Nivolumab
Pronunciation: nih-VOL-yoo-mab.
- Generic name
- nivolumab
- Drug class
- PD-1 immune checkpoint inhibitor (monoclonal antibody)
- Form
- IV infusion concentrate/solution
- Route
- Intravenous infusion (a newer subcutaneous form has also been approved in some countries)
- Legal status
- Prescription-only, specialist-initiated (oncology, given at an infusion centre)
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Opdivo (4) · Full directory
What nivolumab is and how it works
Nivolumab is a prescription-only cancer medicine (an immune checkpoint inhibitor) that helps the immune system recognise and attack cancer cells. It is approved for many different types of cancer. (1)
Nivolumab is given by infusion into a vein at a cancer treatment centre, on a schedule and combination of medicines set by your cancer specialist based on your specific cancer type. Because it works by adjusting your immune system, it can cause inflammation-related side effects in almost any part of the body, which your care team monitors for throughout treatment.
Mechanism of action: how nivolumab works
Nivolumab is a human IgG4 monoclonal antibody that blocks the PD-1 receptor on T cells, removing a brake on the immune system so T cells can better recognise and attack cancer cells. (1)
What nivolumab is used for
Treatment of multiple cancer types
Approved for use, alone or combined with other cancer medicines, in a wide range of cancers including melanoma (skin cancer), non-small cell lung cancer, mesothelioma, kidney cancer, classical Hodgkin lymphoma, head and neck cancer, bladder (urothelial) cancer, certain colorectal cancers, liver cancer (hepatocellular carcinoma), and oesophageal/stomach cancers. The exact use, dose, and combination depend on the specific cancer and stage being treated. (1)
Before taking nivolumab
Do not take / not appropriate for
- The US prescribing information for OPDIVO (nivolumab) lists no contraindications — section 4 of the label reads "None." There is no group of people for whom the label states outright that nivolumab must not be used. (all countries) (1)
- Because there are no contraindications, the decision to treat rests on the warnings and precautions instead — in particular the immune-mediated reactions that can affect the lungs, bowel, liver, kidneys, skin, and hormone glands. Discuss these with the oncology team before starting. (all countries) (1)
Tell your clinician about
- Any autoimmune condition (such as Crohn's disease, ulcerative colitis, lupus, or rheumatoid arthritis) -- nivolumab can worsen these.
- Any organ transplant, as nivolumab can increase the risk of organ rejection.
- Any lung, bowel, liver, kidney, thyroid, or hormone gland problems.
- Any previous infusion reaction to a similar cancer medicine.
- Pregnancy, plans for pregnancy, or breastfeeding.
- All other medicines you take, including other cancer treatments.
How to take nivolumab
- Nivolumab is given as an infusion into a vein over about 30 minutes, by a healthcare professional at a cancer treatment centre.
- Treatment continues on a set schedule until your cancer specialist decides to stop, either because the treatment is no longer working or because of side effects.
- Your dose is not reduced if side effects occur -- instead, your specialist may delay a dose or stop treatment altogether, depending on the type and severity of any reaction.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)
Missed dose
Nivolumab is scheduled and given by your treatment team -- if you are unable to attend a scheduled infusion, contact your care team as soon as possible to arrange rescheduling.
Overdose
Nivolumab is given under direct medical supervision at a treatment centre, where any dosing concerns are managed by the treating team at the time. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Tiredness (fatigue) and weakness.
What to notice: Tiredness (fatigue) and weakness.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Rash and itching.
What to notice: Rash and itching.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Muscle, joint, or back pain.
What to notice: Muscle, joint, or back pain.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Diarrhoea, nausea, vomiting, constipation, decreased appetite, and abdominal pain.
What to notice: Diarrhoea, nausea, vomiting, constipation, decreased appetite, and abdominal pain.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Cough, breathlessness, fever, and headache.
What to notice: Cough, breathlessness, fever, and headache.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Urinary tract and upper respiratory tract infections.
