Tecvayli (Teclistamab)

Indication and Usage:

The FDA approves Teclistamab to treat patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. 

Dosage and Administration

• Healthcare professionals recommend administering Teclistamab subcutaneously. 
  
• The recommended dosage of Tecvayli is step-up doses of 0.06 mg/kg and 0.3 mg/kg followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity. 
  
• One should administer pretreatment medications prior to each dose of the Teclistamab step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose.
  
• Administer Teclistamab subcutaneously according to the step-up dosing schedule to reduce the incidence and severity of cytokine release syndrome (CRS). Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the Teclistamab step-up dosing schedule.
  

• Teclistamab can cause CRS (cytokine release syndrome), including life-threatening or fatal reactions. One should administer pretreatment medications to reduce the risk of CRS and monitor patients following the administration of Teclistamab accordingly. At the first sign of CRS, immediately evaluate the patient for hospitalization. Withhold or permanently discontinue Teclistaman based on severity.
• Tecvayli can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Due to the potential for neurologic toxicity, patients receiving Tecvayli are at risk of depressed levels of consciousness. 
• Teclistamab is available only through a restricted program under a REMS called the Tecvayli REMS because of the risks of CRS and neurologic toxicity, including ICANS. The drug Teclistamab can cause hepatotoxicity, including fatalities. One should monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Healthcare professionals recommend withholding Tecvayli or considering permanent discontinuation of Tecvayli based on severity.
• Teclistamab can cause severe, life-threatening, or fatal infections. One should monitor patients for signs and symptoms of infection prior to and during treatment with Teclistamab and treat appropriately. Monitor patients for signs and symptoms of infection prior to and during treatment with Teclistamab and treat appropriately.
• Based on its mechanism of action, Teclistamab may cause fetal harm when administered to a pregnant woman. Healthcare professionals advise pregnant women of the potential risk to the fetus. Reproductive potential females should use effective contraception during treatment with Teclistamab and for 5 months after the last dose. 

Adverse Reactions

The most common adverse reactions of Teclistamab are e pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.  

Drug Interactions

Tecvayli causes the release of cytokines that may suppress the activity of cytochrome P450 (CYP) enzymes, resulting in increased exposure of CYP substrates. The highest risk of drug-drug interaction is expected to occur from initiation of the Teclistamab step-up dosing schedule up to 7 days after the first treatment dose and during and after CRS. 

Documentation & Availability

What documents are required to import Tecvayli to India? 

Patients or government hospitals can import Tecvayli (Teclistamab) tablets on behalf of patients. The following documentation is required to import the product:

• A valid prescription from a qualified doctor.
• Patient’s diagnostic reports.
• Patient’s ID proof (issued by the Government of India).

How is the order confirmed? 

The order will be confirmed only after the receipt of:

• A valid prescription from a doctor.
• Import permit if applicable.

Is Teclistamab available in India?

Tecvayli (Teclistamab) tablets are a prescription pharmaceutical drug that legally requires a medical prescription for dispensation.

Indian Pharma Network (IPN) facilitates the import of critical medications like Teclistamb into India, ensuring the named patient supply (NPS). IPN is the facilitator that provides essential support for:

• Availability of Teclistamab in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Pune, and more).
  
• Determining Medicine Price.
  
• Sourcing genuine and reliable sources from the USA, Canada, Europe, and Australia.
  
• Ensuring 100% transparency.

Indian Pharma Network (IPN) can facilitate the supply of Teclistamab (prescription medicine) to locations worldwide and in India while adhering to legal requirements (if applicable).

What class of drug is Tecvayli?

Tecvayli (Teclistamab) belongs to the class of monoclonal antibodies. 

Is Teclistamab FDA approved?

The FDA approved Teclistamab in 2022 for the treatment of relapsed or refractory multiple myeloma.

What is the Tecvayli mechanism of action?

Teclistamab-cqyv is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro, teclistamab activated T-cells caused the release of various proinflammatory cytokines and resulted in the lysis of multiple myeloma cells.  

Is Tecvyali available in India?

Yes, it’s available with a valid doctor’s prescription and required documentation.