Key points
- Nivolumab (Opdivo) is an immunotherapy drug: it releases the brake (PD-1) the cancer has put on immune cells [1].
- It is used for many cancers, including melanoma, lung, kidney, bladder, oesophageal, stomach, liver and bowel cancer and Hodgkin lymphoma [1].
- It is often given with ipilimumab; this combination is stronger but causes more immune side effects [1].
- It is given as a 30-minute drip, usually every 2 or 4 weeks [1].
- Immune-related inflammation of the lungs, bowel, liver or glands can be severe and may appear even after treatment ends; report any new symptom early [1] (immunotherapy side effects).
- Women should avoid pregnancy during treatment and for 5 months after the last dose, and should not breastfeed [1].
What is this drug and how does it work?
For physicians
Nivolumab (brand name Opdivo) is an IgG4 monoclonal antibody that blocks the PD-1 receptor [1]. It belongs to the immune checkpoint inhibitors and, instead of attacking cancer cells directly, works by helping the body's immune system [1].
Binding of PD-L1 and PD-L2 to the PD-1 receptor on T cells inhibits their proliferation and cytokine production. Some tumours upregulate these ligands and so escape immune surveillance [1]. Nivolumab binds PD-1, blocks the binding of PD-L1 and PD-L2 and releases the inhibition of the antitumour immune response [1].
When nivolumab is given with ipilimumab (a CTLA-4 inhibitor), blocking both pathways at once enhances T-cell function more than either drug alone [1]. This immune activation is also the main reason for the drug's side effects, because the immune system may attack healthy tissues too [1].
Which cancers is it used for?
According to the FDA label, nivolumab is approved alone or with ipilimumab, chemotherapy or cabozantinib, both in advanced disease and before or after surgery in some cancers [1]. Approved uses may differ between countries, and not every patient with these cancers is a candidate for this drug.
Your doctor may prescribe this drug for:
- Melanoma [1, 2]
- Non-small cell lung cancer [1, 3]
- Malignant pleural mesothelioma [1]
- Kidney cancer (renal cell carcinoma) [1, 4, 5]
- Classical Hodgkin lymphoma [1, 6]
- Head and neck cancer (squamous cell carcinoma) [1, 7]
- Bladder and urinary tract (urothelial) cancer [1, 8]
- MSI-H or dMMR colorectal cancer [1, 9]
- Hepatocellular carcinoma [1, 10]
- Oesophageal cancer [1, 11]
- Stomach, gastro-oesophageal junction and oesophageal adenocarcinoma [1, 12]
Whether it suits you depends on the type and stage of your cancer and your test results. Details of each use are in the section for doctors.
For physicians
| Cancer | Conditions of use | Key evidence |
|---|---|---|
| Melanoma | Unresectable or metastatic melanoma, alone or with ipilimumab; adjuvant treatment after complete resection of stage IIB, IIC, III or IV melanoma; in adults and children aged 12 and over [1] | CheckMate 067 trial [2] |
| Non-small cell lung cancer | Resectable tumours (≥4 cm or node-positive): before surgery with platinum doublet chemotherapy, or before surgery with chemotherapy and then alone after surgery (without known EGFR mutations or ALK rearrangements); first-line metastatic with ipilimumab in PD-L1 ≥1% tumours, or with ipilimumab and 2 cycles of platinum doublet chemotherapy; after progression on platinum chemotherapy [1] | CheckMate 816 trial [3] |
| Malignant pleural mesothelioma | First line for unresectable disease, with ipilimumab [1] | FDA label [1] |
| Kidney cancer (renal cell carcinoma) | First line for advanced disease with ipilimumab (intermediate or poor risk) or with cabozantinib; monotherapy after prior anti-angiogenic therapy [1] | CheckMate 214 trial [4]; CheckMate 9ER trial [5] |
| Classical Hodgkin lymphoma | Untreated stage III or IV with doxorubicin, vinblastine and dacarbazine (AVD) in adults and children aged 12 and over; monotherapy for relapse or progression after autologous transplant and brentuximab vedotin, or after 3 or more lines of systemic therapy including autologous transplant [1] | SWOG S1826 trial [6] |
| Head and neck cancer (squamous cell carcinoma) | Recurrent or metastatic disease progressing during or after platinum therapy [1] | CheckMate 141 trial [7] |
