Prescription medicine
Talquetamab Brand names: Talvey
Talquetamab (Talvey) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the talquetamab FDA label on DailyMed (effective October 8, 2025); every talquetamab label on DailyMed.
Highlights of the record
FDA label of October 8, 2025; 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 TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.5 ), Warnings and Precautions (5.1) ]. Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life threatening or fatal reactions, can occur with TALVEY. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment and treat promptly. Withhold or permanently discontinue TALVEY based on severity [see Dosage and Administration (2.5), Warnings and Precautions (5.2) ]. Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (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 usageTALVEY is indicated for the 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.
Forms and strengths
- 3 mg/1.5ml
- 40 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
- 2,046 through July 30, 2026
What is talquetamab used for?
From the label: indications and usageTALVEY is indicated for the 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 and durability of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). […]
Conditions named in the indications of talquetamab's FDA labels, with every medicine labeled for each:
Source: FDA drug label (TALVEY), Janssen Biotech, Inc., effective October 8, 2025 (SPL set 9001355e-003d-4d4e-b4ce-337e0fd14952), via openFDA; the full label on DailyMed
What does the patient leaflet for talquetamab 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 TALVEY?TALVEY 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 or get medical help right away if you develop any of the signs or symptoms of CRS or neurologic problems listed below at any time during your treatment with TALVEY : Cytokine Release Syndrome (CRS). CRS is common during treatment with TALVEY and can also be serious, life-threatening, or lead to death. Signs and symptoms of CRS may include: fever (100.4°F or higher) dizziness or lightheadedness chills difficulty breathing feeling anxious headache fast heartbeat Neurologic problems. Symptoms of neurologic problems with TALVEY may include: headache feeling confused being less alert or aware feeling disoriented trouble speaking or writing shaking (tremors) numbness and tingling (feeling like "pins and needles") problems with walking, or loss of balance or coordination feeling sleepy feeling very sleepy with low energy slow or difficulty thinking seizures muscle weakness memory loss burning, throbbing, or stabbing pain fast eye movements that you cannot control Due to the risk of CRS and neurologic problems, you should be hospitalized for 48 hours after all doses of TALVEY that are part of the "step-up dosing schedule". The "step-up dosing schedule" is when you receive the first 2 or 3 doses of TALVEY, which are smaller "step-up" doses, and also the first full "treatment dose" of TALVEY. TALVEY is given weekly or every 2 weeks. Your healthcare provider will decide the number of days to wait between your doses of TALVEY as well as how many treatments you will receive. […]
From the patient leaflet: What should I avoid while receiving TALVEY?Do not drive, operate heavy machinery, or do other dangerous activities during and for 48 hours after your TALVEY "step-up dose" is completed or at any time during treatment with TALVEY, if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms of neurologic problems until your symptoms go away. See " What is the most important information I should know about TALVEY ?" for more information about signs and symptoms of CRS and neurologic problems.
Source: FDA drug label (TALVEY), Janssen Biotech, Inc., effective October 8, 2025 (SPL set 9001355e-003d-4d4e-b4ce-337e0fd14952), via openFDA; the full label on DailyMed
Is there a generic for talquetamab (Talvey)?
No generic talquetamab 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 talquetamab label say about other medicines?
The talquetamab label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name talquetamab. 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 |
|---|---|---|
| Teclistamab | boxed warning | Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS) [see Warnings and Precautions (5.3) ]. |
Source: FDA drug label (TALVEY), Janssen Biotech, Inc., effective October 8, 2025 (SPL set 9001355e-003d-4d4e-b4ce-337e0fd14952), via openFDA; the full label on DailyMed
What do FAERS reports show for talquetamab?
The FDA Adverse Event Reporting System holds 2,046 reports that list talquetamab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 225 are coded as a death and 517 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 talquetamab?
7 other medicines are given the same way (subcutaneous) and in the same FDA class as talquetamab 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 |
| Teclistamab | 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?
- Talquetamab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other