FDA Approves Tecvayli (Teclistamab cqyv) To Treat Relapsed or Refractory Multiple Myeloma In Adults After Four Previous Treatments. 

Introduction

Tecvayli (teclistamab cqyv) was approved by the FDA in December 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma. The drug is manufactured by Janssen Biotech, Inc. specializing in the development of innovative therapies for cancer treatment.

This blog will provide a comprehensive overview of Tecvayli, including its FDA approval, manufacturer details, indication, mechanism, dosage information, drug interactions, usage in specific populations, side effects, and other important information.

Indication

Tecvayli (Teclistamab) is a medication that engages both B-cell maturation antigen (BCMA) and CD3 T-cells. It is approved for adults facing relapsed or refractory multiple myeloma after undergoing at least four prior lines of treatment. This includes therapies involving a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Multiple Myeloma

Multiple myeloma, also recognized as Kahler’s disease, is a type of blood cancer originating from plasma cells. Plasma cells, responsible for producing antibodies to combat infections, become cancerous and accumulate in the bone marrow, disrupting normal blood cell production. Instead of generating functional antibodies, these cancer cells produce defective proteins, leading to complications associated with multiple myeloma. Treatment approaches vary, depending on factors such as the growth rate of the cancer and the presence of symptoms.

Symptoms Of Multiple Myeloma

In the early stages of multiple myeloma, symptoms may not manifest. However, when they do, they can encompass:

• Bone pain, particularly in the spine, chest, or hips
• Nausea
• Constipation
• Loss of appetite
• Mental fogginess or confusion
• Fatigue
• Infections
• Weight loss
• Weakness
• Thirst
• Frequent urination

Mechanism Of Tecvayli

Tecvayli works by binding to both multiple myeloma cells and T-cells, helping the immune system recognize and destroy the multiple myeloma cells. The drug is a bispecific antibody that targets both CD38 and GPRC56, which are found on multiple myeloma cells and T-cells, respectively. By binding to these targets, Tecvayli activates T-cells and promotes the destruction of multiple myeloma cells.

Dosage Information

The recommended dosing schedule for Tecvayli injection is 1.5 mg/kg once weekly. The drug is administered as a subcutaneous injection under the skin, usually in the abdomen, thigh, or another area of the body.

Tecvayli is offered in two distinct dosage forms: a 30 mg/3 mL (10 mg/mL) solution in a single-dose vial and a 153 mg/1.7 mL (90 mg/mL) solution in another single-dose vial. These formulations provide healthcare professionals with options to administer the appropriate dosage based on patient needs. 

Drug Interactions

Tecvayli may cause the release of cytokines, which could suppress the activity of CYP enzymes and result in increased exposure of CYP substrates. Healthcare providers should monitor for increased concentrations or toxicities of sensitive CYP substrates and adjust the dose of CYP substrate drugs as needed.

Warning And Precaution 

• Tecvayli comes with crucial warnings and precautions. Hepatotoxicity, potentially fatal, requires vigilant monitoring of liver enzymes and bilirubin. 
• There’s a risk of severe, life-threatening infections, demanding close observation and potential Tecvayli withholding in active infections. Regular monitoring for neutropenia is recommended.
• Systemic and local hypersensitivity reactions may occur, necessitating careful assessment and possible drug discontinuation. 

Usage in Specific Populations

Pregnancy: Based on its mechanism of action, Tecvayli may pose a risk of fetal harm if administered to pregnant women. No data from pregnant women or reproductive/developmental studies in animals are available. The potential risk to the fetus should be communicated, and the assessment of immunoglobulin levels in newborns from Tecvayli-treated mothers is advised.

Lactation: Data on teclistamab-cqyv’s presence in human milk and its effects on the breastfed child or milk production are unavailable. Due to potential serious adverse reactions, breastfeeding is not recommended during Tecvayli treatment and for 5 months after the final dose.

Fertility: Tecvayli may cause fetal harm in pregnant women. Pregnancy status verification is essential before initiating treatment. Females of reproductive potential should use effective contraception during Tecvayli treatment and for 5 months post-treatment.

Pediatric Use: The safety and efficacy of Tecvayli have not been established in pediatric patients.

Geriatric Use: No notable differences in safety or effectiveness were observed between patients aged 65-74 and younger patients. However, data for those 75 or older are insufficient to assess differences in safety or effectiveness.

Side Effects

Common side effects of Tecvayli include cytokine release syndrome, which can cause symptoms such as fever, chills, and body aches. Severe side effects are rare but may include events such as infections, gastrointestinal perforations, and allergic reactions. Healthcare providers should monitor patients for these side effects and provide appropriate supportive care.

How To Buy Tecvayli Online? 

For individuals seeking access to Tecvayli and navigating the intricate process of importation amidst complex regulations, Sansfro Health, a dedicated pharmaceutical procurement company, is poised to offer assistance. With a commitment to transparency in pricing, Sansfro Health is prepared to guide you through the importation journey. For inquiries regarding the Tecvayli price in India and a comprehensive understanding of the importation process, feel free to contact our dedicated Patient Support Team at (+91) 9315705373 or via email at help@sansfro.com. Sansfro Health strives to streamline the medication importation process, providing accurate pricing details for your convenience.

Conclusion 

In summary, Tecvayli emerges as a promising therapeutic option for adults contending with relapsed or refractory multiple myeloma, especially following a history of at least four prior lines of treatment. While offering renewed hope, it is imperative to underscore the potential for serious side effects associated with Tecvayli. Consequently, the initiation and administration of Tecvayli should be conducted exclusively under the vigilant supervision of a qualified healthcare provider. Prior to commencing treatment, a comprehensive discussion with the healthcare provider is mandatory, encompassing the disclosure of all pre-existing medical conditions to ensure a thorough evaluation of potential risks and benefits. This collaborative approach between patients and healthcare professionals is essential for making informed decisions and optimizing the overall management of multiple myeloma with Tecvayli.

Reference:

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf  
2.  https://reference.medscape.com/drug/Tecvayli-teclistamab-4000281 
3.  https://www.Tecvayli.com 
4. https://www.ema.europa.eu/en/documents/product-information/Tecvayli-epar-product-information_en.pdf