| Bladder and urinary tract (urothelial) cancer | Adjuvant treatment after radical surgery in patients at high risk of recurrence; first line for unresectable or metastatic disease with cisplatin and gemcitabine; advanced disease after platinum chemotherapy or progression within 12 months of perioperative platinum chemotherapy [1] | CheckMate 274 trial [8] |
| MSI-H or dMMR colorectal cancer | Unresectable or metastatic disease with ipilimumab; monotherapy for metastatic disease after a fluoropyrimidine, oxaliplatin and irinotecan; adults and children aged 12 and over [1] | CheckMate 8HW trial [9] |
| Hepatocellular carcinoma | Unresectable or metastatic disease with ipilimumab, first line or after prior sorafenib [1] | CheckMate 9DW trial [10] |
| Oesophageal cancer | Adjuvant treatment after complete resection of oesophageal or gastro-oesophageal junction cancer with residual pathological disease after preoperative chemoradiotherapy; first line for advanced squamous cell carcinoma with PD-L1 ≥1 with fluoropyrimidine and platinum chemotherapy or with ipilimumab; squamous cell carcinoma after prior fluoropyrimidine and platinum chemotherapy [1] | CheckMate 577 trial [11] |
| Gastric, gastro-oesophageal junction and oesophageal adenocarcinoma | Advanced or metastatic disease with PD-L1 ≥1, with fluoropyrimidine and platinum chemotherapy [1] | CheckMate 649 trial [12] |
A summary of the FDA label; the full label has the exact details and age limits of each use. For squamous oesophageal cancer and gastric cancer, no FDA-approved companion diagnostic for PD-L1 is available.
How it is taken and dosing
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Treatment regimens and doses: index15 regimens
Nivolumab is given at a treatment centre as an intravenous drip over about 30 minutes [1]. Depending on the cancer, the dose and whether it is given alone or with other drugs, it is usually given every 2, 3 or 4 weeks [1]. When it is given with ipilimumab, nivolumab is given first and then ipilimumab on the same day [1].
Duration: as adjuvant treatment of melanoma and bladder cancer, up to 1 year; as adjuvant treatment of oesophageal cancer, 1 year in total; and in many uses for advanced disease, until the disease progresses or side effects cannot be tolerated (up to 2 years in some combinations) [1].
Tests: liver enzymes, creatinine and thyroid function are checked before starting and regularly during treatment [1].
- Before starting: baseline liver enzymes, creatinine and thyroid function; confirm pregnancy status. Patient selection: PD-L1 in NSCLC (with ipilimumab without chemotherapy), ESCC and gastric/GEJ/oesophageal adenocarcinoma [1].
- Infusion: dilute in 0.9% saline or 5% dextrose (1 to 10 mg/mL; total volume no more than 160 mL, and in patients under 40 kg no more than 4 mL/kg), infuse over 30 minutes with a 0.2 to 1.2 µm in-line filter, through a separate line. Order: nivolumab before ipilimumab and chemotherapy; with AVD, nivolumab last. Grade 1 to 2 infusion reaction: interrupt or slow the rate; grade 3 to 4: discontinue permanently [1].
- Dose modification: no dose reductions are recommended. Grade 2 pneumonitis: withhold; grade 3 to 4: discontinue. Grade 2 to 3 colitis: withhold; grade 4: discontinue (with ipilimumab, discontinue for grade 3 to 4). Hepatitis without liver involvement: ALT/AST above 3 to 8 times ULN or bilirubin above 1.5 to 3 times: withhold; ALT/AST above 8 times or bilirubin above 3 times: discontinue (with ipilimumab the thresholds are 3 to 5 and above 5 times). Nephritis (grade 2 to 3 creatinine): withhold; grade 4: discontinue. Grade 2 to 4 myocarditis: discontinue. Grade 2 neurological toxicity: withhold; grade 3 to 4: discontinue. Suspected SJS/TEN/DRESS: withhold; confirmed: discontinue. Grade 3 to 4 endocrinopathy: withhold until stable or discontinue. Discontinue permanently for a grade 4 immune-related adverse reaction, recurrent grade 3 requiring immunosuppression, or inability to taper prednisone to 10 mg/day within 12 weeks. With ipilimumab, both drugs are withheld or discontinued together [1].
