(isatuximab-irfc)
Sarclisa is a monoclonal antibody directed against the CD38 receptor on the surface of myeloma cells. This targeted anti-myeloma therapy kills myeloma cells directly and also recruits surrounding immune cells to enhance this killing process.
FDA-approved indications for Sarclisa The U.S. Food and Drug Administration (FDA) has approved Sarclisa for adult patients with myeloma as follows: ¡ In combination with the immunomodulatory agent Pomalyst® (pomalidomide) and the steroid dexameth asone (Isa-Pd) for patients who have received at least 2 prior therapies including the immunomodulatory agent Revlimid® (lenalidomide) and a proteasome inhibitor, such as Velcade® (bortezomib), Ninlaro® (ixazomib), or Kyprolis® (carfilzomib). ¡ In combination with Kyprolis and dexamethasone (Isa-Kd) for patients with relapsed or refractory myeloma who have received 1 to 3 prior lines of therapy.
Dose and schedule of Sarclisa
¡ Isa-Pd: Sarclisa is given as an intravenous (IV) infusion at a dose of 10 mg/kg once-weekly for the first 4 weeks, then once every other week. The first infusion takes about 3–4 hours, the second infusion is about 2 hours, and the subsequent infusions are typically 75 minutes. Pomalyst is taken by mouth in capsule form at a dose of 4 mg on days 1–21 of every 28-day cycle. Dexamethasone can be taken by mouth or as an IV infusion at a dose of 40 mg once-weekly, or at 20 mg once-weekly for patients over 75 years of age. ¡ Isa-Kd: Sarclisa is given as an IV infusion at a dose of 10 mg/kg once-weekly for the first 4 weeks, then once every other week. The first infusion takes about 3–4 hours, the second infusion is about 2 hours, and the subsequent infusions are typically 75 minutes. Kyprolis is administered as a once-weekly IV infusion at a dose of 20 mg/m2 in the first cycle and once every other week at 56 mg/m2 during subsequent cycles. (continues on reverse side)
Dexamethasone is administered on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle at a dose of 20 mg. It is given as an IV infusion on days of Sarclisa and/or Kyprolis and taken orally by tablet on other days.
Possible side effects
¡ Isa-Pd: The most common side effects occurring in ≥ 20% of patients include upper respiratory tract infection, infusion-related reactions, pneumonia, and diarrhea. The most common hematology laboratory abnormalities (≥ 80%) were decreased levels of hemoglobin, neutrophils, lymphocytes, and platelets. Possible serious side effects include pneumonia (26%), upper respiratory tract infections (7%), and febrile neutropenia (7%). Reported fatal adverse reactions that occurred in more than 1% of patients were pneumonia and other infections (3%). ¡ Isa-Kd: The most common side effects occurring in ≥ 20% of patients include upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, shortness of breath, insomnia, bronchitis, cough, and back pain. The most common hematology laboratory abnormalities were decreased levels of hemoglobin, lymphocytes, and platelets. Possible serious side effects include pneumonia (25%) and upper respiratory tract infections (9%). Reported fatal adverse reactions that occurred in more than 1% of patients during treatment were pneumonia (1.7%) and cardiac failure (1.1%).
Access and support resources
To explore the access and support resources for Sarclisa that may be available for eligible patients, please visit SanofiCareAssist.com/Sarclisa or call 1.833.930.2273.
Visit publications.myeloma.org to learn more about Sarclisa and other myeloma therapies. As always, the IMF urges you to discuss all medical issues with your doctor, and to contact the IMF with your myeloma questions and concerns.
International Myeloma Foundation
4400 Coldwater Canyon Ave., Ste 300 – Studio City, CA 91604 USA 1.818.487.7455 TheIMF@myeloma.org myeloma.org
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SARCLISA
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