What to notice: Urinary tract and upper respiratory tract infections.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Signs of lung inflammation (pneumonitis) — emergency
Symptoms: New or worsening cough, chest pain, or shortness of breath.
Action: Tell your care team immediately. Your specialist may pause treatment and prescribe a corticosteroid, or permanently stop nivolumab depending on severity. (1)
Signs of bowel inflammation (colitis) — high caution
Symptoms: Diarrhoea, severe stomach pain, or blood/mucus in the stool.
Action: Contact your care team promptly -- this is managed similarly with corticosteroids and, if needed, pausing or stopping treatment. (1)
Signs of liver inflammation (hepatitis) — high caution
Symptoms: Yellowing of the skin or eyes, dark urine, unusual tiredness, or pain on the right side of the stomach.
Action: Your specialist monitors liver blood tests regularly and will manage this if it occurs. (1)
Signs of hormone gland problems (endocrinopathies) — high caution
Symptoms: Persistent headache, vision changes, extreme tiredness, unexplained weight change, mood changes, dizziness, or fainting -- these can reflect problems with the thyroid, adrenal glands, pituitary gland, or blood sugar control.
Action: Tell your care team about any of these new symptoms -- hormone levels are checked regularly, and replacement hormone treatment may be needed. (1)
Signs of kidney inflammation (nephritis) — high caution
Symptoms: Reduced urination, blood in the urine, or swelling in the legs or feet.
Action: Your specialist monitors kidney function with blood and urine tests and will manage this if it occurs. (1)
Severe skin reactions — emergency
Symptoms: Widespread rash, blistering, peeling skin, or sores in the mouth.
Action: Seek urgent medical attention -- rare but serious skin reactions have been reported. (1)
Signs of heart or nerve inflammation — emergency
Symptoms: Chest pain, irregular heartbeat, severe muscle weakness, numbness, or difficulty with movement or swallowing.
Action: Seek urgent medical attention -- these are less common but serious immune-related reactions. (1)
Signs of an infusion reaction — high caution
Symptoms: Fever, chills, flushing, itching, dizziness, or breathing difficulty during or shortly after the infusion.
Action: Tell the infusion team immediately -- mild/moderate reactions may mean the infusion is slowed or paused; severe reactions mean nivolumab is stopped. (1)
Interactions
- Tell your specialist about all other medicines you take, especially other cancer treatments, immune-suppressing medicines, and corticosteroids, as these can affect how nivolumab works or how side effects are managed. (1)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Nivolumab can cause harm to an unborn baby. Effective contraception is needed during treatment and for 5 months after the last dose. (1) (2) (3) (4) (5) (6)
Breastfeeding
Breastfeeding is not recommended during treatment. (1) (2) (3) (4) (5) (6)
Children
Approved for some indications (such as melanoma) in patients 12 years and older, alongside adult use; not established for younger children. (1) (2) (3) (4) (5) (6)
Elderly
No specific dose adjustment based on age alone is described in the source reviewed. (1) (2) (3) (4) (5) (6)
Hepatic_impairment
Not established in the source reviewed for this dossier. (1) (2) (3) (4) (5) (6)
Renal_impairment
Not established in the source reviewed for this dossier. (1) (2) (3) (4) (5) (6)
Source_ids
Monitoring
Before starting
- Baseline organ function tests (liver, kidney, thyroid/hormone panel)
- Screening for autoimmune disease history
- Screening for prior organ transplant
During treatment
- Regular blood tests to monitor liver, kidney, and hormone gland function.
- Ongoing monitoring for any new symptoms suggesting inflammation in the lungs, bowel, skin, nerves, or heart.
- Close observation during and after each infusion for reaction symptoms.
Storage
Nivolumab is stored and prepared by the treatment centre; patients do not typically store or handle it themselves.
Professional information
Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.
