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Sarclisa

Sarclisa

Manufacturer:

Sanofi-Aventis Deutschland
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Core Prescribing Info
Contents
Isatuximab
Indications/Uses
In combination w/ pomalidomide & dexamethasone for adult patients w/ relapsed & refractory multiple myeloma who have received at least 2 prior therapies including lenalidomide & a proteasome inhibitor & have demonstrated disease progression on the last therapy; w/ carfilzomib & dexamethasone for adult patients w/ relapsed or refractory multiple myeloma who have received 1-3 prior therapies; w/ bortezomib, lenalidomide & dexamethasone for adult patients w/ newly diagnosed active multiple myeloma who are not eligible for autologous stem cell transplant.
Dosage/Direction for Use
Premed Administer 15-60 min prior to starting Sarclisa infusion. Dexamethasone 40 mg PO or IV (or 20 mg PO or IV for patients ≥75 yr) when administered in combination w/ isatuximab & pomalidomide. Dexamethasone 20 mg (IV on the days of isatuximab &/or carfilzomib infusions, & PO on the other days) when administered in combination w/ isatuximab & carfilzomib. Acetaminophen 650-1,000 mg PO (or equiv). Diphenhydramine 25-50 mg IV or PO [or equiv (eg, cetirizine, promethazine, dexchlorpheniramine)]. Adult In combination w/ pomalidomide & dexamethasone or w/ carfilzomib & dexamethasone 10 mg/kg IV infusion wkly for cycle 1 (days 1, 8, 15 & 22) then every 2 wk for cycle 2 & beyond (days 1 & 15); repeat until disease progression or unacceptable toxicity. In combination w/ bortezomib, lenalidomide & dexamethasone Sarclisa 10 mg/kg IV infusion wkly for cycle 1 (days 1, 8, 15, 22 & 29); every 2 wk for cycles 2-4 (days 1, 15 & 29) & cycles 5-17 (days 1 & 15) then every 4 wk for cycle 18 (day 1) until disease progression or unacceptable toxicity. Bortezomib 1.3 mg/m2 SC administered on days 1, 4, 8, 11, 22, 25, 29 & 32 of cycles 1-4. Lenalidomide 25 mg PO daily given on days 1-14 & 22-35 of cycles 1-4 & on days 1-21 for cycle 5-18 & thereafter. Dexamethasone 20 mg daily as IV on Sarclisa infusion days & PO on other days given in cycles 1-4 for patients <75 yr (days 1, 2, 4, 5, 8, 9, 11, 12, 15, 22, 23, 25, 26, 29, 30, 32 & 33) & for patients ≥75 yr (days 1, 4, 8, 11, 15, 22, 25, 29 & 32), then once wkly on days 1, 8, 15 & 22 from cycle 5-17 & thereafter for both age groups. Each treatment cycle consists of 28-day period.
Contraindications
Hypersensitivity.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FC02 - isatuximab ; Belongs to the class of CD38 (Clusters of Differentiation 38) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Sarclisa conc for soln for infusion 20 mg/mL
Packing/Price
1's
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