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Tecvayli

Pronunciation: tek-vay-lee
Generic name: teclistamab-cqyv
Dosage form: subcutaneous injection
Drug class: Miscellaneous antineoplastics

Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 22, 2024.

What is Tecvayli?

Tecvayli (teclistamab) is an FDA-approved medicine for multiple myeloma (a cancer of the bone marrow) that is used by adults who have not responded to at least 4 prior treatments, or who have relapsed despite prior treatments. Tecvayli helps the immune system fight cancer cells by binding to them, allowing the immune system to recognize and attack the cancer cells. 

Tecvayli is available under a special program called Risk Evaluation and Mitigation Strategy (REMS).

Who can use Tecvayli?

Tecvayli is used in patients who have already received at least 4 treatment regimens for their multiple myeloma, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. It is used when the cancer has come back or did not respond to prior treatment.

How does Tecvayli work?

In multiple myeloma, there is a high number of certain antigens present on the cancer cells called BCMA (short for B-cell maturation antigen). Tecvayli is a monoclonal antibody that specifically targets and binds to these BCMA antigens on the cancer cells. It also binds to a protein on the surface of T cells (cells in the immune system) called CD3.  By doing so, Tecvayli helps activate the immune system to kill the cancer cells.

Warnings

Tecvayli may cause side effects that are serious, life-threatening, or lead to death, including: 

Call your healthcare provider right away if you develop any of the signs or symptoms of CRS or neurologic problems listed below at any time during your treatment:

Due to the risk of CRS and neurologic symptoms, you will need to stay in the hospital for 48 hours after all doses of Tecvayli that are part of the “step-up dosing schedule.” For more information about the “Step-up dosing schedule” see How will I receive Tecvayli? section below.

Before taking this medicine

To make sure Tecvayli is safe for you, tell your doctor if you have:

Pregnancy

Breastfeeding

How will I receive Tecvayli?

Follow all the directions on your instruction sheets.  Read the Patient Wallet Card about serious side effects and learn what symptoms to watch for. Keep the card with you at all times.

Tecvayli is given by a healthcare provider as an injection under the skin (subcutaneous injection) in the stomach-area, thigh, or another area.

Tecvayli is given initially as Step-up doses.

The next dose is the first treatment dose which is higher than step-up dose 1 and step-up dose 2. The first treatment dose is usually on day 7 and is usually weekly after that.

You will need to stay in the hospital for 48 hours after Step-up dose 1, Step-up dose 2, and your first treatment dose. Talk with your doctor if you have any questions.

You may be given other medications to help prevent serious side effects. Keep taking these medicines for as long as your doctor has prescribed.

Your treatment with this medicine may be temporarily or completely discontinued if you have certain side effects.

You will need medical tests before and during treatment with Tecvayli.

Tecvayli maintenance dosage

Patients who have achieved and maintained a complete response or better for a minimum of 6 months may be transferred to biweekly dosing. 

Tecvayli Dosing information

Tecvayli is available as:

Usual Adult Dose for Multiple Myeloma

Dosing Schedule

Day

Dose

Step-up Dosing Schedule

Day 1

Step-up dose 1

0.06 mg/kg

Day 4

Step-up dose 2

0.3 mg/kg

Day 7

First treatment dose

1.5 mg/kg

Weekly Dosing Schedule

One week after the first treatment dose and weekly thereafter

Subsequent treatment doses

1.5 mg/kg once weekly

Patients who have achieved and maintained a complete response or better for a minimum of 6 months

Biweekly (every 2 weeks) dosing schedule

The dosing frequency may be decreased to 1.5 mg/kg every 2 weeks

Comments:

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Tecvayli?

Avoid driving or hazardous activity for 48 hours after receiving certain doses of this medicine or until neurological symptoms go away. Your reactions could be impaired.

Tecvayli side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effects: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Tecvayli may cause serious side effects. Call your doctor at once if you have:

Common Tecvayli side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What other drugs will affect Tecvayli?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. To check for interactions with Tecvayli click on the link below.

Storage

What are the ingredients of Tecvayli?

Active ingredient: teclistamab-cqyv

Inactive ingredients: edetate disodium, glacial acetic acid, polysorbate 20, sodium acetate, sucrose, Water for Injection

Manufacturer:

Janssen Biotech, Inc., Horsham, PA 19044

Further information

Popular FAQ

Yes, Tecavyli (generic name: teclistamab-cqyv) received accelerated approval by the FDA in October 2022 to treat adults with multiple myeloma (cancer of cells in bone marrow) that has come back or failed previous treatment. Patients eligible for Tecvayli have a high unmet need for treatment, as they have received at least 4 prior lines of cancer therapy. Continue reading

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

Both Tecvayli and Talvey are bispecific CD3 T-cell engager antibody drugs used to treat multiple myeloma, but they target different proteins on the myeloma cancer cell to cause its death. Tecvayli targets B cell maturation antigen (BCMA) and Talvey targets G protein-coupled receptor, class C group 5 member D (GPRC5D). Continue reading

The active substance in Tecvayli, teclistamab-cqyv, is an antibody that works by activating T-cells (a type of white blood cell) in the immune system to help find and kill multiple myeloma cancer cells in your body. Tecavyli helps to bring together the cancer cell and the T-cell for anti-cancer action. Continue reading

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.