Sarclisa Isatuximab-irfc Injection
Sarclisa (isatuximab-irfc) is a CD38 directed cytolytic antibody used, in combination with pomalidomide and dexamethasone, to treat adult patients with multiple myeloma who have received at least a couple of prior therapies including lenalidomide and a proteasome inhibitor.
Dosage: The recommended dose of Isatuximab is 10 mg/kg actual body weight administered as an intravenous infusion in combination with medicine pomalidomide and dexamethasone. During Cycle-1, it is given on Days 1, 8, 15, and 22 (weekly), and during Cycle-2 and beyond it is given on Days 1, 15 (every 2 weeks). Each treatment cycle consists of a 28-day period. Treatment is repeated until the disease is progressive or unacceptable toxicity occurs. 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.
Side Effects: The most commonly reported sarclisa side effects (incidence ≥ 20%) include:
- infusion-related reactions
- upper respiratory tract infection
Warnings and Precautions:
- In order to reduce the risk and severity of infusion-related reactions, premedicate patients prior to sarclisa 100 mg / 500 mg infusion with acetaminophen, H2 antagonists, diphenhydramine, or equivalent; dexamethasone.
- Monitor patients with sarclisa 500 mg / 100 mg for complete blood cell counts periodically during therapy. Consider the use of antibiotics as well as antiviral prophylaxis while on therapy.
- Permanently discontinue Isatuximab therapy if a grade 3 or higher infusion-related reaction occurs and institute apt medical management.
- Monitor patients with sarclisa dosage for the development of second primary malignancies, as per International Myeloma Working Group (IMWG) guidelines.
- Women of the potential hazard to a fetus should avoid becoming pregnant during treatment and for at least 5 months following the last dose of sarclisa multiple myeloma medication.
- Respective nursing women receiving treatment with Isatuximab injection should avoid breastfeeding during the course of treatment.