Where can I find the Tecvayli FDA package insert?

Q: Where can I find the Tecvayli FDA package insert?

You can access the Tecvayli package insert from several places. You can find the Tecvayli FDA package insert on the Janssen website, on the Drugs@FDA website, or under the FDA Professional Drug Information section on Drugs.com.

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Dec 3, 2024.

Official Answer by Drugs.com

You can access the Tecvayli FDA package insert from several places, including on the Drugs@FDA website, under the FDA Professional Drug Information section on Drugs.com and on the Janssen Tecvayli website.

You can also access Tecvayli consumer drug information written in plain language and specifically for patients on the Drugs.com website. The FDA Tecvayli Medication Guide can be found here.

The Tecvayli (pronounced tek vay’ lee) package insert is developed by Janssen, the drug manufacturer, approved by the FDA, and includes information such as:

FDA-approved uses (indications)
when you should not use Tecvayli (contraindications)
warnings and precautions
side effects
drug interactions
doses, strength, dosage forms, instructions for use and storage
manufacturer's clinical studies
patient Medication Guide.

Package inserts and Medication Guides are updated frequently when new uses are approved, when there is new side effect or safety data, and for other important information pertaining to the use and safety of the drug.

What is Tecvayli used for?

Tecvayli (teclistamab-cqyv) is approved for the treatment of adults with advanced multiple myeloma (cancer of bone marrow cells) that has come back or failed previous treatment. It is for patients that have received at least 4 prior treatment lines of cancer therapy. It is given as a subcutaneous (under the skin) injection.

Tecvayli was approved in October 2022 and is classified as bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It is the first drug of this type in its class. It works by directing T-cells (a type of white blood cell) to the myeloma cancer cells to cause cell death.

References

Tecvayli monograph. Drugs.com. Accessed Dec. 13, 2022 at https://www.drugs.com/tecvayli.html

What is the success rate of Tecvayli?

In the Phase 1/2 MajesTEC-1 study, the success rate of Tecvayli showed an overall response rate (ORR) of 61.8% (95%CI: 52.1 to 70.9%) in 110 patients with advanced multiple myeloma who had received at least 3 prior lines of therapy. Continue reading

What should I know about the Tecvayli REMS program?

The Tecvayli REMS Program is a restricted program developed by the manufacturer of Tecvayli (teclistamab) and the US Food and Drug Administration (FDA) intended to educate healthcare professionals and patients on the risks of using Tecvayli, including cytokine release syndrome and neurologic toxicity. Continue reading

What are the best treatments for Multiple Myeloma?

Multiple myeloma is a cancer of plasma cells, which are white blood cells responsible for producing antibodies. While not yet curable, advancements in therapy have transformed it into a manageable condition with treatments that can achieve long-term disease control and improved quality of life. Initial treatment usually involves multi-drug combinations, such as bortezomib (a proteasome inhibitor), lenalidomide (an immunomodulatory drug), and dexamethasone (a steroid).

Where can I find the Tecvayli FDA package insert?

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What is Tecvayli used for?

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What is the success rate of Tecvayli?

What should I know about the Tecvayli REMS program?

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