- Kidney and liver: renal impairment (eGFR 15 mL/min/1.73 m² or more) and mild to moderate hepatic impairment (bilirubin up to 3 times ULN) have no important effect on clearance; severe hepatic impairment has not been studied [1].
- Monitoring: liver enzymes, creatinine and thyroid periodically; symptoms of pneumonitis, colitis, adrenal insufficiency, hypophysitis and type 1 diabetes [1].
For physicians
Standard dosing: nivolumab monotherapy (FDA label, revised 05/2026)
Monotherapy
Unresectable/metastatic and adjuvant melanoma; metastatic NSCLC after platinum; RCC after anti-angiogenic therapy; relapsed Hodgkin lymphoma; SCCHN after platinum; adjuvant or post-platinum urothelial cancer; MSI-H/dMMR colorectal cancer after a fluoropyrimidine, oxaliplatin and irinotecan; ESCC after chemotherapy; adjuvant oesophageal/GEJ cancerCycle length: 14 or 28 days
Unresectable/metastatic and adjuvant melanoma; metastatic NSCLC after platinum; RCC after anti-angiogenic therapy; relapsed Hodgkin lymphoma; SCCHN after platinum; adjuvant or post-platinum urothelial cancer; MSI-H/dMMR colorectal cancer after a fluoropyrimidine, oxaliplatin and irinotecan; ESCC after chemotherapy; adjuvant oesophageal/GEJ cancer [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks | IV, 30-minute infusion | Day 1 |
Children aged 12 and over weighing less than 40 kg (melanoma): 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks; colorectal: 3 mg/kg every 2 weeks [1].
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Combination regimens with chemotherapy or cabozantinib (FDA label, revised 05/2026)
Resectable NSCLC, neoadjuvant (CheckMate 816)
Tumour of 4 cm or larger or N+Cycle length: 21 days
Tumour of 4 cm or larger or N+ [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| 3 cycles | |||
| Nivolumab | 360 mg | IV, 30-minute infusion | Day 1 every 3 weeks |
| Platinum doublet chemotherapy | As per those drugs' labels | IV | Same day, after nivolumab |
Evidence: CheckMate 816 (2025)
Resectable NSCLC, before and after surgery (CheckMate 77T)
Tumour of 4 cm or larger or N+, without known EGFR/ALK
Tumour of 4 cm or larger or N+, without known EGFR/ALK [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Neoadjuvant: up to 4 cycles | |||
| Nivolumab | 360 mg | IV, 30-minute infusion | Day 1 every 3 weeks |
| Platinum doublet chemotherapy | As per those drugs' labels | IV | Same day, after nivolumab |
| Adjuvant: up to 13 cycles | |||
| Nivolumab | 480 mg | IV, 30-minute infusion | Every 4 weeks |
Advanced RCC, with cabozantinib (CheckMate 9ER)
First lineCycle length: 14 or 28 days
First line [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks | IV, 30-minute infusion | Day 1 |
| Cabozantinib | 40 mg | Oral, fasting | Once daily |
ALT/AST above 3 to 10 times ULN with bilirubin below 2 times: withhold both drugs until grade 0 to 1; above 10 times, or above 3 times with bilirubin 2 times or more: discontinue both permanently [1].
Evidence: CheckMate 9ER (2026), CheckMate 9ER (2021)
Untreated stage III or IV classical Hodgkin lymphoma (with AVD, SWOG S1826)
Adults and children aged 12 and overCycle length: 14 days
Adults and children aged 12 and over [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| 6 cycles | |||
| Doxorubicin, vinblastine, dacarbazine (AVD) | As per those drugs' labels | IV | Before nivolumab |
| Nivolumab | 240 mg (below 40 kg: 3 mg/kg) | IV, 30-minute infusion | Every 2 weeks (given last) |
G-CSF prophylaxis from cycle 1 is recommended [1].
