Active Ingredient: Isatuximab
Isatuximab is indicated in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 10 milligrams isatuximab per kilogram of body weight, once weekly, 4 doses in total, over the duration of 28 days. Afterwards, intravenous, 10 milligrams isatuximab per kilogram of body weight, once every 2 weeks.
The recommended dose of isatuximab is 10 mg/kg body weight administered as an intravenous infusion in combination with carfilzomib and dexamethasone (Isa-Kd).
Isatuximab dosing schedule in combination with carfilzomib and dexamethasone:
| Cycles | Dosing schedule |
|---|---|
| Cycle 1 (28-day cycle) | Days 1, 8, 15 and 22 (weekly) |
| Cycle 2 and beyond (28-day cycle) | Days 1, 15 (every 2 weeks) |
Each treatment cycle consists of a 28-day period. Treatment is repeated until disease progression or unacceptable toxicity.
The administration schedule must be carefully followed. If a planned dose of isatuximab is missed, administer the dose as soon as possible and adjust the treatment schedule accordingly, maintaining the treatment interval.
No dose reduction of isatuximab is recommended.
Administration adjustments should be made if patients experience infusion reactions, or in case of Grade 3 or 4 neutropenia, or febrile neutropenia and/or neutropenic infection.
For other medicinal products that are administered with isatuximab, the respective current summary of product characteristics should be considered.
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