All about Sarclisa

Introduction

Sarclisa, with its active ingredient, Isatuximab-irfc, is a significant advancement in treating multiple myeloma. The FDA approved this medicine; it has rapidly become an invaluable addition to the arsenal of medications to combat this challenging cancer. 

FDA Approval and Manufacturer Details

Sarclisa Sanofi received FDA approval in March 2020, signifying a major milestone in treating multiple myeloma. This groundbreaking medication is manufactured by Sanofi, a leading pharmaceutical company renowned for its commitment to research and development in oncology.

Uses and Indications

Sarclisa is approved for treating adult patients with multiple myeloma who have relapsed or are refractory after receiving a minimum of two prior therapies, including a proteasome inhibitor and lenalidomide. This monoclonal antibody therapy enhances the immune system’s ability to combat myeloma cells.

Mechanism of Action 

Sarclisa is a monoclonal antibody that binds to CD38, a protein on myeloma cells. It directly destroys these cells, boosts the immune response against them, and inhibits their growth, making it effective in treating multiple myeloma.

Dosage and Administration Information

To ensure patient safety, Sarclisa injection requires premedication, involving dexamethasone, acetaminophen, H2 antagonists, and diphenhydramine. The recommended dosage for Sarclisa is 10mg/kg, administered via intravenous infusion. This regimen commences with weekly infusions for 4 weeks, followed by bi-weekly infusions when combined with pomalidomide and dexamethasone, and it continues until disease progression or unacceptable toxicity. Sarclisa is available as an injectable solution in two strengths: 100mg/5 mL and 500mg/25 mL, both as single-dose vials.

Warnings and Precautions

Sarclisa is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or any of its components. Several warnings and precautions apply, including managing and potentially discontinuing Sarclisa in the event of infusion-related reactions with a severity of grade ≥3. Regular monitoring of complete blood cell counts is necessary during treatment, particularly in patients with neutropenia, and the use of colony-stimulating factors may be required for improving neutrophil count. 

Second primary malignancies should be monitored following IMWG guidelines. Sarclisa may interfere with serological testing, so blood typing should be performed before treatment, and blood banks should be informed of Sarclisa use. Additionally, Sarclisa can impact serum protein electrophoresis and immunofixation tests, potentially affecting the determination of complete response. Due to the risk of fetal harm, breastfeeding is not advised during this treatment.

Recent Research and Ongoing Studies

As the world of oncology continues to evolve, Sarclisa is the focus of ongoing research. Recent studies have explored its efficacy in various settings, including combination therapies. Researchers are keen on further understanding its role in treating multiple myeloma, aiming to improve patient outcomes.

Some Side Effects

Common side effects of Sarclisa may include upper respiratory tract infections, infusion-related reactions, diarrhea, and pneumonia. These effects should be discussed with healthcare providers to ensure appropriate management.

Clinical Trials

The FDA approval of Sarclisa was largely based on data from the pivotal ICARIA-MM study, demonstrating its efficacy in combination with pomalidomide and dexamethasone. Clinical trials involving Sarclisa have yielded promising results, with ongoing investigations to explore its potential across different patient populations and treatment scenarios.

Conclusion

Sarclisa’s FDA approval, manufactured by Sanofi, is a significant advancement in multiple myeloma treatment for patients with relapses or refractory cases. Its recommended dosage and ongoing research contribute to the evolving landscape of myeloma therapy. Sarclisa represents innovation in oncology, providing hope for improved patient outcomes. The drug’s price in India varies depending on product requirements. Sarclisa price in India depends on the product requirement. Request more details by contacting our Patient Support Team at ‎(+91) 93157 05373 or help@sansfro.com.

Reference

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf
2. https://www.sarclisa.com/
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8497289/