells that fight infections or help your child to stop bleeding. If your child develops a fever that does not go away, or bruises or bleeds very easily or looks very pale, call your child’s doctor right away. Your child’s 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 (a cancer that affects the lymph system) and leukaemia (cancers that affect blood cells and bone marrow). If your child takes Hulio the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, a specific and severe type of lymphoma has been seen in some patients taking adalimumab. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your child’s doctor if your child is taking azathioprine or mercaptopurine with Hulio.
  • • 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 child’s doctor.
  • • There have been cases of cancers, other than lymphoma, reported 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 child’s doctor whether treatment with a TNFα blocker is appropriate for your child.
  • Autoimmune disease
  • • On rare occasions, treatment with adalimumab 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 Hulio Tell your child’s doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
  • Your child should not take Hulio with medicines containing the active substances anakinra or abatacept. The combination of Hulio 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 child’s doctor.
  • Hulio can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medicinal products including non-steroidal anti-inflammatory drugs (NSAIDs).
  • 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 her last Hulio injection.
  • • 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.
  • • Hulio 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.
  • • Hulio can be used during breast-feeding.
  • • If your child receives Hulio during her pregnancy, her 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 Hulio use during her pregnancy before the baby receives any vaccine. For more information on vaccines, see “Warnings and precautions”.
  • Driving and using machines Hulio may have a minor influence on your child’s ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking Hulio.
  • Hulio contains sodium,sorbitol and polysorbate 80 Each Hulio pre-filled syringe contains 19.1 mg of sorbitol. Sorbitol is a source of fructose. If your child’s doctor has told you that your child has an intolerance to some sugars or if your child has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your child’s doctor before you give your child this medicine.
  • This medicine contains less than 1 mmol of sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free’.
  • This medicinal product contains 0.4 mg of polysorbate 80 in each 20 mg pre-filled syringe which is equivalent to 1.0 mg/mL. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

From the package leaflet in EMA’s product information, p. 165–170 · 2026-08-27

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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 Hulio if your child needs a different dose.
  • Children with juvenile idiopathic arthritis Children and adolescents from 2 to 17 years of age weighing 10 kg to less than 30 kg:
  • The recommended dose of Hulio is 20 mg every other week.
  • Children and adolescents from 2 to 17 years of age weighing 30 kg or more:
  • The recommended dose of Hulio is 40 mg every other week.
  • Children and adolescents with enthesitis-related arthritis Children and adolescents from 6 to 17 years of age weighing 15 kg to less than 30 kg:
  • The recommended dose of Hulio is 20 mg every other week.
  • Children and adolescents from 6 to 17 years of age weighing 30 kg or more:
  • The recommended dose of Hulio is 40 mg every other week.
  • Children or adolescents with paediatric plaque psoriasis Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg:
  • The recommended dose of Hulio 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 Hulio is an initial dose of 40 mg, followed by 40 mg one week later, Thereafter the usual dose is 40 mg every other week.
  • Children and adolescents with paediatric 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 (as two 20 mg injections in one day), 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 four 20 mg injections in one day) 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.
  • Children and adolescents from 6 to 17 years of age weighing 40 kg or more:
  • The usual dose regimen is 80 mg initially (as four 20 mg injections in one day), 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 (as eight 20 mg injections in one day or four 20 mg injections per day for two consecutive days) followed by 80 mg (as four 20 mg injections in one day) 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 dose to 40 mg every week or 80 mg every other week.
  • Children and adolescents with paediatric uveitis Children and adolescents from 2 to 17 years of age weighing less than 30 kg:
  • The usual dose of Hulio is 20 mg every other week with methotrexate.
  • Your child’s doctor may also prescribe an initial dose of 40 mg (as two 20 mg injections in one day)
  • which may be administered one week prior to the start of the usual recommended dose. Hulio is recommended for use in combination with methotrexate.
  • Children and adolescents from 2 to 17 years of age weighing 30 kg or more:
  • The usual dose of Hulio 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 of 40 mg every other week. Hulio is recommended for use in combination with methotrexate.
  • Method and route of administration Hulio is administered by injection under the skin (subcutaneous use).
  • Detailed instructions on how to inject Hulio are provided in Instructions for use.
  • If you use more Hulio than you should If you accidentally inject your child with Hulio more frequently than you should, call your child’s doctor or pharmacist and explain that your child has been given more than required. Always take the outer carton or the medicine with you, even if it is empty.
  • If you forget to use Hulio If you forget to give your child an injection, you should inject the next dose of Hulio 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 your child stops using Hulio The decision to stop using Hulio should be discussed with your child’s doctor. Your child’s symptoms may return upon stopping treatment.
  • If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 170–171.

