Prescription medicine
Teclistamab Brand names: Tecvayli
Teclistamab (Tecvayli) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the teclistamab FDA label on DailyMed (effective March 10, 2026); every teclistamab label on DailyMed.
Highlights of the record
FDA label of March 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
CYTOKINE RELEASE.
SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.5) and Warnings and Precautions (5.1) ]. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ]. Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS [see Warnings and Precautions (5.3) ]. WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageTECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Forms and strengths
- 10 mg/ml
- 90 mg/ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,119 through July 30, 2026
What is teclistamab used for?
From the label: indications and usageTECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. […]
Conditions named in the indications of teclistamab's FDA labels, with every medicine labeled for each:
Source: FDA drug label (TECVAYLI), Janssen Biotech, Inc., effective March 10, 2026 (SPL set 54e0f974-ccee-44ea-9254-40e9883cee1e), via openFDA; the full label on DailyMed
What does the patient leaflet for teclistamab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TECVAYLI?TECVAYLI can cause side effects that are serious, life-threatening or cause death, including cytokine release syndrome (CRS) and neurologic problems. Cytokine Release Syndrome (CRS). Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including: 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. See " What are the possible side effects of TECVAYLI? " for information about the signs and symptoms of liver problems. Due to the risk of CRS, you will receive TECVAYLI on a "step-up dosing" schedule. You should be hospitalized for 48 hours after the first and second step-up doses and should stay close to a healthcare facility and be monitored by a healthcare provider for 48 hours after you receive your first treatment dose. During the step-up dosing schedule your TECVAYLI dose will be increased for the first 3 doses. You will receive: a smaller step-up dose as your first dose on day 1 of treatment an increased step-up dose as your second dose, usually around day 3 or 4 of treatment an increased dose as your first treatment dose, usually around day 7 of treatment Your healthcare provider will decide the number of days to wait between your doses of TECVAYLI and how many treatments you will receive. If your dose of TECVAYLI is delayed for any reason, you may need to repeat the step-up dosing schedule. 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 with future doses. Neurologic problems. […]
From the patient leaflet: What should I avoid while receiving TECVAYLI?Do not drive or operate heavy or dangerous machinery during and for 48 hours after your TECVAYLI step-up dosing schedule is completed, or at any time during treatment with TECVAYLI if you develop new neurologic symptoms such as dizziness, confusion, tremors, sleepiness, or any other symptoms that impair your consciousness, until the symptoms go away. See " What is the most important information I should know about TECVAYLI? " for more information about signs and symptoms of neurologic problems.
Source: FDA drug label (TECVAYLI), Janssen Biotech, Inc., effective March 10, 2026 (SPL set 54e0f974-ccee-44ea-9254-40e9883cee1e), via openFDA; the full label on DailyMed
Is there a generic for teclistamab (Tecvayli)?
No generic teclistamab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the teclistamab label say about other medicines?
The teclistamab label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name teclistamab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Daratumumab | warnings and precautions | In MajesTEC-3, ICANS was reported in 1.1% of patients who received the recommended TECVAYLI dosage in combination with daratumumab and hyaluronidase-fihj, including Grade 4 ICANS in 1 patient. |
| Talquetamab | boxed warning | Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS [see Warnings and Precautions (5.3) ]. |
Source: FDA drug label (TECVAYLI), Janssen Biotech, Inc., effective March 10, 2026 (SPL set 54e0f974-ccee-44ea-9254-40e9883cee1e), via openFDA; the full label on DailyMed
What do FAERS reports show for teclistamab?
The FDA Adverse Event Reporting System holds 2,119 reports that list teclistamab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 421 are coded as a death and 519 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as teclistamab?
7 other medicines are given the same way (subcutaneous) and in the same FDA class as teclistamab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Elranatamab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Epcoritamab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Hyaluronidase and rituximab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Mosunetuzumab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Talquetamab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Daratumumab and hyaluronidase | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Isatuximab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Teclistamab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other