Skip to main content

Nivolumab

Pronunciation: knee-VOL-you-mab
Generic name: nivolumab
Brand name: Opdivo
Dosage form: injection for intravenous infusion (40 mg/4 mL, 100 mg/10 mL, 120 mg/12 mL, 240 mg/24 mL)
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 15, 2025.

What is nivolumab?

Nivolumab (Opdivo) is used to treat melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal cancer, and gastric/gastroesophageal junction cancer with esophageal adenocarcinoma. It is given as an intravenous infusion (infusion into your vein; IV) over 30 minutes, every 2 to 4 weeks, depending on the cancer type. Nivolumab may be used alone or in combination with other medicines, such as ipilimumab (Yervoy) or chemotherapy. 

Nivolumab is an immune checkpoint inhibitor that works by interfering with the growth and spread of cancer cells. Cancer cells express PD-L1 proteins that bind to T-cell PD-1 receptors, creating an immune "off switch." Nivolumab blocks PD-1 receptors, preventing this binding and removing the brake on T cells to attack cancer.

Nivolumab was first approved by the FDA in 2014, under the brand Opdivo. There is no generic or biosimilar.

FDA approvals and uses

Nivolumab is FDA-approved for:

Side effects

The most common side effects of nivolumab when used alone are:

The most common side effects of nivolumab and ipilimumab (Yervoy) in combination are:

Serious side effects and 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.

Immune system problems. Nivolumab is a medicine that may treat certain cancers by working with your immune system. Nivolumab 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. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended and may be more common when nivolumab is used in combination with other treatments. Call or see your healthcare provider right away if you develop any new or worsening symptoms, including:

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with nivolumab. Call or see your healthcare provider right away for new or worsening symptoms, which may include:

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), may occur in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you undergo transplantation either before or after being treated with Nivolumab. Your healthcare provider will monitor you for these complications.

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.

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).

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with nivolumab. Your healthcare provider may treat you with corticosteroids or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with nivolumab if you have severe side effects.

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

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.

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.

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 (IV infusion) by a healthcare provider. This medicine must be given slowly over 30 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 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

Your healthcare provider will store Nivolumab refrigerated at 2°C to 8°C (36°F to 46°F) and protect it from light by storing it in the original package until the time of use.

Nivolumab should not be frozen or shaken.

Nivolumab 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.

Who makes nivolumab?

Nivolumab is only available under the brand name Opdivo, which is made by Bristol Myers Squibb (BMS), headquartered in New York City.

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

Pembrolizumab vs. nivolumab: How do they compare?

Pembrolizumab and nivolumab are both prescription medications used to treat various types of cancers, including solid tumors and blood cancers. They may be used alone or in combination with other medicines for cancers that are more advanced, have spread in the body, or are no longer responding to previous treatments. Continue reading

Opdivo vs Opdivo Qvantig: What is the Difference?

Opdivo and Opdivo Qvantig are both immunotherapy treatments containing nivolumab that help fight cancer by interfering with cancer cell growth and spread. However, they have several key differences in their administration method, approved uses, and patient eligibility. Continue reading

More FAQ

Further information

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