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Nivolumab

Pronunciation: nye-VOL-ue-mab
Generic name: nivolumab
Brand name: Opdivo
Dosage form: intravenous solution (10 mg/mL)
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 30, 2024.

What is nivolumab?

Nivolumab is a cancer medicine that is given intravenously (into a vein) that works with your immune system to interfere with the growth and spread of cancer cells in the body.

Nivolumab is used alone or in combination with other medicines to treat adults with:

For some cancers, such as melanoma and colorectal cancer, nivolumab is also approved for children aged 12 years and older. See the prescribing information for a full list of indications and eligibility criteria.

Nivolumab is often given when the cancer has spread to other parts of the body (metastatic), cannot be surgically removed, or has come back after prior treatment.

Nivolumab is sometimes given only if laboratory testing shows specific genetic markers or DNA mutations associated with your cancer.

Nivolumab belongs to the class of medicines known as checkpoint inhibitors and works by blocking the PD-1 (programmed death receptor-1) pathway to help prevent cancer cells from hiding from the immune system, boosting the immune system's response against cancer.

Nivolumab was first FDA-approved on December 22, 2014, under the brand name Opdivo. It is currently only available as Opdivo, there are no biosimilars.

Warnings

Nivolumab can cause serious, sometimes life-threatening, side effects in many different parts of your body. Some side effects may need to be treated with other medicines, and your cancer treatments may be delayed.

Call your doctor at once if you have a cough, shortness of breath or other lung problems, vision changes, muscle pain or weakness, stomach pain, diarrhea, blood in your stools, little or no urinating, bruising or bleeding, dark urine (tea colored), yellowing of your skin or eyes, severe nausea or vomiting, frequent headaches, dizziness, confusion, increased thirst or urination, skin problems, numbness or tingling, feeling cold, changes in mood or behavior, decreased sex drive, increased sweating, sensitivity to light or other eye problems, skin problems, bruising, or weight gain or loss.

Problems can also happen in other organs and tissues. These are not all signs and symptoms of immune system problems that can happen with Nivolumab.

Nivolumab can cause severe infusion-related reactions. Tell your healthcare provider right away if you experience chest tightness, wheezing, shortness of breath, facial flushing, itching, hives, swelling, or any other allergic reaction.

Life-threatening and other serious complications can occur in people who have received an allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody, such as Nivolumab.

May cause harm to an unborn baby. Females who can get pregnant should use an adequate form of contraception while being treated with nivolumab.

Before taking this medicine

To make sure Nivolumab is safe for you, tell your doctor if you:

Pregnancy

Nivolumab may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while receiving nivolumab and for at least 5 months after your last dose. Tell your doctor right away if you become pregnant.

Breastfeeding

It is not known if nivolumab passes into your breast milk. Do not breastfeed while using this medicine, and for at least 5 months after your last dose.

How is nivolumab administered?

Nivolumab is given as an infusion into a vein by a healthcare provider. This medicine must be given slowly and can take 30 to 90 minutes.

What happens if I miss a dose?

Call your doctor for instructions if you miss a chemotherapy appointment.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving nivolumab?

Follow your doctor's instructions about restricting food, beverages, or activity.

What are the side effects of nivolumab?

Nivolumab can cause serious side effects, including:

Get emergency medical help if you have signs of an allergic reaction to nivolumab (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common nivolumab side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What other drugs will affect nivolumab?

Other drugs may interact with nivolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Should not be given to patients with multiple myeloma who also take thalidomide medication in combination with dexamethasone unless they are part of a controlled clinical trial.

Does nivolumab interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Storage

Keep refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light by storing in the original package until the time of use.

Do not freeze or shake.

Ingredients

Active ingredient: nivolumab

Inactive ingredients: mannitol, pentetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for Injection. May contain hydrochloric acid and/or sodium hydroxide.

Manufacturer

Bristol-Myers Squibb Company.

Nivolumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for nivolumab.

Opdivo (nivolumab) - Bristol-Myers Squibb Company
Formulation type Strength
Single-Dose Vial 100 mg/10 mL (10 mg/mL)
Single-Dose Vial 120 mg/12 mL (10 mg/mL)
Single-Dose Vial 240 mg/24 mL (10 mg/mL)
Single-Dose Vial 40 mg/4 mL (10 mg/mL)

View Opdivo information in detail.

Popular FAQ

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.