Where can I find the Tecvayli FDA package insert?

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.

Related questions

• What’s the difference between Tecvayli and Talvey?
• What is the mechanism of action for Tecvayli (teclistamab-cqyv)?
• Is Tecvayli FDA approved as a multiple myeloma treatment?

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.