AMGEVITA^® DOSING¹

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 sections 4.4 and 5.1 of the Summary of Product Characteristics.

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 intensity 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.

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.

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.

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 dosing frequency 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 dosage (see section 5.1 of the Summary of Product Characteristics). If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.

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 or 80 mg every other week (given as two 40 mg injections in one day). 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 or 80 mg every other week may be re-introduced (see section 5.1 of the Summary of Product Characteristics).

The benefit and risk of continued long-term treatment should be periodically evaluated (see section 5.1 of the Summary of Product Characteristics).

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), 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.

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 ^® 40 mg every other week may benefit from an increase in dosage to 40 mg AMGEVITA^® every week or 80 mg every other 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.

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 section 5.1 of the Summary of Product Characteristics).

No dose adjustment is required.

Adalimumab has not been studied in these patient populations. No dose recommendations can be made.

AMGEVITA^® is only available as 20 mg and 40 mg pre-filled syringe and 40 mg pre-filled pen. 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.

Refer to the Summary of Product Characteristics for further information on the recommended doses of AMGEVITA^® for paediatric indications. The recommended doses for paediatric populations are based on body weight.