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Tecvayli

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

Medically reviewed by Melisa Puckey, BPharm. Last updated on Dec 19, 2022.

What is Tecvayli?

Tecvayli (teclistamab-cqyv) is a prescription cancer medicine used to treat adults with specific types of multiple myeloma (cancer of plasma cells in bone marrow).  Tecvayli is given as an injection under your skin, starting with a step-up dosing schedule over the first week, then dosing is usually weekly. 

Tecvayli first received FDA approval on October 25, 2022 and is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Tecvayli REMS.

How Tecvayli works is the active ingredient teclistamab, which is a protein, recognizes and binds to an antigen on the myeloma cancer cells and at the same time binds to T cells from the immune system. The T cells are then able to kill the myeloma cancer cells.

How Tecvayli (teclistamab-cqyv) works at a more technical level is that Tecvayli is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell, this means that it targets both BCMA (B-cell maturation antigen) and CD3, the T-cell receptor. BCMA is expressed at high levels on multiple myeloma cells. Tecvayli works by redirecting CD3-positive T-cells to BCMA-expressing myeloma cells to induce the killing of the cancer cells.

What is Tecvayli used to treat?

Tecvayli is indicated for adult patients who have multiple myeloma and their cancer has come back or it has not responded to earlier treatment. They need to have had at least four treatment regimens, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

What is the cost of Tecvayli?

The cost for Tecvayli subcutaneous solution (10 mg/mL) is around $1,873 for a supply of 3 milliliters, depending on the pharmacy you visit.

For current Tecvayli prices, coupons and information on patient assistance programs click on this link: Tecvayli Price Guide.

Important information

Tecvayli may cause side effects that are serious, life-threatening or lead to death, including Cytokine Release Syndrome (CRS) and Neurologic problems.

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:

Cytokine Release Syndrome (CRS). Signs and symptoms of CRS may include:

  • fever (100.4°F or higher)
  • difficulty breathing
  • chills
  • dizziness or lightheadedness
  • fast heartbeat
  • feeling anxious
  • confusion or restlessness
  • headache
  • increased liver enzymes in your blood

Neurologic problems. Symptoms of neurologic problems include:

  • headache
  • jerking movements
  • rigid muscles
  • feeling restless
  • numbness and tingling (feeling like "pins and needles")
  • confusion
  • trouble speaking
  • muscle spasms
  • tremor
  • double vision
  • changes in your handwriting
  • problems walking
  • muscle weakness in your body or face
  • hearing loss
  • burning, throbbing, or stabbing pain

Due to the risk of CRS and neurologic symptoms, you should be hospitalized for 48 hours after all doses of Tecvayli that are part of the “step-up dosing schedule.” The “step-up dosing schedule” is when you receive the first 2 doses, which are called “step-up” doses, and then you receive the first “treatment dose”. After “step-up” dose 1, the dose is increased. After “step-up” dose 2, the dose is increased again when you receive the first “treatment dose”.

  • “Step-up dose 1” is given on day 1 of treatment. “Step-up dose 2” is usually given on day 4 of treatment. The first “treatment dose” is usually given on day 7 of treatment.
  •  Your healthcare provider will decide when you will receive “step-up dose 2” and your first “treatment dose.”
    • “Step-up” dose 2 may be given between 2 to 4 days after “step-up” dose 1, or up to 7 days after “step-up” dose 1 if you have certain side effects.
    • Your first “treatment dose” may be given between 2 to 4 days after “step-up” dose 2, or up to 7 days after “step-up” dose 2 if you have certain side effects.
  • Your healthcare provider will decide the number of days to wait between your doses as well as how many treatments you will receive.
  • If your dose is delayed for any reason, you may need to repeat the “step-up dosing schedule” to receive Tecvayli.
  • Before each “step-up” dose and your first “treatment dose” of Tecvayli you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.
  • Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment, as well as other side effects and treat you as needed.
  • Do not drive or operate heavy or dangerous machinery during and for 48 hours after your “step-up dosing schedule” is completed, or at any time during treatment if you develop new neurologic symptoms until the symptoms go away.

Tecvayli is available only through the Tecvayli Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems.

You will receive a Tecvayli Patient Wallet Card from your healthcare provider. Carry the Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Patient Wallet Card lists signs and symptoms of CRS and neurologic problems.

