Idacio

Do not take it if

From the package leaflet in EMA’s product information, p. 73.

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.
• Idacio is injected under the skin (subcutaneous use).
• The recommended doses for Idacio in each of the approved uses are shown in the following table.
• Idacio is not available for patients that require less than 40 mg dose. If an alternative dose is required, other adalimumab products offering such an option should be used.
• 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 Idacio. If your doctor decides that methotrexate is inappropriate, Idacio can be given alone.
• If you have rheumatoid arthritis and you do not receive methotrexate with your Idacio therapy, your doctor may decide to give Idacio 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 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 Plaque psoriasis Age or body weight How much and how often to Notes take?
• Adults Initial dose of 80 mg (as two If this dose does not work well 40 mg injections in one day), enough, your doctor may followed by 40 mg given every increase the dose to 40 mg other week starting one week every week or 80 mg every after the initial dose. other week.
• You should continue to inject Idacio for as long as your doctor has told you.
• Children and adolescents from Initial dose of 40 mg, followed Not applicable 4 to 17 years of age weighing by 40 mg one week later.
• 30 kg or more Thereafter, the usual dose is 40 mg every other week.
• Hidradenitis suppurativa Age or body weight How much and how often to Notes take?
• Adults Initial dose of 160 mg (as four It is recommended that you use 40 mg injections in one day or an antiseptic wash daily on the two 40 mg injections per day affected areas.
• for two consecutive days), followed by an 80 mg dose (as two 40 mg injections on the same 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 Initial dose of 80 mg (as two If this dose does not work well years of age weighing 30 kg or 40 mg injections in one day), enough, your doctor may more followed by 40 mg every other increase the dose frequency to week starting one week later. 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 Initial dose of 80 mg (as two If this dose does not work well adults from 6 years of age 40 mg injections in one day), enough, your doctor may weighing 40 kg or more followed by 40 mg two weeks increase the dose frequency to later. 40 mg every week or 80 mg every other week.
• If a faster response is required, your doctor may prescribe an initial 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 Initial dose of 40 mg, followed If this dose does not work well 6 to 17 years of age weighing by 20 mg two weeks later. enough, your doctor may less than 40 kg increase the dose frequency to If a faster response is required, 20 mg every week.* your 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.
• * Idacio is only available as 40 mg pre-filled syringe and 40 mg pre-filled pen. Thus, it is not possible to administer Idacio to patients that require less than a full 40 mg dose.
• Ulcerative colitis Age or body weight How much and how often to Notes take?
• Adults Initial dose of 160 mg (as four If this dose does not work well 40 mg injections in one day or enough, your doctor may as two 40 mg injections per day increase the dose to 40 mg for two consecutive days), every week or 80 mg every followed by 80 mg (as two other week.
• 40 mg injections in one day)
• two weeks later.
• Thereafter, the usual dose is 40 mg every other week.
• Children and adolescents from Initial dose of 160 mg (as four Patients who turn 18 years of 6 to 17 years of age weighing 40 mg injections in one day or age while on 80 mg every other 40 kg or more two 40 mg injections per day week, should continue their for two consecutive days) prescribed dose.
• initially, followed by 80 mg (as two 40 mg injections in one day) two weeks later.
• Thereafter, the usual dose is 80 mg every other week.
• Children and adolescents from Initial dose of 80 mg (as two Patients who turn 18 years of 6 to 17 years of age weighing 40 mg injections in one day) age while on 40 mg every other less than 40 kg initially, followed by 40 mg (as week, should continue their one 40 mg injection) two weeks prescribed dose.
• later.
• Thereafter, the usual dose is 40 mg every other week.
• Non-infectious uveitis Age or body weight How much and how often to Notes take?
• Adults Initial dose of 80 mg (as two Corticosteroids or other 40 mg injections), followed by medicines that influence the 40 mg every other week immune system may be starting one week after the continued while using Idacio.
• initial dose. Idacio can also be given alone.
• You should continue to inject Idacio for as long as your doctor has told you.
• Children and adolescents from 40 mg every other week Your doctor may also prescribe 2 years of age weighing at least an initial dose of 80 mg which 30 kg may be administered one week prior to the start of the usual dose.
• Idacio is recommended for use in combination with methotrexate.
• Method and route of administration Idacio is administered by injection under the skin (by subcutaneous injection).
• Detailed instructions on how to inject Idacio are provided in section 7 ‘Instructions for use’.
• If you use more Idacio than you should If you accidentally inject Idacio more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required. Always take the outer carton of the medicine with you, even if it is empty.
• If you forget to use Idacio If you forget to give yourself an injection, you should inject the next dose of Idacio 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 Idacio The decision to stop using Idacio should be discussed with your doctor. Your 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. 77–80.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 74–76.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 76.

Other medicines

From the package leaflet in EMA’s product information, p. 76.

Driving and using machines

• Idacio may have a minor influence on your ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking Idacio.
• Idacio contains sodium This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free’.
• Idacio contains polysorbates This medicine contains 0.8 mg of polysorbate 80 in each 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. 76–77.

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 Idacio 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 (localized 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 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. 80–84.

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 Idacio pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 28 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 28 days or discarded, even if it is later 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. 84.

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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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).

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Same active substance

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