Dosing lmraldi™

The recommended dose of Imraldi™ (adalimumab) 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 lmraldi™ (adalimumab).

Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), or analgesics can be continued during treatment with lmraldi™ (adalimumab). Regarding combination with disease modifying anti rheumatic drugs other than methotrexate see sections 4.4 and 5.1 of the SmPC.

In monotherapy, some patients who experience a decrease in their response to Imraldi™ (adalimumab) 40 mg every other week dosing may benefit from an increase in dose to 40 mg adalimumab every week or 80 mg every other 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.

The recommended dose of Imraldi™ (adalimumab) 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 lmraldi™ (adalimumab) 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 lmraldi™ (adalimumab) 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 section 5.1 of Summary of Product Characteristics). 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.

The recommended lmraldi™ (adalimumab) 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 lmraldi™ (adalimumab) 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 lmraldi™ (adalimumab).

Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.

Should treatment be interrupted, lmraldi™ (adalimumab) 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1 of Summary of Product Characteristics).

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

The recommended lmraldi™ (adalimumab) 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 lmraldi™ (adalimumab) and signs and symptoms of disease recur, lmraldi™ 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 lmraldi™ (adalimumab) 40 mg every other week may benefit from an increase in dose to 40 mg lmraldi™ (adalimumab) 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 lmraldi™ (adalimumab) 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 lmraldi™ (adalimumab) 40 mg every other week may benefit from an increase in dose to 40 mg lmraldi™ (adalimumab) every week or 80 mg every other week.

Available data suggest that the clinical response is usually achieved within 2-8 weeks of treatment. lmraldi™ (adalimumab) therapy should not be continued in patients failing to respond within this time period.

The recommended dose of lmraldi™ (adalimumab) 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 lmraldi™ alone. Treatment with lmraldi™ (adalimumab) 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 lmraldi™ (adalimumab).

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 Summary of Product Characteristics).

Polyarticular juvenile idiopathic arthritis from 2 years of age

The recommended dose of lmraldi™ (adalimumab) for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight.

lmraldi™ is 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.

Enthesitis-related arthritis from 6 years of age

The recommended dose of lmraldi™ (adalimumab) for patients with enthesitis-related arthritis from 6 years of age is based on body weight.

lmraldi™ is administered every other week via subcutaneous injection.

Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.

* lmraldi™ pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer lmraldi (adalimumab) pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

The recommended dose of lmraldi™ (adalimumab) for patients from 4 to 17 years of age with paediatric plaque psoriasis is based on body weight.

Imraldi™ (adalimumab) is administered via subcutaneous injection.

Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.

lf retreatment with lmraldi™ is indicated, the above 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.

There is no relevant use of adalimumab in children aged less than 4 years for this indication.

* lmraldi™ pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer lmraldi (adalimumab) pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

There are no clinical trials with adalimumab in adolescent patients with HS. The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2 of the Summary of Product Characteristics).

The recommended lmraldi™ dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection.

ln adolescent patients with inadequate response to lmraldi™ 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.

Antibiotics may be continued during treatment with lmraldi™ if necessary. lt is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with lmraldi™.

Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.

Should treatment be interrupted, lmraldi™ (adalimumab) may be re-introduced as appropriate.

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

There is no relevant use of adalimumab in children aged less than 12 years in this indication.

The recommended dose of Imraldi™ (adalimumab) for patients with Crohn’s disease from 6 to 17 years of age is based on body weight.

lmraldi™ (adalimumab) is administered via subcutaneous injection

Patients who experience insufficient response may benefit from an increase in dosage:

• <40 kg: 20 mg every week*
• ≥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 below 6 years for this indication.

* lmraldi pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer lmraldi (adalimumab) pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

The recommended dose of Imraldi™ (adalimumab) for patients from 6 to 17 years of age with ulcerative colitis is based on body weight.

lmraldi™ (adalimumab) is administered via subcutaneous injection.

* Paediatric patients who turn 18 years of age while on lmraldi™ should continue their prescribed maintenance dose.

Continued therapy beyond 8 weeks should be carefully considered in patients not showing signs of response within this time period.

There is no relevant use of of lmraldi™ (adalimumab) in children aged less than 6 years in this indication.

• lmraldi™ (adalimumab) may be available in different strengths and/or presentations depending on the individual needs. treatment needs.

There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatric arthritis.

The recommended dose of Imraldi™ (adalimumab) for paediatric patients with uveitis from 2 years of age is based on body weight.

lmraldi™ (adalimumab) is administered via subcutaneous injection.

ln paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment with methotrexate.

When lmraldi™ therapy is initiated, a loading dose of 40 mg for patients <30 kg or 80 mg for patients ≥30 kg may be administered one week prior to the start of maintenance therapy. No clinical data are available on the use of an adalimumab loading dose in children <6 years of age (see section 5.2 of the Summary of Product Characteristics).

There is no relevant use of adalimumab in children aged less than 2 years in this indication.

lt 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).

* lmraldi™ pre-filled syringe and pre-filled pen are only available as a 40 mg dose. Thus, it is not possible to administer lmraldi (adalimumab) pre-filled syringe and pre-filled pen to paediatric patients that require less than a full 40 mg dose. If an alternative dose is required, other presentations offering such an option should be used.

No dose adjustment is required.

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