Sarclisa

Generic Name/API: Isatuximab-irfc
Manufacturer: Sanofi-aventis U.S. LLC
Packaging: Injection form
Storage: Store at 2ºC to 8ºC
Dosage: 10 mg/kg as an intravenous infusion
Strength: 100 mg/5 mL (20 mg/mL) 500 mg/25 mL (20 mg/mL)
Indication: Isatuximab or Sarclisa is a prescription medication used in combination with Pomalidomide and dexamethasone for adults with multiple myeloma who have received multiple therapies, and carfilzomib and dexamethasone for those who have failed or are no longer effective.
No Indian generic option is available.
 
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About Isatuximab

Sarclisa or Isatuximab is a CD38-directed cytolytic antibody recommended for the treatment of adult patients with multiple myeloma who have had at least two previous treatments, including lenalidomide and a proteasome inhibitor, in combination with pomalidomide and dexamethasone.


Strength

Injection:  100 mg/5 mL (20 mg/mL) 500 mg/25 mL (20 mg/mL) 


Recommended Dosage

The recommended dosage of Sarclisa or Isatuximab is 10 mg/kg and is indicated as an intravenous infusion every week for four weeks, followed by every two weeks in combination with pomalidomide and dexamethasone until disease progression or intolerable toxicity. 

Important: If patients experience any adverse reactions from Isatuximab treatment, it is necessary to consult the treating doctor. 


Warnings & Precautions

  • Isatuximab should be interrupted and managed medically in cases of infusion-related reactions. Discontinue the treatment immediately.
  • During therapy, complete blood cell counts should be checked on a regular basis for Neutropenia. In patients with neutropenia, the consulting doctor should keep a check on the symptoms of infection. To enhance neutrophil count, SARCLISA dosage delays and the usage of colony-stimulating factors may be necessary. 
  • According to IMWG standards, patients should be monitored for the development of second primary malignancies. Laboratory test interference with serological testing and serum protein electrophoresis and immunofixation may impact complete response determination, requiring patient screening and informed blood banks.
  • Isatuximab treatment may cause fetal damage (Embryo-fetal Toxicity).

Common Isatuximab Side Effects

  • Neutropenia
  • Infusion-related reactions
  • Pneumonia
  • Upper respiratory tract infection
  • Diarrhea

Storage and Handling

One 100 mg/5 mL and 500 mg/25 mL single-dose vial in each carton.

Store in a refrigerator at 2°C to 8°C to protect from light.

We follow a four-step process to procure the medicines: 

  1. Enquiry about the medicines: You submit a request for information about the medications you require using our portal, and we process your data. Within 24 hours, a member of our Named Access Program Support will get in touch with you and provide you with all the assistance you need. 
  2. Verification Process: As we assist patients in finding medications that are not yet approved and readily available in their home countries, Sansfro must confirm the availability and approval of the medicines they need. We also check the patient’s prescription and medical information. 
  3. Sourcing the Medicine: After the verification process has been completed, our staff will contact our vast network of suppliers to find your medicine. Following the process, our team gets the best rates of the medicines for you and ensures processing. 
  4. Safe Delivery: We will set up the consignment’s safe delivery after the final quote is approved. Additionally, our logistics experts can help you track your consignment. The Named Access Program industry has a large number of unauthorized channels. To provide the medications safely and legally, we do so by adhering to the Standard Operating Procedures. 

When importing medication, we will need the following documents from the patient:

  1. A valid prescription copy.
  2. An identity proof document.
  3. Details of the attending healthcare professional.
  4. A current address.

Once we have all these documents, the Sansfro team will initiate the application process for an import license. This license is essential to ensure that we can obtain the necessary medication once it receives government approval.

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About Sansfro

Sansfro is committed to bridging the healthcare gap. Our purpose is to bring hope and healing to patients suffering from rare diseases by linking them with life-saving treatments through our Named Patient Program. Join us in our quest for a better and healthier world.

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FAQ'S

How does Isatuximab work? 

Sarclisa or Isatuximab targets and binds to the CD38 protein on the surface of myeloma cells. It also aids the immune system in identifying and attacking cancer cells.

Is Isatuximab a chemotherapy medication? 

Sarclisa or Isatuximab is not a chemotherapy medication. It is classified as a targeted treatment and belongs to the family of drugs known as monoclonal antibodies.

What is Isatuximab used for? 

Sarclisa or Isatuximab is used to treat adult patients with relapsed or refractory multiple myeloma who have had at least two previous treatments, including lenalidomide and a proteasome inhibitor.

How to administer Isatuximab? 

The consulting doctor administers Sarclisa by intravenous infusion. He/She will decide on the appropriate dose and infusion regimen.

What are the common Isatuximab side effects? 

Fatigue, infusion-related responses, upper respiratory tract infections, diarrhea, and reduced appetite are common Sarclisa side effects. It’s critical to address any adverse effects with the consulting doctor.

Can Sarclisa be used to treat multiple myeloma? 

Sarclisa is not a cure-all for multiple myeloma. It is used to treat individuals who have not reacted well to earlier therapies and control the condition and enhance results.

Are there any specific tests required before starting Sarclisa treatment? 

Yes, various tests may be performed by the doctor to examine a patient’s general health and establish eligibility for Sarclisa treatment. These tests may include blood testing, imaging investigations, and organ function assessments.

Is Isatuximab available in India? 

Sarclisa is approved for the treatment of relapsed or refractory multiple myeloma in India.

What should I discuss with my doctor before taking Sarclisa? 

It is necessary to discuss your medical history, current medications, and any underlying health issues with your healthcare professional before beginning Sarclisa treatment. They will advise on the best treatment approach for your specific situation. 

What is the price of Isatuximab in India?

Isatuximab price in India depends on the product requirement. Request more details by reaching out to our Patient Support Team at ‎(+91) 93157 05373 or help@sansfro.com 

Dr Anchal Aryan

Medical counselor

Patient Support Head Detail

Dr Anchal Aryan

Medical counselor

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