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 urgent medical treatment.
  • Side effects may occur up to 4 months or more after the last Hulio injection.
  • Seek medical attention urgently if your child develops any of the following signs of allergic reaction or heart failure:
  • severe rash, hives;
  • swollen face, hands or feet;
  • trouble breathing or 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 signs and symptoms described above can represent the side effects listed below, which have been observed with adalimumab.
  • Very common (may affect more than 1 in 10 people):
  • injection site reactions (including pain, swelling, redness or itching);
  • respiratory tract infections (including cold, runny nose, sinus infection, throat infection, pneumonia);
  • headache;
  • abdominal (belly) pain;
  • nausea and vomiting;
  • rash;
  • pain in bone and 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;
  • oral infections (including tooth infections and cold sores);
  • reproductive tract infections;
  • urinary tract infection;
  • fungal infections;
  • joint infections;
  • benign tumours;
  • skin cancer;
  • mild 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/eyelid inflammation or swelling;
  • vertigo (sensation of the room spinning);
  • sensation of heart beating rapidly;
  • high blood pressure;
  • skin flushing;
  • haematoma (collection of blood outside of blood vessels);
  • cough;
  • asthma;
  • shortness of breath;
  • gastrointestinal bleeding;
  • indigestion, bloating, heart burn;
  • acidity/acid reflux;
  • sicca syndrome (including dry eyes and dry mouth);
  • bruising;
  • itchy rash;
  • itching, inflammation of the skin (including eczema);
  • breaking of finger nails and toe nails;
  • increased sweating;
  • hair loss;
  • new or worsening psoriasis (red, flaky skin);
  • muscle spasms;
  • blood in urine;
  • kidney problems;
  • chest pain;
  • oedema (swelling);
  • fever;
  • reduction in blood platelets which increases risk of bleeding or bruising;
  • slow healing of wounds.
  • 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;
  • lymphoma (cancer of the lymph system );
  • melanoma;
  • 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;
  • irregular heart beat;
  • 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);
  • excessive fluid around the lung;
  • inflammation of the pancreas;
  • difficulty in swallowing;
  • swelling of the face (facial oedema );
  • gallbladder inflammation, gallbladder stones;
  • fatty liver (build up of fat in liver cells);
  • night sweats;
  • scarring;
  • 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 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/tear in the intestine);
  • hepatitis (inflammation of the liver;
  • reactivation of hepatitis B;
  • autoimmune hepatitis (inflammation of the liver caused by the body’s own immune disease);
  • 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;
  • 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);
  • 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 skin rash with muscle weakness;
  • Weight gain (for most patients, the weight gain was small).
  • 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 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. 172–174.

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/ carton after EXP. The expiry date refers to the last day of that month.
  • Store in a refrigerator (2°C – 8°C). Do not freeze.
  • Keep the pre-filled syringe in the outer carton in order to protect from light.
  • Alternative storage:
  • When needed (for example, when you are travelling), a single Hulio pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 8 weeks – be sure to protect it from light.
  • Once removed from the refrigerator for room temperature storage, the syringe must be used within 8 weeks 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 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. 175.

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.

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United StatesNo exact match for this strength and form

Every strength and form (4)

SpainNo exact match for this strength and form

Every strength and form (41)

FranceNo exact match for this strength and form

Every strength and form (46)

CanadaNo exact match for this strength and form

Every strength and form (45)

NetherlandsNo exact match for this strength and form

Every strength and form (51)

SwitzerlandNo exact match for this strength and form

Every strength and form (44)

Details

Made byBiosimilar Collaborations Ireland Limited
Active substanceAdalimumab
Used inCancer treatments and immune-system medicines
ClassificationL04AB04 · Cancer treatments and immune-system medicines
BiosimilarYes — a biosimilar medicine, according to the register
Authorised on2018-09-17
Last updated by the regulator2026-08-27
EMA product numberEMEA/H/C/004429

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).

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