Amgevita Dosage/Direction for Use

AMGEVITA treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which AMGEVITA is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with AMGEVITA (see Precautions). Patients treated with AMGEVITA should be given the Patient Reminder Card.
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 may benefit from an increase in dose intensity to 40 mg adalimumab every 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.
Re-introduction of AMGEVITA after discontinuation for 70 days or longer should result 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.
For all of the above indications, available data suggest that the 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.
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 may benefit from an increase in dosing frequency to 40 mg every week. The benefits and risks of continued weekly therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosing frequency (see Pharmacology: Pharmacodynamics under Actions). If adequate response is achieved with an increased dosing frequency, the dose may subsequently be reduced to 40 mg every other week.
Hidradenitis suppurativa: The recommended AMGEVITA dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (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 two weeks later at day 15 (given as two 40 mg injections in one day). Two weeks later (day 29) continue with a dose of 40 mg every week.
Antibiotics may be continued during treatment with AMGEVITA if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with AMGEVITA.
Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Should treatment be interrupted, AMGEVITA 40 mg every week may be re-introduced (see Pharmacology: Pharmacodynamics under Actions).
The benefit and risk of continued long-term treatment should be periodically evaluated (see Pharmacology: Pharmacodynamics under Actions).
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 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, 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 may benefit from an increase in dosing frequency to 40 mg AMGEVITA 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.
Ulcerative colitis: The recommended AMGEVITA induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days) and 80 mg at week 2. 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 may benefit from an increase in dosing frequency to 40 mg AMGEVITA every week.
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.
Uveitis: The recommended dose of AMGEVITA for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. There is limited experience in the initiation of treatment with adalimumab alone. Treatment with AMGEVITA can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with AMGEVITA.
It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see Pharmacology: Pharmacodynamics under Actions).
Elderly patients: No dose adjustment is required.
Impaired renal and/or hepatic function: Adalimumab has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population: AMGEVITA is only available as 20 mg and 40 mg. It is not possible to administer AMGEVITA to paediatric patients that require less than a full 20 mg or 40 mg dose. If an alternate dose is required, other adalimumab products offering such an option should be used.
Polyarticular juvenile idiopathic arthritis from 2 to 12 years of age: The recommended dose of AMGEVITA for patients with polyarticular juvenile idiopathic arthritis, aged 2-12 years, is 24 mg/m² body surface area up to a maximum single dose of 20 mg adalimumab (for patients aged 2-< 4) and up to a maximum single dose of 40 mg adalimumab (for patients aged 4-12) administered every other week via subcutaneous injection. The administered dose is selected based on the patients' height and weight (Table 22). (See Table 22.)

Click on icon to see table/diagram/image

Polyarticular juvenile idiopathic arthritis from 13 years of age: For patients from 13 years of age, a dose of 40 mg is administered every other week regardless of body surface area.
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.
Enthesitis-related arthritis: The recommended dose of AMGEVITA for patients with enthesitis-related arthritis 6 years of age and older is 24 mg/m² body surface area up to a maximum single dose of 40 mg adalimumab administered every other week via subcutaneous injection. The volume for injection is selected based on the patients' height and weight (Table 22).
Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Paediatric plaque psoriasis: The recommended AMGEVITA dose is 0.8 mg per kg body weight (up to a maximum of 40 mg per dose) administered subcutaneously weekly for the first two doses and every other week thereafter.
Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
If retreatment with AMGEVITA is indicated, the previously mentioned guidance on dose and treatment duration should be followed.
The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
Patients above 4 years of age but with a weight less than 23 kg or between 29 and 46 kg are not possible to dose with this product. There is no relevant use of adalimumab in children aged less than 4 years in this indication.
The administered dose is selected based on the patients' weight (Table 23). (See Table 23.)

Click on icon to see table/diagram/image

Paediatric Crohn's disease: Paediatric Crohn's disease patients < 40 kg: The recommended AMGEVITA induction dose regimen for paediatric subjects with severe Crohn's disease is 40 mg at week 0 followed by 20 mg at week 2. In case there is a need for a more rapid response to therapy, the regimen 80 mg at week 0 (dose can be administered as two injections in one day), 40 mg at week 2 can be used, with the awareness that the risk for adverse events may be higher with use of the higher induction dose.
After induction treatment, the recommended dose is 20 mg every other week via subcutaneous injection. Some subjects who experience insufficient response may benefit from an increase in dosing frequency to 20 mg AMGEVITA every week.
Paediatric Crohn's disease patients ≥ 40 kg: The recommended AMGEVITA induction dose regimen for paediatric subjects with severe 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 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2 can be used, with the awareness that the risk for adverse events may be higher with use of the higher induction dose.
After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection. Some subjects who experience insufficient response may benefit from an increase in dosing frequency to 40 mg AMGEVITA every 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 in this indication.
Paediatric hidradenitis suppurativa: The safety and efficacy of adalimumab in children aged 12-17 years have not yet been established for hidradenitis suppurativa. No data are available. There is no relevant use of adalimumab in children aged below 12 years in this indication.
Paediatric ulcerative colitis: The safety and efficacy of adalimumab in children aged 4-17 years have not yet been established. No data are available. There is no relevant use of adalimumab in children aged < 4 years in this indication.
Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis: There is no relevant use of adalimumab in the paediatric population in the indications, ankylosing spondylitis and psoriatic arthritis.
Paediatric uveitis: The safety and efficacy of adalimumab in children aged 2-17 years have not yet been established. No data are available.
Method of administration: AMGEVITA is administered by subcutaneous injection.
A 20 mg and 40 mg are available for patients to administer a full 20 mg or 40 mg dose.