Question 1

What is Tecvayli?

Accepted Answer

Tecvayli is a type of immunotherapy known as a bispecific T-cell engager. It is designed to bind to two different targets at the same time: a specific protein found on the surface of cancer cells and a protein found on T-cells, which are part of the body's immune system.

By linking these two cells together, the medication helps the immune system identify and attack the cancer cells more effectively. This mechanism of action allows the body's own natural defenses to focus on eliminating the diseased cells.

Question 2

What is Tecvayli used for?

Accepted Answer

Tecvayli is used to treat multiple myeloma .

Question 3

How does Tecvayli work?

Accepted Answer

How Tecvayli Works

Tecvayli (teclistamab-cqyv) is a type of immunotherapy known as a bispecific T-cell engager. It is designed to recognize and bind to two different targets at the same time to help the immune system fight cancer.

The medication works through the following mechanism:

Targeting Cancer Cells: One part of the antibody attaches to a protein called B-cell maturation antigen (BCMA), which is found on the surface of multiple myeloma cells.

Engaging Immune Cells: Another part of the antibody attaches to a protein called CD3, which is found on the surface of T-cells. T-cells are a type of white blood cell responsible for attacking foreign or abnormal cells in the body.

By binding to both targets simultaneously, Tecvayli acts like a bridge that pulls the T-cells directly to the myeloma cells. This close proximity activates the T-cells, triggering them to release substances that destroy the cancer cells. This process helps the immune system identify and eliminate cancer cells that might otherwise evade the body's natural defenses.

Question 4

What are the active ingredients in Tecvayli?

Accepted Answer

The active ingredient in Tecvayli is teclistamab .

Question 5

What are the side effects of Tecvayli?

Accepted Answer

Common side effects of Tecvayli may include:

fever

fatigue

nausea

and others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Tecvayli?

Accepted Answer

Tecvayli belongs to the BCMA-directed CD3 bispecific antibody drug class.

Question 7

What is the dosage of Tecvayli and how do I take it?

Accepted Answer

Administration

Tecvayli is given as a subcutaneous injection, which means it is injected into the fat layer just under the skin. It is usually administered in the abdomen or the thigh. A healthcare provider will give these injections in a clinical setting.

Dosing Schedule

Treatment usually begins with a step-up dosing schedule. This involves receiving smaller doses over the first several days to help the body adjust to the medication. After completing the step-up phase, the medication is typically administered once a week.

Depending on how the patient responds to the treatment, a healthcare provider may eventually adjust the schedule so that the injections are given every two weeks.

Monitoring and Missed Doses

Because of the risk of certain side effects, patients are often required to stay at a healthcare facility for monitoring for a few days after receiving the initial step-up doses. If a scheduled dose is missed, patients should contact their healthcare provider right away to determine the best time for the next injection.

Question 8

Is Tecvayli safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There are no adequate studies on the use of Tecvayli in pregnant women. Based on how the drug works, it may cause harm to a developing fetus. Healthcare providers usually require a pregnancy test before starting this medication to confirm you are not pregnant.

Females who are able to become pregnant should use effective birth control during treatment and for 5 months after the last dose. If you become pregnant while receiving this medication, notify your healthcare provider right away.

Breastfeeding

It is unknown if Tecvayli passes into breast milk or if it could affect a nursing child. Because of the potential for serious side effects in a breastfed infant, breastfeeding is not recommended during treatment and for 5 months after the final dose.

Question 9

What forms and strengths does Tecvayli come in?

Accepted Answer

Tecvayli is supplied as a sterile, preservative-free solution in single-dose vials. It is intended for subcutaneous administration, which involves injecting the medication into the fatty tissue layer just beneath the skin.

Subcutaneous Injection: The medication is administered as an injection under the skin, usually in the abdomen or thigh.

This medication is administered only by a healthcare provider in a clinical setting because of the need for monitoring during and after the injection.

Question 10

What is the FDA approval status of Tecvayli?

Accepted Answer

FDA Approval Status

The U.S. Food and Drug Administration (FDA) granted accelerated approval to Tecvayli in October 2022. This approval was based on the drug's response rate and the duration of that response in clinical trials. Because it was approved under the accelerated pathway, continued approval for this use may depend on the results of ongoing trials that confirm its clinical benefit.

Approved Indications

Tecvayli is indicated for the treatment of adults with multiple myeloma that has returned (relapsed) or did not respond to treatment (refractory). Patients must have previously received at least four different types of therapy, including:

A proteasome inhibitor

An immunomodulatory agent

An anti-CD38 monoclonal antibody

Boxed Warning and Safety Programs

The FDA has issued a Boxed Warning for Tecvayli due to the risk of two serious conditions:

Cytokine Release Syndrome (CRS): A systemic inflammatory response that can be severe or life-threatening.

Neurologic Toxicity: This includes Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which can cause confusion, seizures, or other brain-related issues.

Because of these risks, Tecvayli is only available through a restricted program called the Tecvayli Risk Evaluation and Mitigation Strategy (REMS) . Healthcare providers and facilities must be certified in this program to prescribe or administer the medication.

Regulatory Designations

During its development, Tecvayli received several special regulatory designations from the FDA, including Orphan Drug designation and Breakthrough Therapy designation. These designations are intended to expedite the development and review of drugs for serious or rare conditions.

Question 11

What should I know about Tecvayli and cost?

Accepted Answer

Insurance and Coverage

The amount you pay for Tecvayli depends largely on your health insurance plan. Most private insurance companies, as well as Medicare and Medicaid, typically provide coverage for this medication, though they often require prior authorization from your doctor. Your specific out-of-pocket costs will be determined by your plan's deductible, copayments, or coinsurance.

Factors Affecting Price

Several factors can influence the total cost of treatment with Tecvayli:

Treatment Phase: The dosage and frequency of injections change during the initial step-up phase and subsequent maintenance phases, which can affect the monthly cost.

Administration Fees: Since Tecvayli is administered by a healthcare professional, you may incur additional costs for the clinic visit and the procedure to give the injection.

Location: Costs may vary depending on whether the medication is administered in a hospital, an outpatient clinic, or a specialized infusion center.

Financial Assistance

If you are concerned about the cost of Tecvayli, several resources may be available to help:

Manufacturer Programs: The pharmaceutical company that produces Tecvayli may offer copay cards for patients with commercial insurance or patient assistance programs for those who are uninsured or underinsured.

Support Foundations: Non-profit organizations sometimes provide grants or financial aid to help patients with multiple myeloma cover their treatment expenses.

It is best to consult with your healthcare provider's billing office or your insurance company to get a detailed estimate of your expected costs.

Tecvayli

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

📚References

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