Prescription medicine

Hyaluronidase and nivolumab Brand names: Opdivo

Hyaluronidase and nivolumab (Opdivo) is a prescription medicine. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the hyaluronidase and nivolumab FDA label on DailyMed (effective May 12, 2026); every hyaluronidase and nivolumab label on DailyMed.

Highlights of the record

FDA label of May 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
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.

Forms and strengths

120 mg/ml

Injection (solution).

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: 89 through July 30, 2026

What is hyaluronidase and nivolumab used for?

From the label: indications and usage
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. (1.1)
Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma.
adult patients with advanced RCC, as a first-line treatment in combination with cabozantinib. (1.1)
adult patients with advanced RCC who have received prior anti-angiogenic therapy. […]

Conditions named in the indications of hyaluronidase and nivolumab's FDA labels, with every medicine labeled for each:

Lung cancer

From other hyaluronidase and nivolumab labels
Lung cancer: adult patients with metastatic NSCLC and progression on or after platinum-based chemotherapy.

FDA pharmacologic class: Endoglycosidase and Programmed Death Receptor-1 Blocking Antibody.

Source: FDA drug label (OPDIVO QVANTIG), E.R. Squibb & Sons, L.L.C., effective May 12, 2026 (SPL set 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b), via openFDA; the full label on DailyMed

What does the patient leaflet for hyaluronidase and nivolumab 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 OPDIVO QVANTIG?
OPDIVO QVANTIG is a medicine that may treat certain cancers by working with your immune system. OPDIVO QVANTIG can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Some of these problems may happen more often when OPDIVO QVANTIG is used in combination with another therapy. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems. • cough • shortness of breath • chest pain Intestinal problems. • diarrhea (loose stools) or more frequent bowel movements than usual • stools that are black, tarry, sticky, or have blood or mucus • severe stomach-area (abdominal) pain or tenderness Liver problems. […] These are not all of the signs and symptoms of immune system problems that can happen with OPDIVO QVANTIG. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: • chest pain, irregular heartbeat, shortness of breath or swelling of ankles • confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs • double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight • persistent or severe muscle pain or weakness, muscle cramps • low red blood cells, bruising Rejection of a transplanted organ or tissue. […]

Source: FDA drug label (OPDIVO QVANTIG), E.R. Squibb & Sons, L.L.C., effective May 12, 2026 (SPL set 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b), via openFDA; the full label on DailyMed

Is there a generic for hyaluronidase and nivolumab (Opdivo)?

No generic hyaluronidase and nivolumab 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 hyaluronidase and nivolumab label say about other medicines?

The hyaluronidase and nivolumab label names 3 other medicines in its interaction, contraindication or warning sections. 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
Cabozantinib	warnings and precautions	Intravenous Nivolumab with Cabozantinib Nivolumab in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to nivolumab alone.
Dexamethasone	warnings and precautions	Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
Prednisone	warnings and precautions	In general, if OPDIVO QVANTIG requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less.

Check hyaluronidase and nivolumab against other medicines

Source: FDA drug label (OPDIVO QVANTIG), E.R. Squibb & Sons, L.L.C., effective May 12, 2026 (SPL set 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b), via openFDA; the full label on DailyMed

What do FAERS reports show for hyaluronidase and nivolumab?

The FDA Adverse Event Reporting System holds 89 reports that list hyaluronidase and nivolumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 4 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.

The most reported reactions

Off Label Use (a use or a product term, not a reaction)17
Product Storage Error11
Rash (named in the label)9
Arthralgia (named in the label)6
Fatigue (named in the label)5
Death (an outcome recorded in the report)4
Diarrhoea (named in the label)4
Product Dose Omission Issue (a use or a product term, not a reaction)4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as hyaluronidase and nivolumab?

1 other medicine is given the same way (subcutaneous) and in the same FDA class as hyaluronidase and nivolumab or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 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
Berahyaluronidase alfa and pembrolizumab	Lung cancer	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?

Other endoglycosidases: the pharmacologic class, with prices and generics
Hyaluronidase and nivolumab side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other