Tecvayli

Generic name: Teclistamab-cqyv
Dosage form: subcutaneous injection. 30 mg/3 mL (10 mg/mL), 153 mg/1.7 mL (90 mg/mL).
Drug class: Miscellaneous antineoplastics

Usage of 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. 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).

Tecvayli side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult 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 effect: 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:

bruising, swelling, warmth, redness, oozing, or bleeding where an injection was given;

low white blood cell counts: symptoms may include fever, mouth sores, skin sores, sore throat, cough;

neurological problems: symptoms may include headache, jerking muscle movements, rigid muscles, feeling restless, numbness and tingling, confusion, problems speaking, muscle spasms, tremors, double vision, changes in handwriting, problems walking, muscle weakness in body or face, hearing loss, burning, throbbing, or stabbing pain;

signs of infection: symptoms may include fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or

liver problems: symptoms may include loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Tecvayli side effects may include:

headache;

nausea, diarrhea;

tiredness, weakness;

joint pain, muscle pain in the back, chest, arms, and legs;

cold symptoms such as stuffy nose, sneezing, sore throat; or

fever, chills, cough with mucus, chest pain, feeling short of breath.

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 FDA at 1-800-FDA-1088.

Before taking Tecvayli

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

an infection.

Pregnancy

You may need to have a negative pregnancy test before starting this treatment.

May harm an unborn baby. Use effective birth control while using teclistamab and for at least 5 months after your last dose. Tell your doctor if you become pregnant.

Breastfeeding

Do not breastfeed while using this medicine, and for at least 5 months after your last dose.

Relate drugs

How to use Tecvayli

Tecvayli is available as:

30 mg/3 mL (10 mg/mL) single-dose vial

153 mg/1.7 mL (90 mg/mL) single-dose vial.

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).

Warnings

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

Cytokine Release Syndrome (CRS). Call your doctor if you have symptoms of a serious side effect, such as fever, chills, trouble breathing, vomiting, or severe tiredness.

Neurologic problems. Call your doctor if you have symptoms of neurological problems such as headache, jerking muscle movements, numbness and tingling, tremor, double vision, problems walking, hearing loss.

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 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.

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.

Disclaimer

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