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Teclistamab

Generic name: teclistamab-cqyv
Brand name: Tecvayli
Dosage form: subcutaneous injection 30 mg/3 mL (10 mg/mL) , 153 mg/1.7 mL (90 mg/mL)
Drug class: Bispecific T-cell engagers (BiTE)

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 26, 2024.

What is teclistamab?

Teclistamab (Tecvayli) is a treatment for relapsed or refractory multiple myeloma used to help slow disease progression, manage symptoms, and improve quality of life. Teclistamab works by binding to both the cancer cells and T-cells from the immune system, which causes cancer cells to die. Teclistamab multiple myeloma treatment is given as an infusion weekly or two weekly as a maintenance dose. Teclistamab brand name is Tecvayli.

Teclistamab FDA approval indication is for relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. FDA approval is an accelerated approval based on the response rate in clinical trials, and continued approval may be dependent on further results in the confirmatory trial(s).

Multiple myeloma is a blood cancer of a type of white blood cell called plasma cells, which are found in the bone marrow. In multiple myeloma, these plasma cells change, spread rapidly, and replace normal cells in the bone marrow with tumors. On the outside of multiple myeloma cancer cells, there is a large number of proteins called BCMA (short for B-cell maturation antigen). Teclistamab-cqyv can target the MM cancer cells by binding to BCMA proteins.

How does Teclistamab work?

Teclistamab mechanism of action (MOA) is by binding to the BMCA antigen on the cancer cell and the CD3 receptor on the T-cell; this activates the immune system and causes the MM cells to die. 

The teclistamab class of medicines is bispecific T-cell engager antibodies, and it has two parts: one section binds to proteins called BMCA on the outside of the multiple myeloma cells, and the other section binds to T-cells from the immune system.

Teclistamab REMS

Teclistamab is available under a special program called Risk Evaluation and Mitigation Strategy (REMS). Teclistamab REMS goal is to prevent, monitor, and manage the serious risk of cytokine release syndrome (CRS)  and neurologic toxicity. This helps to ensure the benefits of teclistamab-cqyvi outweigh its risks. 

See “What should I know about the Tecvayli (Teclistamab) REMS program?” for more information.

Teclistamab side effects

Common teclistamab side effects

Common teclistamab side effects may include:

Serious ​​teclistamab side effects

Get emergency medical help if you have signs of an allergic reaction, including hives, difficulty breathing, or 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.

Teclistamab-cqyv may cause other serious side effects. Call your doctor at once if you have:

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Warnings

Teclistamab-cqyv 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:

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”.

Before taking this medicine

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

Pregnancy

Breastfeeding

How will I receive teclistamab?

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.

Teclistamab administration

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

Teclistamab 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 this medicine.

Teclistamab maintenance dosage

Patients who have achieved and maintained a complete response or better for a minimum of 6 months may be transferred to every two weeks (biweekly )dosing schedule.

Teclistamab Dosing information

Usual Adult Dose of Teclistamab 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

General dosing information

Teclistamab (Tecvayli) is available as:

Carvykti, Abecma, Darzalex, Revlimid, Velcade, Pomalyst, Kyprolis, Ninlaro

Teclistamab J code

Teclistamab J-code is J9380 (Tecvayli teclistamab-cqyv, 0.5 mg)
J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies. J codes are important accurate and consistent coding for billing and reimbursement purposes.

Your physician will need Tecvayli J-code when filling out forms for your treatment.

ICD-10-CM Diagnosis Codes

Diagnosis codes are used on both inpatient and outpatient claims.
ICD-10-CM Diagnosis Codes used for multiple myeloma include:

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 teclistamab?

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.

What other drugs will affect teclistamab?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. See the link below to check for interactions with this medicine.

Does teclistamab interact with my other drugs?

Enter other medications to view a detailed interaction report.

Teclistamab Package Insert 

Review the Teclistamab Package Insert (Tecvayli Package Insert) for more detailed information about this medicine. The Teclistamab Prescribing Information (PI) contains more detailed information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you may have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Storage

Ingredients

Active ingredient: teclistamab-cqyv

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

Manufacturer

Teclistamab manufacturer Janssen Biotech, Inc., Horsham, PA 19044, USA (Tacvayli Brand)

teclistamab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for teclistamab.

Tecvayli (teclistamab-cqyv) - Janssen Biotech, Inc.
Formulation type Strength
Single-Dose Vial 153 mg/1.7 mL (90 mg/mL)
Single-Dose Vial 30 mg/3 mL (10 mg/mL)

View Tecvayli information in detail.

Popular FAQ

What is the mechanism of action for Tecvayli (teclistamab-cqyv)?

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.