Medicine guide

Hukyndra

Prescription status not stated
Cancer treatments and immune-system medicines

Active substance: Adalimumab
Used in: Cancer treatments and immune-system medicines
Made by: Stada Arzneimittel AG
Source: Official label

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

What it is for

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

Hukyndra contains the active substance adalimumab.
• Polyarticular juvenile idiopathic arthritis
• Enthesitis-related arthritis
• Paediatric plaque psoriasis
• Paediatric Crohn’s disease
• Paediatric uveitis The active ingredient in Hukyndra, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (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, Hukyndra 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.
Hukyndra 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 Hukyndra to treat his/her polyarticular juvenile idiopathic arthritis.
Your doctor will decide if Hukyndra 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.
Hukyndra 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 Hukyndra to treat his/her enthesitis-related arthritis.
Paediatric plaque psoriasis Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful. Psoriasis is believed to be caused by a problem with the body’s immune system that leads to an increased production of skin cells.
Hukyndra is used to treat severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Paediatric Crohn’s disease Crohn’s disease is an inflammatory disease of the digestive tract.
Hukyndra 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 Hukyndra 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.
Hukyndra 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). Hukyndra 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 Hukyndra to reduce the signs and symptoms of his/her disease.
2. What you need to know before your child uses Hukyndra Do not use Hukyndra
• If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
• If your child has active tuberculosis or other severe infections (see “Warnings and precautions”). It is important that you tell your doctor if your child has symptoms of infections, for example, fever, wounds, feeling tired, dental problems.
• If your child has moderate or severe heart failure. It is important to tell your doctor if your child has had or has a serious heart condition (see “Warnings and precautions”).
Warnings and precautions Talk to your doctor or pharmacist before using Hukyndra.
Allergic reactions
• If your child gets allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Hukyndra and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Infections
• If your child has an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doctor before starting Hukyndra. If you are unsure, contact your doctor.
• Your child might get infections more easily while he/she is receiving Hukyndra treatment. This risk may increase if your child has problems with his/her lungs. These infections may be serious and include:
o tuberculosis o infections caused by viruses, fungi, parasites or bacteria o severe infection in the blood (sepsis)
In rare cases, these infections can be life-threatening. It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may tell you to stop using Hukyndra for some time.
• Tell your doctor if your child lives or travels in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
• Tell your doctor if your child has had infections which keep coming back or other conditions that increase the risk of infections.
• Your child and his/her doctor should pay special attention to signs of infection while your child is being treated with Hukyndra. It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Tuberculosis
• As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check your child for signs and symptoms of tuberculosis before starting Hukyndra. This will include a thorough medical evaluation including your child’s medical history and appropriate screening tests (for example, chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your child’s Patient Reminder Card.
o 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 Hukyndra.
o Tuberculosis can develop during therapy even if your child has received treatment for the prevention of tuberculosis.
o If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Hepatitis B
• Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV or if you think he/she might be at risk of getting HBV.
o Your doctor should test your child for HBV. In people who carry HBV, adalimumab can cause the virus to become active again.
o In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
Surgery or dental procedure
• If your child is about to have surgery or dental procedures, please inform your doctor that your child is taking Hukyndra. Your doctor may recommend temporary discontinuation of Hukyndra.
Demyelinating disease
• If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Hukyndra. Tell your doctor immediately if your child experiences symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.
Vaccinations
• Certain vaccines may cause infections and should not be given while receiving Hukyndra.
o Check with your doctor before your child receives any vaccines.
o It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Hukyndra.
o If your child received Hukyndra while she was pregnant, her baby may be at higher risk for getting such an infection for up to approximately five months after the last Hukyndra dose she received during pregnancy. It is important that you tell her baby's doctors and other health care professionals about your child’s Hukyndra use during her pregnancy so they can decide when her baby should receive any vaccine.
Heart failure
• If your child has mild heart failure and is being treated with Hukyndra, his/her heart failure status must be closely monitored by your doctor. It is important to tell your doctor if your child has had or has a serious heart condition. If he/she develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. Your doctor will decide if your child should receive Hukyndra.
Fever, bruising, bleeding or looking pale
• In some patients the body may fail to produce enough of the blood cells that fight off infections or help your child to stop bleeding. Your doctor may decide to stop treatment. If your child develops a fever that does not go away, develops light bruises or bleeds very easily or looks very pale, call your doctor right away.
Cancer
• There have been very rare cases of certain kinds of cancer in children and adult patients taking adalimumab or other TNF blockers.
o People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
o If your child takes Hukyndra the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma, has been seen in patients taking adalimumab. Some of those patients were also treated with azathioprine or 6- mercaptopurine.
o Tell your doctor if your child is taking azathioprine or 6-mercaptopurine with Hukyndra.
o Cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
o If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
• There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker. If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for your child.
Autoimmune disease
• On rare occasions, treatment with Hukyndra 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 Hukyndra Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Your child should not take Hukyndra with medicines containing the following active substances due to increased risk of serious infection:
• anakinra
• abatacept.
Hukyndra can be taken together with:
• methotrexate
• certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations)
• steroids or pain medicines including non-steroidal anti-inflammatory drugs (NSAIDs).
If you have questions, please ask your doctor.
Pregnancy and breast-feeding
• Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hukyndra treatment.
• If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.
• Hukyndra 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.
• Hukyndra can be used during breast-feeding.
• If your child received Hukyndra during her pregnancy, her baby may have a higher risk for getting an infection.
• It is important that you tell her baby’s doctor and other health care professionals about her Hukyndra 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 Hukyndra may have a small effect on your child’s ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Hukyndra.
Hukyndra contains sodium and polysorbate 80 This medicine contains less than 1 mmol sodium (23 mg) per 0.2 ml, that is to say essentially ‘sodium- free’.
This medicine contains 1 mg of polysorbate 80 in each ml. Polysorbates may cause allergic reactions.
Tell your doctor if your child has any known allergies.

