Yuflyma

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 Yuflyma in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Yuflyma if you need a different dose.
• Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight How much and how often to Notes take?
• Adults 40 mg every other week In rheumatoid arthritis, methotrexate is continued while using Yuflyma. If your doctor decides that methotrexate is inappropriate, Yuflyma can be given alone.
• If you have rheumatoid arthritis and you do not receive methotrexate with your Yuflyma therapy, your doctor may decide to give Yuflyma 40 mg every week or 80 mg every other week.
• Polyarticular juvenile idiopathic arthritis Age or body weight How much and how often to Notes take?
• Children, adolescents and 40 mg every other week Not applicable adults from 2 years of age weighing 30 kg or more Children and adolescents 20 mg every other week Not applicable 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 Notes take?
• Children, adolescents and 40 mg every other week Not applicable adults from 6 years of age weighing 30 kg or more Children and adolescents 20 mg every other week Not applicable from 6 years of age weighing 15 kg to less than 30 kg Plaque psoriasis Age or body weight How much and how often to Notes take?
• Adults First dose of 80 mg (two 40 mg If you have an inadequate injections in one day), followed response, your doctor may by 40 mg every other week increase the dosage to 40 mg starting one week after the first every week or 80 mg every dose. other week.
• Children and adolescents First dose of 40 mg, followed by Not applicable from 4 to 17 years of age 40 mg one week later.
• weighing 30 kg or more Thereafter, the usual dose is 40 mg every other week.
• Children and adolescents First dose of 20 mg, followed by Not applicable from 4 to 17 years of age 20 mg one week later.
• weighing 15 kg to less than 30 kg Thereafter, the usual dose is 20 mg every other week.
• Hidradenitis suppurativa Age or body weight How much and how often to Notes take?
• Adults First dose of 160 mg (four 40 mg It is recommended that you injections in one day or two use an antiseptic wash daily 40 mg injections per day for two on the affected areas.
• consecutive days), followed by an 80 mg dose (two 40 mg injections in one day) two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
• Adolescents from 12 to 17 First dose of 80 mg (two 40 mg If you have an inadequate years of age weighing 30 kg injections in one day), followed response to Yuflyma 40 mg or more by 40 mg every other week every other week, your starting one week later.
• doctor may increase the dosage to 40 mg every week or 80 mg every other week.
• It is recommended that you use an antiseptic wash daily on the affected areas.
• Crohn’s disease Age or body weight How much and how often to Notes take?
• Children, adolescents and First dose of 80 mg (two 40 mg Your doctor may increase the adults from 6 years of age injections in one day), followed dosage to 40 mg every week weighing 40 kg or more by 40 mg two weeks later. or 80 mg every other week.
• If a faster response is required, the doctor may prescribe a first dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later.
• Thereafter, the usual dose is 40 mg every other week.
• Children and adolescents First dose of 40 mg, followed by Your doctor may increase the from 6 to 17 years of age 20 mg two weeks later. dosage to 20 mg every week.
• weighing less than 40 kg If a faster response is required, the doctor may prescribe a first dose of 80 mg (two 40 mg injections in one day) followed by 40 mg two weeks later.
• Thereafter, the usual dose is 20 mg every other week.
• Ulcerative colitis Age or body weight How much and how often to Notes take?
• Adults First dose of 160 mg (four 40 Your doctor may increase the mg injections in one day or two dosage to 40 mg every week 40 mg injections per day for two or 80 mg every other week.
• consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later.
• Thereafter, the usual dose is 40 mg every other week.
• Children and adolescents First dose of 80 mg (two 40 mg You should continue taking from 6 years of age injections in one day), followed Yuflyma at your usual dose, weighing less than 40 kg by 40 mg (one 40 mg injection) even after turning 18 years of two weeks later. age.
• Thereafter, the usual dose is 40 mg every other week Children and adolescents First dose of 160 mg (four 40 mg You should continue taking from 6 years of age injections in one day or two 40 Yuflyma at your usual dose, weighing 40 kg or more mg injections per day for two even after turning 18 years of consecutive days), followed by age.
• 80 mg (two 40 mg injections in one day) two weeks later.
• Thereafter, the usual dose is 80 mg every other week.
• Non-infectious uveitis Age or body weight How much and how often to Notes take?
• Adults First dose of 80 mg (two 40 mg Corticosteroids or other injections in one day), followed medicines that influence the by 40 mg every other week immune system may be starting one week after the first continued while using dose. Yuflyma.
• Yuflyma can also be given alone.
• Children and adolescents 20 mg every other week Your doctor may prescribe an from 2 years of age initial dose of 40 mg to be weighing less than 30 kg administered one week prior to the start of the usual dose of 20 mg every other week.
• Yuflyma is recommended for use in combination with methotrexate.
• Children and adolescents 40 mg every other week Your doctor may prescribe an from 2 years of age initial dose of 80 mg to be weighing at least 30 kg administered one week prior to the start of the usual dose of 40 mg every other week.
• Yuflyma is recommended for use in combination with methotrexate.
• Method and route of administration Yuflyma is administered by injection under the skin (by subcutaneous injection).
• Detailed instructions on how to inject Yuflyma are provided in section 7 ‘Instructions for use’.
• If you use more Yuflyma than you should If you accidentally inject Yuflyma more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that you have taken more. Always take the outer carton of the medicine with you, even if it is empty.
• If you forget to use Yuflyma If you forget to give yourself an injection, you should inject the next dose of Yuflyma as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.
• If you stop using Yuflyma The decision to stop using Yuflyma should be discussed with your doctor. Your symptoms may return if you stop using Yuflyma.
• 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. 180–184.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 177–179.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 180.

Other medicines

From the package leaflet in EMA’s product information, p. 179–180.

Driving and using machines

• Yuflyma may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Yuflyma.
• Yuflyma contains sodium This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 mL dose, i.e. essentially ‘sodium-free’.
• Yuflyma contains polysorbate This medicine contains 0.4 mg of polysorbate 80 (E433) in each 40 mg dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

From the package leaflet in EMA’s product information, p. 180.

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 Yuflyma 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 Yuflyma.
• 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 Yuflyma 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 you get 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. 184–188.

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/carton after EXP.
• Store in a refrigerator (2°C – 8°C). Do not freeze.
• Keep the pre-filled syringe with needle guard in the outer carton in order to protect from light.
• Alternative Storage:
• When needed (for example when you are travelling), a single Yuflyma pre-filled syringe with needle guard may be stored at room temperature (up to 25°C) for a maximum period of 31 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within 31 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 throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

From the package leaflet in EMA’s product information, p. 188–189.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

• The other ingredients are acetic acid, sodium acetate trihydrate, glycine, polysorbate 80 (E433), and water for injections.
• What the Yuflyma pre-filled syringe with needle guard looks like and contents of the pack Yuflyma 40 mg solution for injection in pre-filled syringe with needle guard is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.4 ml solution.

From the package leaflet in EMA’s product information, p. 189.

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

Details

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).

Report wrong or outdated information on this page

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Adalimumab