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 June 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:

• Melanoma in adults and children 12 years and older
  • That is unresectable or has spread (metastatic), either alone or in combination with ipilimumab
  • Adjuvant treatment for completely resected Stage IIB-IV melanoma
• Non-small cell lung cancer (NSCLC) in adults
  • Neoadjuvant treatment for resectable tumors ≥4cm or node-positive (with platinum-doublet chemotherapy)
  • Metastatic NSCLC with PD-L1 ≥1%, no EGFR/ALK mutations (first-line with ipilimumab)
  • Metastatic/recurrent NSCLC, no EGFR/ALK mutations (first-line with ipilimumab + 2 cycles platinum-doublet chemotherapy)
  • Metastatic NSCLC with progression after platinum-based therapy
• Malignant pleural mesothelioma in adults
  • Unresectable disease (first-line with ipilimumab)
• Renal cell carcinoma (RCC) in adults
  • Intermediate/poor risk advanced RCC (first-line with ipilimumab)
  • Advanced RCC (first-line with cabozantinib)
  • Advanced RCC after prior anti-angiogenic therapy
• Classical Hodgkin Lymphoma in adults
  • Relapsed/progressed after autologous stem cell transplant and brentuximab vedotin
  • After ≥3 systemic therapy lines, including autologous stem cell transplant
• Squamous cell cancer of the head and neck in adults
  • Recurrent/metastatic disease with progression after platinum-based therapy
• Urothelial carcinoma in adults
  • Adjuvant treatment for high-risk recurrence after radical resection
  • Unresectable/metastatic disease (first-line with cisplatin and gemcitabine)
  • Locally advanced/metastatic with progression during/after platinum therapy or within 12 months of neoadjuvant/adjuvant platinum therapy
• Colorectal cancer in adults and children 12 years and older
  • Unresectable/metastatic MSI-H or dMMR colorectal cancer (with ipilimumab)
  • MSI-H or dMMR metastatic disease progressed after fluoropyrimidine, oxaliplatin, and irinotecan
• Hepatocellular carcinoma (HCC) in adults
  • Unresectable/metastatic HCC (first-line with ipilimumab)
  • Previously treated with sorafenib (with ipilimumab)
• Esophageal cancer in adults
  • Completely resected esophageal/gastroesophageal junction cancer with residual disease after neoadjuvant chemoradiotherapy
  • Unresectable advanced/metastatic esophageal squamous cell carcinoma, PD-L1 ≥1% (first-line with chemotherapy or ipilimumab)
  • Unresectable advanced/recurrent/metastatic esophageal squamous cell carcinoma after prior chemotherapy
• Gastric/gastroesophageal junction cancer and esophageal adenocarcinoma in adults
  • Advanced/metastatic disease with PD-L1 ≥1% (with fluoropyrimidine and platinum-containing chemotherapy).
  • This indication is under the accelerated approval designation, meaning continued approval may be contingent upon a clinical benefit in confirmatory trials.

Side effects

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

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;
• mouth sores, altered sense of taste;
• itching, rash, redness, or blisters on your hands or feet;
• hormonal problems;
• liver problems;
• numbness, tingling, or burning pain in your hands or feet;
• fever, body aches;
• feeling weak, tired, or short of breath;
• cold symptoms such as runny or stuffy nose, cough, sore throat;
• headache, dizziness, increased blood pressure; or
• weight loss.

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

• constipation
• cough
• decreased appetite
• decreased weight
• diarrhea
• dizziness
• feeling tired
• fever
• headache
• itching
• low thyroid hormone levels (hypothyroidism)
• nausea
• pain in muscles, bones, and joints
• rash
• shortness of breath
• stomach-area (abdominal) pain
• upper respiratory tract infection
• vomiting.

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:

• Lung problems
  • new or worsening cough
  • shortness of breath
  • chest pain.
• Intestinal problems
  • diarrhea (loose stools) or more bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness.
• Liver problems
  • yellowing of your skin or the whites of your eyes
  • dark urine (tea colored)
  • severe nausea or vomiting
  • bleeding or bruising more easily than normal
  • pain on the right side of your stomach area (abdomen).
• Hormone gland problems
  • headaches that will not go away or unusual headaches
  • urinating more often than usual
  • hair loss
  • eye sensitivity to light
  • eye problems
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • dizziness or fainting
  • changes in mood or behavior, such as decreased
  • sex drive, irritability, or forgetfulness
  • feeling more hungry or thirsty than usual.
• Kidney problems
  • decrease in your amount of urine
  • swelling in your ankles
  • blood in your urine
  • loss of appetite.
• Skin problems
  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in your mouth or in your nose, throat, or genital area
  • fever or flu-like symptoms
  • swollen lymph nodes.

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:

• chest pain, irregular heartbeat, shortness of breath, 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. 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.

Related/similar drugs

Before taking this medicine

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

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have liver disease
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area in the past and have received other medicines that are similar to nivolumab
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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.

• Nivolumab is usually given once every 2 to 4 weeks. Your other cancer medicines may be given on different schedules. Your doctor will determine how long to treat you with all medicines.
• The dosage of nivolumab depends on the cancer being treated and the patient's age (see the Opdivo (nivolumab) Prescribing Information for complete nivolumab dosing information).
• You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving nivolumab.
• Nivolumab can cause side effects in many different parts of your body. You may be given medication to prevent certain side effects, and your cancer treatments may be delayed if you need treatment for a side effect.

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.

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.

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Further information

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