Active Ingredient: Isatuximab
Isatuximab is indicated:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 10 milligrams isatuximab per kilogram of body weight, once weekly. This step is repeated 4 times. Afterwards, intravenous, 10 milligrams isatuximab per kilogram of body weight, once every 2 weeks.
Premedication should be used prior to isatuximab infusion with the following medicinal products to reduce the risk and severity of infusion reactions:
The above recommended dose of dexamethasone (oral or intravenous) corresponds to the total dose to be administered only once before the infusion, as part of the premedication and the backbone treatment, before isatuximab and pomalidomide and before isatuximab and carfilzomib administration.
The recommended premedication agents should be administered 15-60 minutes prior to starting a isatuximab infusion. Patients who do not experience an infusion reaction upon their first 4 administrations of isatuximab may have their need for subsequent premedication reconsidered.
The use of colony-stimulating factors (e.g. G-CSF) should be considered to mitigate the risk of neutropenia. In the event of grade 4 neutropenia, isatuximab administration should be delayed until neutrophil count improves to at least 1.0 × 109/L.
Antibacterial and antiviral prophylaxis (such as herpes zoster prophylaxis) can be considered during treatment.
The recommended dose of isatuximab is 10 mg/kg body weight administered as an intravenous infusion in combination with pomalidomide and dexamethasone (Isa-Pd) or in combination with carfilzomib and dexamethasone (Isa-Kd), according to the schedule in Table 1.
Table 1. Isatuximab dosing schedule in combination with pomalidomide and dexamethasone or in combination with carfilzomib and dexamethasone:
| Cycles | Dosing schedule |
|---|---|
| Cycle 1 | Days 1, 8, 15 and 22 (weekly) |
| Cycle 2 and beyond | Days 1, 15 (every 2 weeks) |
Each treatment cycle consists of a 28-day period. Treatment is repeated until disease progression or unacceptable toxicity.
For other medicinal products that are administered with isatuximab, see the respective current summary of product characteristics.
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 (see “Method of administration” below).
For other medicinal products that are administered with isatuximab, the respective current summary of product characteristics should be considered.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