Get medical help right away if you develop any of the signs and symptoms listed on the Patient Wallet Card. You may need to be treated in a hospital.

  • If you have any questions about Tecvayli, ask your healthcare provider.
  • Your healthcare provider may temporarily stop, or completely stop your treatment if you develop CRS, neurologic problems or any other side effects that are severe.

See Tecvayli side effects for more information about side effects.

Before you receive Tecvayli

Before you receive Tecvayli, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection
  • are pregnant or plan to become pregnant. Tecvayli may harm your unborn baby.
    • Your healthcare provider should do a pregnancy test before you start treatment.
    • You should use effective birth control (contraception) during treatment and for 5 months after your last dose.
    • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if Tecvayli passes into your breast milk.
    Do not breastfeed during treatment and for 5 months after your last dose.

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.

How will I receive Tecvayli?

  • Tecvayli will be given to you by your healthcare provider as an injection under your skin (subcutaneous injection), usually in your stomach-area (abdomen), your thigh or another area of your body may be injected.
  • See Important information for information about how you will receive Tecvayli.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. It is important for you to be monitored closely for side effects during treatment.

Dosing information

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 first treatment dose and weekly thereafter

Subsequent treatment doses

1.5 mg/kg once weekly


Comments:
- Patients should be hospitalized for 48 hours after administration of all doses within the step-up dosing schedule.
- Step-up dose 2 may be given between 2 to 4 days after step-up dose 1 and may be given up to 7 days after step-up dose 1 to allow for resolution of adverse reactions.
- First treatment dose may be given between 2 to 4 days after step-up dose 2 and may be given up to 7 days after step-up dose 2 to allow for resolution of adverse reactions.
- Administer pretreatment medications 1 to 3 hours before each dose of the step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose to reduce the risk of CRS: corticosteroid (oral or intravenous dexamethasone 16 mg), histamine-1 (H1) receptor antagonist (oral or intravenous diphenhydramine 50 mg or equivalent), and antipyretics (oral or intravenous acetaminophen 650 mg to 1,000 mg or equivalent). 

Use: 
- treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 

Tecvayli side effects

Tecvayli may cause serious side effects, including:

See Important information.

Liver problems. Tecvayli can cause liver problems that may lead to death. Increased bilirubin and liver enzymes in your blood are common with Tecvayli and can also sometimes be severe.
These increases in liver enzymes can happen with or without you also having CRS. Your healthcare provider will monitor you for these problems before you start and during treatment.
Tell your healthcare provider if you develop any symptoms of a liver problem including:

  • tiredness
  • loss of appetite
  • pain in your right upper stomach-area (abdomen)
  • dark urine
  • yellowing of your skin or white part of your eyes

Infections. Upper respiratory tract infections and pneumonia are common with Tecvayli.
Tecvayli can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.

  • Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment.
  • Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment.
  • Tell your healthcare provider right away if you get a fever, chills or any signs or symptoms of an infection.

Decreased white blood cell counts. Decreased white blood cell counts are common with Tecvayli and can also be severe. Fever sometimes also happens with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will check your blood cell counts before you start and during treatment, and treat you as needed.

Allergic reactions and injection site reactions. Tecvayli can cause allergic reactions that can affect your whole body (systemic), and also cause injection site reactions.

  • Some people taking Tecvayli can develop symptoms of an allergic reaction that can affect your whole body and may include fever or a swollen tongue. Get medical help right away if you develop symptoms of an allergic reaction during treatment.
  • Injection site reactions are common with Tecvayli and can include: redness, heat, swelling, bruising, bacterial skin infection (cellulitis), discomfort, blood collection under the skin at the injection site (hematoma), and rash. Tell your healthcare provider if you develop any severe injection site reactions.
    Your healthcare provider may temporarily or permanently stop Tecvayli if you have any of the side effects listed above and they are severe.

The most common side effects of Tecvayli include:

  • fever
  • pain in your joints and muscles, back and chest muscles, and in your arms and legs
  • tiredness and weakness
  • upper respiratory tract infections and pneumonia. See Infections above.
  • nausea
  • headache
  • diarrhea

The most common severe abnormal lab test results with Tecvayli include: decreased white blood cells, red blood cells and platelets.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General Information about Tecvayli.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

You can ask your healthcare provider for information that is written for health professionals.

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

Popular FAQ

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

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

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

Further information

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