From the package leaflet in EMA’s product information, p. 163–168 · 2026-07-17

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.
The recommended doses for Hukyndra in each of the approved uses are shown in the following table.
Your doctor may prescribe another strength of Hukyndra if your child needs a different dose.
Polyarticular juvenile idiopathic arthritis Age or body weight How much and how often to take? Notes Children, adolescents 40 mg every other week Not applicable and adults from 2 years of age weighing 30 kg or more Children and 20 mg every other week Not applicable adolescents from 2 years of age weighing 10 kg to less than 30 kg Enthesitis-related arthritis Age or body weight How much and how often to take? Notes Children, adolescents 40 mg every other week Not applicable and adults from 6 years of age weighing 30 kg or more Children and 20 mg every other week Not applicable adolescents from 6 years of age weighing 15 kg to less than 30 kg Paediatric plaque psoriasis Age or body weight How much and how often to take? Notes Children and First dose of 40 mg, followed by 40 mg Not applicable adolescents from 4 to one week later.
17 years of age weighing 30 kg or Thereafter, the usual dose is 40 mg more every other week.
Children and First dose of 20 mg, followed by 20 mg Not applicable adolescents from 4 to one week later.
17 years of age weighing 15 kg to Thereafter, the usual dose is 20 mg less than 30 kg every other week.
Paediatric Crohn’s disease Age or body weight How much and how often to take? Notes Children and First dose of 80 mg, followed by 40 mg Your child’s doctor may adolescents from 6 to two weeks later. increase the dosage to 40 mg 17 years of age every week or 80 mg every other weighing 40 kg or If a faster response is required, your week.
more child’s doctor may prescribe a first dose of 160 mg, followed by 80 mg two weeks later.
Thereafter, the usual dose is 40 mg every other week.
Children and First dose of 40 mg, followed by 20 mg Your child’s doctor may adolescents from 6 two weeks later. increase the dose frequency to to 17 years of age 20 mg every week.
weighing less than If a faster response is required, the 40 kg 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.
Paediatric uveitis Age or body weight How much and how often to take? Notes Children and 20 mg every other week Your doctor may prescribe an adolescents from initial dose of 40 mg to be 2 years of age administered one week prior to weighing less than the start of the usual dose of 30 kg 20 mg every other week.
Hukyndra is recommended for use in combination with methotrexate.
Children and 40 mg every other week Your doctor may prescribe an adolescents from initial dose of 80 mg to be 2 years of age administered one week prior to weighing 30 kg or the start of the usual dose of more 40 mg every other week.
Hukyndra is recommended for use in combination with methotrexate.
Method and route of administration Hukyndra is administered by injection under the skin (by subcutaneous injection).
Detailed instructions on how to inject Hukyndra are provided in section 7 ‘Instructions for use’.
If you use more Hukyndra than you should If you accidentally inject Hukyndra more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that your child has taken more. Always take the outer carton of the medicine with you, even if it is empty.
If you forget to use Hukyndra If you forget to give your child an injection, you should inject the next dose of Hukyndra as soon as you remember. Then give your child’s next dose as you would have on the originally scheduled day, had you not forgotten a dose.
If you stop using Hukyndra The decision to stop using Hukyndra should be discussed with your doctor. Your child’s symptoms may return if you stop using Hukyndra.
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. 168–170.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Hukyndra injection.
Tell your doctor immediately if you notice any of the following
severe rash, hives or other signs of allergic reaction
swollen face, hands, feet
trouble breathing, swallowing
shortness of breath with physical activity or upon lying down or swelling of the feet Tell your doctor as soon as possible if you notice any of the following
signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
feeling weak or tired
coughing
tingling
numbness
double vision
arm or leg weakness
a bump or open sore that doesn't heal
signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness The symptoms described above can be signs of the below listed side effects, which have been observed with 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 pain
nausea and vomiting
rash
musculoskeletal pain Common (may affect up to 1 in 10 people)
serious infections (including blood poisoning and influenza)
intestinal infections (including gastroenteritis)
skin infections (including cellulitis and shingles)
ear infections
oral infections (including tooth infections and cold sores)
reproductive tract infections
urinary tract infection
fungal infections
joint infections
benign tumours
skin cancer
allergic reactions (including seasonal allergy)
dehydration
mood swings (including depression)
anxiety
difficulty sleeping
sensation disorders such as tingling, prickling or numbness
migraine