Evidence: SWOG S1826 (2024)
Unresectable or metastatic urothelial carcinoma, with cisplatin and gemcitabine (CheckMate 901)
First line
First line [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Combination: up to 6 cycles | |||
| Nivolumab | 360 mg | IV, 30-minute infusion | Day 1 every 3 weeks (given first) |
| Cisplatin + gemcitabine | As per those drugs' labels | IV | Same day, after nivolumab |
| Monotherapy after the combination | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks | IV, 30-minute infusion | Starting after the combination doses |
Evidence: CheckMate 901 (2023)
Advanced ESCC with PD-L1 1 or more, with chemotherapy (CheckMate 648)
First line, with a fluoropyrimidine and platinumCycle length: 14 or 28 days
First line, with a fluoropyrimidine and platinum [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks | IV, 30-minute infusion | Day 1 (given first) |
| Fluoropyrimidine + platinum | As per those drugs' labels | IV | Same day, after nivolumab |
Evidence: CheckMate 648 (2026), CheckMate 648 (2022)
Advanced gastric, GEJ or oesophageal adenocarcinoma with PD-L1 1 or more (CheckMate 649)
With fluoropyrimidine and platinum chemotherapyCycle length: 14 or 21 days
With fluoropyrimidine and platinum chemotherapy [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Nivolumab | 240 mg every 2 weeks (with 2-weekly chemotherapy) or 360 mg every 3 weeks (with 3-weekly chemotherapy) | IV, 30-minute infusion | Day 1 (given first) |
| Fluoropyrimidine + platinum | As per those drugs' labels | IV | Same day, after nivolumab |
Evidence: CheckMate 649 (2026), CheckMate 649 (2021)
Before prescribing, check each dose against the drug label, laboratory tests and the patient’s condition.
Combination regimens with ipilimumab (FDA label, revised 05/2026)
Unresectable or metastatic melanoma, with ipilimumab
Adults and children aged 12 and over
Adults and children aged 12 and over [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Combination: 4 doses | |||
| Nivolumab | 1 mg/kg | IV, 30-minute infusion | Every 3 weeks (given first) |
| Ipilimumab | 3 mg/kg | IV, 30-minute infusion | Same day, after nivolumab |
| Monotherapy after the combination | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks | IV, 30-minute infusion | Starting after the combination doses |
Below 40 kg in the monotherapy phase: 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks [1].
Metastatic NSCLC, with ipilimumab ± 2 cycles of chemotherapy
First line, without EGFR/ALK; without chemotherapy only with PD-L1 1% or moreEach drug’s schedule in the table
First line, without EGFR/ALK; without chemotherapy only with PD-L1 1% or more [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Nivolumab | 360 mg | IV, 30-minute infusion | Every 3 weeks |
| Ipilimumab | 1 mg/kg | IV, 30-minute infusion | Every 6 weeks |
| In the regimen with chemotherapy: 2 cycles | |||
| Histology-based platinum doublet chemotherapy | As per those drugs' labels | IV | Every 3 weeks, after nivolumab and ipilimumab |
Unresectable malignant pleural mesothelioma
First line, with ipilimumabEach drug’s schedule in the table
First line, with ipilimumab [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Nivolumab | 360 mg | IV, 30-minute infusion | Every 3 weeks |
| Ipilimumab | 1 mg/kg | IV, 30-minute infusion | Every 6 weeks |
Advanced intermediate- or poor-risk RCC, with ipilimumab
First line
First line [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Combination: 4 doses | |||
| Nivolumab | 3 mg/kg | IV, 30-minute infusion | Every 3 weeks (given first) |
| Ipilimumab | 1 mg/kg | IV, 30-minute infusion | Same day, after nivolumab |
| Monotherapy after the combination | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks | IV, 30-minute infusion | Starting after the combination doses |
Unresectable or metastatic MSI-H/dMMR colorectal cancer, with ipilimumab
Adults and children aged 12 and over
Adults and children aged 12 and over [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Combination: up to 4 doses | |||
| Nivolumab | 240 mg (below 40 kg: 3 mg/kg) | IV, 30-minute infusion | Every 3 weeks (given first) |
| Ipilimumab | 1 mg/kg | IV, 30-minute infusion | Same day, after nivolumab |
| Monotherapy after the combination | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks (below 40 kg: 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks) | IV, 30-minute infusion | Starting after the combination doses |
Unresectable or metastatic hepatocellular carcinoma, with ipilimumab
First line or after sorafenib
First line or after sorafenib [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Combination: up to 4 doses | |||
| Nivolumab | 1 mg/kg | IV, 30-minute infusion | Every 3 weeks (given first) |
| Ipilimumab | 3 mg/kg | IV, 30-minute infusion | Same day, after nivolumab |
| Monotherapy after the combination | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks | IV, 30-minute infusion | Starting after the combination doses |
Advanced ESCC with PD-L1 1 or more, with ipilimumab
First lineCycle length: 14 or 21 days
First line [1]
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Nivolumab | 3 mg/kg every 2 weeks or 360 mg every 3 weeks | IV, 30-minute infusion | Day 1 |
| Ipilimumab | 1 mg/kg | IV, 30-minute infusion | Every 6 weeks |
Before prescribing, check each dose against the drug label, laboratory tests and the patient’s condition.
