Active Ingredient: Isatuximab
Isatuximab is indicated in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 10 milligrams isatuximab per kilogram of body weight, once weekly, 5 doses in total, over the duration of 42 days. Afterwards, intravenous, 10 milligrams isatuximab per kilogram of body weight, once every 2 weeks, 3 doses in total, over the duration of 42 days. This step is repeated 3 times. Afterwards, intravenous, 10 milligrams isatuximab per kilogram of body weight, once every 2 weeks, 2 doses in total, over the duration of 28 days. This step is repeated 13 times. Afterwards, intravenous, 10 milligrams isatuximab per kilogram of body weight, once every 4 weeks.
The recommended dose of isatuximab is 10 mg/kg body weight administered as an intravenous infusion in combination with bortezomib, lenalidomide, and dexamethasone (Isa-VRd).
Isatuximab dosing schedule in combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) (IMROZ):
| Cycles | Dosing schedule |
|---|---|
| Cycle 1 (42-day cycle) | Days 1, 8, 15, 22, and 29 |
| Cycles 2 to 4 (42-day cycles) | Days 1, 15, and 29 (every 2 weeks) |
| Cycles 5 to 17 (28-day cycles) | Days 1 and 15 (every 2 weeks) |
| Cycles 18 and beyond (28-day cycles) | Days 1 (every 4 weeks) |
Each treatment cycle consists of a 42-day period from cycle 1 to 4, and of a 28-day period from cycle 5. 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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