nerve root compression (including low back pain and leg pain)
vision disturbances
eye inflammation
inflammation of the eye lid and eye swelling
vertigo (feeling of dizziness or spinning)
sensation of heart beating rapidly
high blood pressure
flushing
haematoma (collection of blood outside of blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heart burn)
acid reflux disease
sicca syndrome (including dry eyes and dry mouth)
itching
itchy rash
bruising
inflammation of the skin (such as eczema)
breaking of finger nails and toe nails
increased sweating
hair loss
new onset or worsening of psoriasis
muscle spasms
blood in urine
kidney problems
chest pain
oedema (swelling)
fever
reduction in blood platelets which increases risk of bleeding or bruising
impaired healing Uncommon (may affect up to 1 in 100 people)
opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
neurological infections (including viral meningitis)
eye infections
bacterial infections
diverticulitis (inflammation and infection of the large intestine)
cancer
cancer that affects the lymph system
melanoma
immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
vasculitis (inflammation of blood vessels)
tremor (shaking)
neuropathy (disorder of the nerves)
stroke
hearing loss, buzzing
sensation of heart beating irregularly such as skipped beats
heart problems that can cause shortness of breath or ankle swelling
heart attack
a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel
lung diseases causing shortness of breath (including inflammation)
pulmonary embolism (blockage in an artery of the lung)
pleural effusion (abnormal collection of fluid in the pleural space)
inflammation of the pancreas which causes severe pain in the abdomen and back
difficulty in swallowing
facial oedema (swelling of the face)
gallbladder inflammation, gallbladder stones
fatty liver
night sweats
scar
abnormal muscle breakdown
systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
sleep interruptions
impotence
inflammations Rare (may affect up to 1 in 1,000 people)
leukaemia (cancer affecting the blood and bone marrow)
severe allergic reaction with shock
multiple sclerosis
nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
heart stops pumping
pulmonary fibrosis (scarring of the lung)
intestinal perforation (hole in the intestine)
hepatitis
reactivation of hepatitis B
autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
cutaneous vasculitis (inflammation of blood vessels in the skin)
Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
facial oedema (swelling of the face) associated with allergic reactions
erythema multiforme (inflammatory skin rash)
lupus-like syndrome
angioedema (localised swelling of the skin)
lichenoid skin reaction (itchy reddish-purple skin rash)
Not known (frequency cannot be estimated from the available data)
hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
Merkel cell carcinoma (a type of skin cancer)
Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
liver failure
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
weight gain (for most patients, the weight gain was small)
Some side effects observed with 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
elevated liver enzymes Common (may affect up to 1 in 10 people)
high blood measurements for white blood cells
low blood measurements for platelets
increased uric acid in the blood
abnormal blood measurements for sodium
low blood measurements for calcium
low blood measurements for phosphate
high blood sugar
high blood measurements for lactate dehydrogenase
autoantibodies present in the blood
low blood potassium Uncommon (may affect up to 1 in 100 people)
elevated bilirubin measurement (liver blood test)
Rare (may affect up to 1 in 1,000 people)
low blood measurements for white blood cells, red blood cells and platelet count Reporting of side effects If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in 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. 170–173.

How to store it

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/carton after EXP. 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 Hukyndra pre-filled syringe may be stored at 20 °C to 25 °C for a maximum period of 30 days – be sure to protect it from light. Once removed from the refrigerator for storage at 20 °C to 25 °C, the syringe must be used within 30 days or discarded, even if it is returned to the refrigerator.
You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.
Do not use this medicine if the liquid is cloudy, discoloured, or has flakes or particles in it.
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. 173–174.

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

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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

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NetherlandsNo exact match for this strength and form

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SwitzerlandNo exact match for this strength and form

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Details

Made by	Stada Arzneimittel AG
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	2021-11-15
Last updated by the regulator	2026-07-17
EMA product number	EMEA/H/C/005548

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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