United States
Indication: Multiple approved cancer indications (monotherapy)
Dose summary: 240 mg IV every 2 weeks or 480 mg IV every 4 weeks, 30-minute infusion, until progression or unacceptable toxicity. No dose reduction recommended. Combination-regimen dosing is indication-specific. Immune-mediated adverse reactions managed with corticosteroids (1-2 mg/kg/day prednisone equivalent) and withholding/discontinuation per severity grade.
Renal context: Not established in the source reviewed for this dossier. (1)
Hepatic guidance
Not established in the source reviewed for this dossier.
Overdose note
Administered under direct medical supervision at every dose; no self-administered overdose scenario applies. (1)
Frequently asked questions
Is nivolumab (Opdivo) available in the US, UK, Europe, Canada, Australia, and New Zealand?
Yes. Opdivo is approved in all of these regions and more than 65 countries worldwide, though the exact approved cancer types and funding/access arrangements can differ by country. (1) (2) (3) (4) (5) (6)
Why does nivolumab cause so many different side effects?
Nivolumab works by releasing a natural brake on the immune system so it can attack cancer cells. The same immune activation can sometimes also cause the immune system to attack healthy tissue anywhere in the body, which is why side effects can involve the lungs, bowel, liver, hormone glands, skin, or other organs, and why your care team monitors broadly during treatment. (1)
How are immune-related side effects of nivolumab treated?
Most immune-related reactions are managed by pausing or stopping nivolumab and giving corticosteroids, usually until the reaction improves, then tapering the steroid gradually over at least a month. If steroids alone are not enough, additional immune-suppressing medicines may be added. Your oncology team decides whether to pause, adjust, or permanently stop treatment based on how severe the reaction is. (1)
What is the mechanism of action of nivolumab?
Nivolumab is a human IgG4 monoclonal antibody that blocks the PD-1 receptor on T cells, removing a brake on the immune system so T cells can better recognise and attack cancer cells. (1)
What is the generic name of Nivolumab?
The generic name is nivolumab. (1)
What class of drug is nivolumab?
Nivolumab is classed as: PD-1 immune checkpoint inhibitor (monoclonal antibody). (1)
References
- OPDIVO (nivolumab) injection -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Bristol-Myers Squibb Company · United States · accessed 2026-07-29 · source 1
- European Commission approval history for Opdivo (nivolumab)Bristol Myers Squibb corporate press releases · European Union · accessed 2026-07-29 · source 2
- OPDIVO -- Summary of Product Characteristics (10 mg/mL concentrate and 600 mg/5 mL solution for injection)electronic medicines compendium (emc), United Kingdom -- Bristol Myers Squibb Pharmaceuticals Limited · United Kingdom · accessed 2026-07-29 · source 3
- OPDIVO -- ARTG registrationTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 4
- Health Canada approvals for Opdivo (nivolumab)Health Canada / Bristol Myers Squibb Canada press releases · Canada · accessed 2026-07-29 · source 5
- Medsafe approval and Pharmac funding widening for nivolumab (Opdivo)Medsafe (New Zealand regulator) and Pharmac (funder) · New Zealand · accessed 2026-07-29 · source 6
Brand names by country
Single-ingredient nivolumab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- OPDIVO10 mg/mL · e.r. squibb & sons, l.l.c.
United Kingdom
- Opdivo (3)MHRA licensed emc smpc confirmed · 10 mg/mL, 600 mg/5 mL · Bristol Myers Squibb Pharmaceuticals Limited
Canada
- OPDIVO
Australia
- Opdivo (4)TGA ARTG registered 2016-01-11 · 40 mg, 100 mg, 240 mg · Bristol-Myers Squibb Australia Pty Ltd
New Zealand
- Opdivo (6)Medsafe approved 2016-04 Pharmac funding widened 2026-05 · not specified in fetched source · Bristol Myers Squibb New Zealand
View brands in additional countries.
European Union
Opdivo (2)