Quick answers
- What is Teclistamab-cqyv used for?
- The FDA-approved label (Tecvayli, Janssen Biotech, Inc., March 10, 2026) says: “TECVAYLI 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Teclistamab-cqyv have a boxed warning?
- Yes. The FDA label for Tecvayli has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Teclistamab-cqyv?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Teclistamab-cqyv been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Teclistamab-cqyv?
- 1 company lists prescription products of Teclistamab-cqyv in the FDA NDC Directory, including Janssen Biotech, Inc..
What Teclistamab-cqyv is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TECVAYLI 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. …
— FDA label: Tecvayli, Janssen Biotech, Inc., effective March 10, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Tecvayli |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Janssen Biotech, Inc.2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761291 TECVAYLI | Janssen Biotech | October 25, 2022 | 11, latest May 6, 2026 2026: REMS · 2026: Efficacy · 2025: REMS |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2619432, 2619438, 2619441, 2619444 |
|---|---|
| SPL set ID of the quoted label | 54e0f974-ccee-44ea-9254-40e9883cee1e |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761291 |
| Active ingredients (FDA) | TECLISTAMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tecvayli, Janssen Biotech, Inc., effective March 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →