Sarclisa (isatuximab-irfc)

What Is Sarclisa?

Sarclisa® is a novel anti-CD38 monoclonal antibody. It is a type of targeted immunotherapy that is able to “find and bind” to myeloma cells. Sarclisa works together with your immune system to help destroy myeloma cells

How Does Sarclisa Work?

Sarclisa works in three distinct ways to reduce the number of myeloma cells in your body:

• It finds and binds to myeloma cells and exposes them for elimination by your immune system.
• It helps boost your immune system, making it harder for myeloma cells to survive.
• It directly kills myeloma cells.

Who is a Candidate for Sarclisa?

Sarclisa is a CD38-directed cytolytic antibody indicated: 

• in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor, or
• in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

How Is Sarclisa Administered?

Sarclisa is administered by intravenous (IV, or through the vein) infusion.

What Are the Dose and Schedule of Sarclisa Regimens?

Sarclisa (isatuximab-irfc), pomalidomide, and dexamethasone combination therapy

For Isa-Pd regimen, patients must pre-medicate with dexamethasone, acetaminophen, H2 antagonists, and diphenhydramine.
The recommended dose of Sarclisa is 10 mg/kg as an intravenous infusion every week for 4 weeks, followed by every 2 weeks until disease progression or unacceptable toxicity.

Sarclisa, Kyrpolis, and dexamethasone (SKd) combination therapy

The standard doses and schedules of the drugs in the SKd regimen are:

• Sarclisa is given as an intravenous (IV, into a vein) infusion at a dose of 10 mg/kg every week for 4 weeks, then every 2 weeks. The first and second infusions take about 3–4 hours, but the remaining 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. 
• 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 Kyprolis and taken orally by tablet on other days.

What Are Possible Side Effects of Sarclisa?

According to the indication, Sarclisa can be used as part of two regimens. The side effects for these regimens are the following:

• In combination with pomalidomide and dexamethasone: The most common adverse reactions (≥20%) were upper respiratory tract infection, infusion-related reactions, pneumonia, and diarrhea. The most common hematology laboratory abnormalities (≥80%) were decreased hemoglobin, decreased neutrophils, decreased lymphocytes, and decreased platelets. 
• In combination with carfilzomib and dexamethasone: The most common adverse reactions (≥20%) were upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain. The most common hematology laboratory abnormalities (≥80%) were decreased hemoglobin, decreased lymphocytes, and decreased platelets. 

Access to Sarclisa and Other Resources

CareASSIST by Sanofi Genzyme helps eligible patients with access and support for Sarclisa. To explore the services and resources that may be available for you, please call 1.833.930.2273 or visit https://www.sanoficareassist.com/sarclisa/.