Initial US Approval:
2020
Key Clinical Studies:
ICARIA-MM (NCT0299033); IKEMA (NCT03275285); IMROZ (NCT03319667)
Drug Class/Description:
CD38-directed cytolytic antibody
Indications and Usage:
- 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.
- 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.
- In combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
Dosage Administration:
- Premedicate with dexamethasone, acetaminophen, H2 antagonists, and diphenhydramine.
- The recommended dose of SARCLISA is 10 mg/kg as an intravenous infusion.
See full prescribing information for SARCLISA schedules of administration and drugs used in combination.
Dosage Forms and Strengths:
Injection:
- 100 mg/5 mL (20 mg/mL) solution in single-dose vial (3)
- 500 mg/25 mL (20 mg/mL) solution in single-dose vial
Contraindications:
Patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.
Warnings and Precautions:
Infusion-Related Reactions: In case of grade ≥2, interrupt SARCLISA and manage medically. Permanently discontinue for grade 4 infusion-related reactions or anaphylactic reaction.
Infections: SARCLISA can cause serious and fatal infections. Monitor patients for signs and symptoms of infection and treat appropriately.
Neutropenia: Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. SARCLISA dose delays and the use of colony-stimulating factor may be required to allow improvement of neutrophil count.
Second Primary Malignancies (SPM): Monitor patients for the development of second primary malignancies.
Laboratory Test Interference:
- Interference with Serological Testing (Indirect Antiglobulin Test): Type and screen patients prior to starting treatment. Inform blood banks that a patient has received SARCLISA.
- Interference with Serum Protein Electrophoresis and Immunofixation Tests: SARCLISA may interfere with the assays used to monitor M-protein, which may impact the determination of complete response.
Embryo-Fetal Toxicity: Can cause fetal harm.
Adverse Reactions:
- In combination with pomalidomide and dexamethasone: The most common adverse reactions (≥20%) are upper respiratory tract infection, infusion-related reactions, pneumonia, and diarrhea. The most common hematology laboratory abnormalities (≥80%) are decreased hemoglobin, decreased neutrophils, decreased lymphocytes, and decreased platelets.
- In combination with carfilzomib and dexamethasone: The most common adverse reactions (≥20%) are 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%) are decreased hemoglobin, decreased lymphocytes, and decreased platelets.
- In combination with bortezomib, lenalidomide and dexamethasone: The most common adverse reactions (≥20%) are upper respiratory tract infections, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19. The most common hematologic laboratory abnormalities (≥80%) are decreased hemoglobin, decreased leukocytes, decreased lymphocytes, decreased platelets, and decreased neutrophils.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted from:
https://products.sanofi.us/Sarclisa/sarclisa.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
