Active Ingredient: Sarilumab
Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient age in years is ≥ 2 and patient weight is ≥ 10 kg and patient weight is < 30 kg, subcutaneous, 4 milligrams sarilumab per kilogram of body weight, once every 2 weeks.
Regimen B: In case that patient age in years is ≥ 2 and patient weight is ≥ 30 kg, subcutaneous, 3 milligrams sarilumab per kilogram of body weight, once every 2 weeks.
Regimen C: In case that patient age in years is ≥ 2 and patient weight is ≥ 63 kg, subcutaneous, 200 milligrams sarilumab, once every 2 weeks.
The recommended posology in patients 2 years of age and older is 4 mg/kg subcutaneously once every 2 weeks in patients weighing 10 to less than 30 kg or 3 mg/kg subcutaneously once every 2 weeks in patients weighing greater than or equal to 30 kg.
Sarilumab can be used alone or in combination with MTX.
Sarilumab should be administered by subcutaneous injection and the dose should be calculated based on the patient’s body weight (kg) at each administration. A change in dose should only be based on a consistent change in the patient’s body weight over time.
Patients must have a minimum body weight of 10 kg when receiving sarilumab.
For patients who initially receive the 4 mg/kg dose and weigh between 27.5 to <39.5 kg, the volume of injection must be maintained until the patient reaches 39.5 kg. At 39.5 kg, the patient must transition to the 3 mg/kg dose. The dose is capped at 200 mg given once every 2 weeks for patients weighing at or above 63 kg.
Injection sites (abdomen, thigh and upper arm) should be rotated with each injection. Sarilumab should not be injected into skin that is tender, damaged, or has bruises or scars.
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