Side effects
Common side effects
The most common side effects:
- Tiredness, skin rash and itching, muscle and joint pain, diarrhoea and nausea [1].
- Cough, shortness of breath, poor appetite, constipation and fever [1].
- An underactive thyroid (tiredness, feeling cold, weight gain), treated with thyroid tablets [1].
- When given with ipilimumab, side effects are more common and more severe [1].
- Report any new or worsening symptom early; it may be the first sign of an immune side effect [1].
For physicians
According to the FDA label, the most common adverse reactions to nivolumab alone (20% or more) are fatigue, rash, musculoskeletal pain, pruritus, diarrhoea, nausea, asthenia, cough, dyspnoea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, vomiting and urinary tract infection [1].
In combination with ipilimumab, hypothyroidism, weight loss and dizziness are also among the common adverse reactions [1]. The table below shows the frequency of some adverse reactions in CheckMate 067 (untreated advanced melanoma) for the nivolumab monotherapy arm and the nivolumab plus ipilimumab arm (313 patients each) [1].
| Adverse reaction | Nivolumab monotherapy | Nivolumab + ipilimumab |
|---|---|---|
| Fatigue | 59% [1] | 62% [1] |
| Musculoskeletal pain | 42% [1] | 32% [1] |
| Rash | 40% [1] | 53% [1] |
| Diarrhoea | 36% [1] | 54% [1] |
| Nausea | 30% [1] | 44% [1] |
| Cough | 28% [1] | 27% [1] |
| Decreased appetite | 22% [1] | 29% [1] |
| Arthralgia | 21% [1] | 21% [1] |
| Vomiting | 20% [1] | 31% [1] |
| Pyrexia | 16% [1] | 40% [1] |
| Hypothyroidism | 11% [1] | 19% [1] |
In this trial, grade 3 or 4 adverse reactions occurred in 72% of the combination arm vs 51% of the nivolumab monotherapy arm [1].
Serious side effects
Immunotherapy sometimes makes the immune system attack healthy organs too. These side effects can happen at any time, even after treatment has ended [1] (immunotherapy side effects):
- Lungs: a new cough, shortness of breath or chest pain [1].
- Bowel: diarrhoea, abdominal pain or blood in the stool [1].
- Liver: yellow skin or eyes, dark urine [1].
- Glands: severe tiredness, dizziness, severe headache, thirst and passing a lot of urine [1].
- Kidneys and skin: passing less urine, a widespread rash or blisters [1].
- A reaction during the infusion and harm to an unborn baby [1].
For physicians
Serious adverse reactions to nivolumab are mainly immune-related adverse reactions, which can occur in any organ, can be severe or fatal and can appear even after treatment is stopped [1]. The frequencies below are for 1994 patients receiving nivolumab monotherapy in clinical trials [1]:
- Pneumonitis: 3.1% [1]; with ipilimumab in lung cancer: 9% [1].
- Colitis: 2.9%; cytomegalovirus infection or reactivation has been reported in corticosteroid-refractory colitis [1].
- Immune-mediated hepatitis: 1.8% [1].
- Thyroid disorders: hypothyroidism 8%, hyperthyroidism 2.7% and thyroiditis 0.6% [1].
- Other endocrinopathies: adrenal insufficiency 1%, diabetes 0.9% (including two cases of diabetic ketoacidosis) and hypophysitis 0.6% [1].
- Nephritis and renal dysfunction: 1.2%; immune-mediated rash: 9% [1].
