Tecvayli

About Tecvayli 

• Tecvayli received approval from the US FDA administration on October 25, 2022.
• Tecvayli is an anti-BCMA antibody which belongs to the drug class known as miscellaneous antineoplastics. Tecvayli is a bispecific treatment targeting B-cell maturation antigen (BCMA) and CD3 T-cells. 
• This medicine is used in adults with relapsed or refractory multiple myeloma who have undergone a minimum of four prior treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
• Tecvayli aids the immune system in battling cancer cells by attaching to them, enabling the immune system to identify and combat the cancerous cells.
• Multiple myeloma is a cancer that originates in abnormal plasma cells (type of WBC)  in the bone marrow, leading to the overproduction of non-functional antibodies and impacting bone health, immune function, and blood cell production.
• Symptoms such as bone pain, fatigue, frequent infections, anemia, and weakened bones. 
• Early detection and appropriate medical intervention are crucial for managing and treating multiple myeloma effectively.
• Tecvayli is available only through a restricted program called the Tecvayli Risk Evaluation and Mitigation Strategy (REMS).

Strength

Injection: 30 mg/3 mL (10 mg/mL); 153 mg/1.7 mL (90 mg/mL) in a single-dose vial

Recommended Dosage

Administering subcutaneous injections is a medical procedure for trained healthcare professionals, involving strict aseptic techniques, continuous monitoring for adverse reactions, and proper disposal of used materials according to medical waste guidelines.

• The recommended dosing schedule for Tecvayli involves a step-up dosing schedule starting on Day 1 with a dose of 0.06 mg/kg, followed by a step-up dose on Day 4 at 0.3 mg/kg. On Day 7, the first treatment dose is administered at 1.5 mg/kg. 
• Subsequent treatment doses of 1.5 mg/kg are given once weekly, starting one week after the first treatment dose and continuing weekly thereafter. This dosing regimen aims to optimize the therapeutic effects of Tecvayli.
• Following each dose within the Tecvayli step-up dosing schedule, patients should be hospitalized for 48 hours. 
• During this period, it is essential to administer pretreatment medications as recommended to ensure patient safety and manage potential side effects. 
• This hospitalization and pretreatment regimen contribute to a comprehensive approach in optimizing the administration of Tecvayli and monitoring patient well-being.

Important

If you are currently taking any medications, please inform your doctor before starting the new medicine. Encourage patients to communicate all concurrent medications, encompassing prescription drugs, over-the-counter medications, vitamins, and herbal products, to their healthcare providers. 

Refrain from driving or operating heavy machinery for 48 hours after completing the Tecvayli “step-up dosing schedule” and throughout the entire treatment. If new neurological symptoms develop during Tecvayli treatment, avoid driving or operating machinery until the symptoms resolve.

Warnings & Precautions

• Patients receiving Tecvayli are at risk of experiencing Cytokine Release Syndrome (CRS), which can be life-threatening. 
• Initiate treatment with the Tecvayli step-up dosing schedule to reduce the risk of CRS. In the event of CRS, withhold Tecvayli until it resolves or permanently discontinue based on the severity of the reaction. 
• Additionally, neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), may occur and could lead to serious or life-threatening reactions. 
• Patients should be closely monitored for signs or symptoms of neurologic toxicity, including ICANS, during Tecvayli treatment. 
• Similar to CRS, withhold Tecvayli until neurologic toxicity resolves or permanently discontinue based on severity. It is crucial to promptly inform your physician if you experience any symptoms related to these conditions.
• ELAHERE may affect the liver, leading to serious issues. So it is recommended to  monitor liver enzymes and bilirubin regularly during treatment.
• Life-threatening infections may occur, so monitor for signs, treat appropriately, and withhold ELAHERE in cases of active infection during the step-up dosing schedule.
• Neutropenia is possible; monitor blood counts regularly. 
• Systemic and local injection site reactions can occur; consider withholding or permanent discontinuation based on severity. 
• Patients should promptly inform their physician of any related symptoms.

Common Tecvayli Side Effects:

• Pyrexia
• Cytokine release syndrome
• Musculoskeletal pain
• Injection site reaction
• Fatigue
• Upper respiratory tract infection
• Nausea
• Headache
• Pneumonia
• Diarrhea
• Decreased lymphocytes
• Decreased neutrophils
• Decreased white blood cells
• Decreased hemoglobin
• Decreased platelets

Use in Specific Population

• The use of Tecvayli may potentially harm a developing fetus, based on animal studies. Hence,  it is essential to inform your doctor if you are pregnant, planning pregnancy, or suspect pregnancy before starting treatment. 
• Tecvayli is associated with hypogammaglobulinemia, indicating a need to assess immunoglobulin levels in newborns of mothers treated with the drug. 
• Breastfeeding while on Tecvayli is not advised due to potential serious adverse reactions in the child; patients should refrain from breastfeeding during treatment and for 5 months after the last dose. 
• Females of reproductive age should utilize effective contraception during treatment and for 5 months post-Tecvayli. 
• Safety and efficacy remain unestablished in pediatric patients. 
• No significant differences in safety or effectiveness were observed in patients aged 65 to 74 compared to younger individuals. 

Storage and Handling

• Store Tecvayli at room temperature of 2°C to 8°C (36°F to 46°F).
• Protect Tecvayli from light and moisture.
• Do not freeze.
• Avoid storing Tecvayli in the place where it may be exposed to heat or humidity.
• Keep Tecvayli out of the reach of children and pets.