Idacio

Idacio Dosage/Direction for Use

adalimumab

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig
Full Prescribing Info
Dosage/Direction for Use
Idacio is a biosimilar medicinal product.
Substitution of Humira with Idacio should take place only under the supervision of the prescribing medical practitioner.
Idacio treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Idacio is indicated. Patients treated with Idacio should be given the patient reminder card.
After proper training in injection technique, patients may self-inject with Idacio if their physician determines that it is appropriate and with medical follow-up as necessary.
During treatment with Idacio, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Posology: Rheumatoid arthritis: The recommended dose of Idacio for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with Idacio.
Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Idacio. Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see Precautions and Pharmacology: Pharmacodynamics under Actions.
In monotherapy, some patients who experience a decrease in their response to Idacio 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period.
Dose interruption: There may be a need for dose interruption, for instance before surgery or if a serious infection occurs.
Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Ankylosing spondylitis and psoriatic arthritis: The recommended dose of Idacio for patients with ankylosing spondylitis and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period.
Psoriasis: The recommended dose of Idacio for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
Crohn's disease: The recommended Idacio induction dose regimen for adult patients with severe active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2. In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction.
After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection. Alternatively, if a patient has stopped Idacio and signs and symptoms of disease recur, Idacio may be re-administered. There is little experience from re-administration after more than 8 weeks since the previous dose.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Some patients who experience decrease in their response to Idacio 40 mg every other week may benefit from an increase in dosage to 40 mg Idacio every week.
Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12. Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Special populations: Elderly: No dose adjustment is required.
Renal and/or hepatic impairment: Adalimumab has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population: Polyarticular Juvenile Idiopathic Arthritis from 13 to 17 years of age: The recommended dose of Idacio for patients with polyarticular juvenile idiopathic arthritis, aged 13 to 17 years (with ≥ 30 kg weight) is 40 mg adalimumab administered every other week via subcutaneous injection.
Available data suggest that clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.
There is no relevant use of adalimumab in patients aged less than 2 years for this indication.
Method of administration: Idacio is administered by subcutaneous injection. Full instructions for use are provided in the package leaflet.
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