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After proper training in injection technique, patients may self-inject with AMGEVITA if their physician determines that it is appropriate and with medical follow-up as necessary.
During treatment with AMGEVITA, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Posology: Rheumatoid arthritis: The recommended dose of AMGEVITA 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 AMGEVITA.
Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with AMGEVITA. 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 AMGEVITA 40 mg every other week may benefit from an increase in dose to 40 mg adalimumab every week or 80 mg every other week.
Available adalimumab 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, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis: The recommended dose of AMGEVITA for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS 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 AMGEVITA 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.
Beyond 16 weeks, patients with inadequate response to AMGEVITA 40 mg every other week may benefit from an increase in dose to 40 mg every week or 80 mg every other week. The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dose (see Pharmacology: Pharmacodynamics under Actions). If adequate response is achieved with 40 mg every week or 80 mg every other week, the dose may subsequently be reduced to 40 mg every other week.
Crohn's disease: The recommended AMGEVITA induction dose regimen for adult patients with moderately to severely 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), followed by 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 AMGEVITA and signs and symptoms of disease recur, AMGEVITA 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 AMGEVITA 40 mg every other week may benefit from an increase in dosage to 40 mg AMGEVITA every week or 80 mg every other 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.
Ulcerative colitis: The recommended AMGEVITA induction dose regimen for adult patients with moderate to severe ulcerative colitis is 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) and 80 mg at week 2 (given as two 40 mg injections in one day). After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Some patients who experience decrease in their response to AMGEVITA 40 mg every other week may benefit from an increase in dose to 40 mg AMGEVITA every week or 80 mg every other week.
Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment.
AMGEVITA therapy should not be continued in patients failing to respond 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: Juvenile idiopathic arthritis: Polyarticular juvenile idiopathic arthritis: Children, adolescents and adults from 2 years of age weighing 30 kg or more: The recommended dose of AMGEVITA for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (see Table 22). AMGEVITA is administered every other week via subcutaneous injection.
Click on icon to see table/diagram/imageAvailable clinical 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.
Paediatric Crohn's disease: Children and adolescents from 6 to 17 years of age weighing 40 kg or more: The recommended dose of AMGEVITA for patients with Crohn's disease from 6 to 17 years of age is based on body weight (see Table 23). AMGEVITA is administered via subcutaneous injection.
Click on icon to see table/diagram/imagePatients who experience insufficient response may benefit from an increase in dose: ≥ 40 kg: 40 mg every week or 80 mg every other week.
Continued therapy should be carefully considered in a subject not responding by week 12.
There is no relevant use of adalimumab in children aged less than 6 years for this indication.
Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis: There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Method of administration: AMGEVITA is administered by subcutaneous injection. Full instructions for use are provided in the package leaflet.
