Quick answers
- What is Nivolumab and hyaluronidase-nvhy used for?
- The FDA-approved label (Opdivo Qvantig, E.R. Squibb & Sons, L.L.C., May 12, 2026) says: “OPDIVO QVANTIG is a combination of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of: Renal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab. • Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nivolumab and hyaluronidase-nvhy have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nivolumab and hyaluronidase-nvhy?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nivolumab and hyaluronidase-nvhy been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Nivolumab and hyaluronidase-nvhy?
- 1 company lists prescription products of Nivolumab and hyaluronidase-nvhy in the FDA NDC Directory, including E.R. Squibb & Sons, L.L.C..
What Nivolumab and hyaluronidase-nvhy is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OPDIVO QVANTIG is a combination of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of: Renal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab. • Limitations of Use …
— FDA label: Opdivo Qvantig, E.R. Squibb & Sons, L.L.C., effective May 12, 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.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Opdivo Qvantig |
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.
- E.R. Squibb & Sons, L.L.C.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 |
|---|---|---|---|
| BLA761381 OPDIVO QVANTIG | Bristol-Myers Squibb | December 27, 2024 | 5, latest May 12, 2026 2026: Labeling · 2025: Efficacy · 2025: Efficacy |
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) | 2700798, 2700805, 2728491, 2728492 |
|---|---|
| SPL set ID of the quoted label | 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761381 |
| Active ingredients (FDA) | HYALURONIDASE (HUMAN RECOMBINANT) / NIVOLUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Opdivo Qvantig, E.R. Squibb & Sons, L.L.C., effective May 12, 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 →