- Infusion-related reactions: 6.4% with 60-minute infusion; in a comparative study, 2.2% with 60-minute and 2.7% with 30-minute infusion [1].
Immune-related adverse reactions are more common with ipilimumab [1]. Allogeneic stem cell transplantation before or after treatment may be associated with serious or fatal complications [1]. Adding a PD-1 inhibitor to a thalidomide analogue and dexamethasone in multiple myeloma increased mortality and is not recommended outside a clinical trial [1]. Nivolumab can harm a fetus [1]. The FDA label for this drug has no boxed warning [1].
When should I call my doctor?
If you have any of these new or worsening symptoms, contact your doctor or treatment team straight away, even if treatment has finished [1]:
- A new or worsening cough, chest pain or shortness of breath [1]
- Diarrhoea or more frequent bowel movements, black tarry stools or stools with blood or mucus, or severe abdominal pain [1]
- Yellow skin or whites of the eyes, severe nausea or vomiting, pain on the right side of the abdomen, dark urine, or bleeding and bruising easily [1]
- A persistent or unusual headache, eye sensitivity to light, palpitations, heavy sweating, extreme tiredness, weight change, excessive thirst or hunger, passing a lot of urine, dizziness or fainting [1]
- Passing less urine, blood in the urine or swollen ankles [1]
- Rash, itching, blistering or peeling skin, painful sores in the mouth or genital area, fever or flu-like symptoms [1]
- An irregular heartbeat, confusion, a stiff neck, double or blurred vision, or severe muscle pain and weakness [1]
- During the infusion: chills, itching or rash, flushing, shortness of breath or wheezing, dizziness, feeling faint, fever, or back or neck pain [1]
In severe cases (such as severe shortness of breath, severe chest pain or reduced consciousness), call your local emergency number.
Interactions, pregnancy and precautions
Drug interactions: the FDA label for nivolumab has no section on drug interactions [1]; even so, tell your doctor about all your medicines, over-the-counter drugs, vitamins and herbal supplements [1].
Before starting treatment, tell your doctor if you have an autoimmune disease (such as Crohn disease, ulcerative colitis or lupus), have had an organ or corneal transplant, a stem cell transplant from a donor, chest radiotherapy together with drugs similar to nivolumab, or a nerve disease such as myasthenia gravis or Guillain-Barré syndrome [1].
Pregnancy and contraception: nivolumab may harm an unborn baby. Pregnancy status is checked before starting, and women who could become pregnant should use effective contraception during treatment and for 5 months after the last dose [1].
Breastfeeding: do not breastfeed during treatment and for 5 months after the last dose [1].
Fertility: no studies have looked at the effect of nivolumab on fertility [1]; if you are planning a family, talk to your doctor before starting treatment.
Vaccines: the FDA label gives no specific advice about vaccination [1]; talk to your treatment team before any vaccine.
Missed appointment: if you miss an appointment, contact your treatment team as soon as possible to arrange a new one [1].
Frequently asked questions
Is nivolumab chemotherapy?
What is the difference between nivolumab alone and with ipilimumab?
Can side effects start after treatment has ended?
Yes. Immune-related side effects usually appear during treatment, but they can also appear after the drug is stopped [1].
Are special tests needed before getting nivolumab?
In some uses, yes: for example, in metastatic lung cancer with ipilimumab, squamous oesophageal cancer and stomach cancer, PD-L1 expression is checked, and in bowel cancer, MSI-H/dMMR status [1].
Scientific evidence
Show detailsHide
Key studies
10 itemsOverall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer
Nivolumab+AVD in Advanced-Stage Classic Hodgkin's Lymphoma
Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma
Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer
Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma
Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer
Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial
Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma
Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma
First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial
Related cancer types
Treatment regimens (physicians)
References
12 referencesShow all references, 11 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1OPDIVO (nivolumab) injection, for intravenous use: Prescribing InformationSource Back to text: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156
- 2Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma
- 3Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer
- 4Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma
- 5Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma
- 6Nivolumab+AVD in Advanced-Stage Classic Hodgkin's Lymphoma
- 7Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck
- 8Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma
- 9Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer
- 10Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial
- 11Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer
- 12First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial
This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
Printed from the website; the full and up-to-date version: https://drdabiri.com/en/drugs/nivolumab/