OPDIVO (Nivolumab)
PD-1 Immune Checkpoint Inhibitor for Cancer Treatment
OPDIVO (nivolumab) is a prescription immunotherapy medicine that helps the body's immune system fight cancer. It belongs to a class of drugs called PD-1 checkpoint inhibitors and is used to treat multiple types of cancer including melanoma, lung cancer, kidney cancer, and several other malignancies. Administered as a subcutaneous injection, OPDIVO works by blocking the PD-1 receptor on T-cells, restoring the immune system's ability to detect and destroy cancer cells.
Quick Facts
Key Takeaways
- OPDIVO (nivolumab) is a PD-1 immune checkpoint inhibitor used to treat over 10 different types of cancer, including melanoma, non-small cell lung cancer, renal cell carcinoma, and esophageal cancer.
- It works by blocking the PD-1 receptor on T-cells, preventing cancer cells from evading the immune system and restoring anti-tumor immune activity.
- Common side effects include fatigue, rash, diarrhea, and musculoskeletal pain; serious immune-mediated adverse reactions require immediate medical attention.
- OPDIVO is administered as a subcutaneous injection (600 mg every 2 weeks or 1,200 mg every 4 weeks) and can be given alone or in combination with other cancer treatments.
- Treatment should only be initiated and supervised by an experienced oncologist, and patients require regular monitoring through blood tests and clinical assessments.
What Is OPDIVO and What Is It Used For?
OPDIVO contains the active substance nivolumab, a human monoclonal antibody—a type of protein specifically designed to recognize and bind to particular target substances in the body. Nivolumab targets the programmed death-1 (PD-1) receptor, a protein found on the surface of T-cells (a type of white blood cell that forms a critical part of the immune system). Many cancer cells exploit the PD-1 pathway to evade immune surveillance by producing ligands (PD-L1 and PD-L2) that bind to PD-1 and effectively switch off T-cell activity. By blocking PD-1, nivolumab prevents this immune evasion, restoring the T-cells' ability to recognize and destroy cancer cells.
This mechanism of action—known as immune checkpoint inhibition—represents one of the most significant advances in cancer treatment in recent decades. Unlike traditional chemotherapy that directly kills rapidly dividing cells, OPDIVO harnesses the patient's own immune system to fight cancer. This targeted immunological approach was recognized with the Nobel Prize in Physiology or Medicine in 2018, awarded to James P. Allison and Tasuku Honjo for their discovery of cancer therapy by inhibition of negative immune regulation.
OPDIVO is approved for the treatment of a wide range of cancers in adults. These include:
- Melanoma: Advanced melanoma (a type of skin cancer) and as adjuvant therapy after complete surgical resection of melanoma
- Non-small cell lung cancer (NSCLC): Advanced NSCLC, as well as neoadjuvant (before surgery) and adjuvant (after surgery) treatment
- Renal cell carcinoma: Advanced kidney cancer
- Head and neck squamous cell carcinoma: Advanced head and neck cancer
- Urothelial carcinoma: Advanced bladder and urinary tract cancer, and as adjuvant therapy after surgical removal
- Colorectal cancer: Advanced colon or rectal cancer
- Esophageal cancer: Advanced esophageal cancer, and cancer of the gastroesophageal junction with residual pathological disease after chemoradiotherapy followed by surgery
- Gastric cancer: Advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma
- Hepatocellular carcinoma: Unresectable or advanced liver cell cancer
OPDIVO can be given as monotherapy (alone) or in combination with other cancer medicines, including ipilimumab (a CTLA-4 checkpoint inhibitor), chemotherapy, or cabozantinib (a tyrosine kinase inhibitor). The choice of treatment regimen depends on the type and stage of cancer, previous treatments received, and specific biomarker characteristics such as PD-L1 expression and microsatellite instability (MSI) status. When OPDIVO is prescribed in combination with other drugs, patients should also read the package leaflets for those medicines.
What Should You Know Before Taking OPDIVO?
Contraindications
OPDIVO must not be administered to patients with a known hypersensitivity to nivolumab or to any of the excipients listed in the formulation (including polysorbat 80, histidine, sucrose, pentetate, methionine, and recombinant human hyaluronidase). If you are uncertain whether you have any allergies to these substances, consult your physician before starting treatment. Allergic reactions to OPDIVO, including life-threatening anaphylactic reactions, have been reported and require immediate medical intervention.
Warnings and Precautions
OPDIVO acts on the immune system and can cause inflammation in various parts of the body. These immune-mediated adverse reactions can be serious and sometimes life-threatening. It is essential to be aware of the following potential complications and to report any symptoms to your healthcare provider promptly:
OPDIVO can cause immune-mediated adverse reactions that may be severe or fatal. Contact your doctor immediately if you experience any new or worsening symptoms. Do not attempt to treat symptoms on your own with other medications.
- Heart problems: Changes in heart rhythm, heart rate, or abnormal heart rhythm (myocarditis, pericardial disorders)
- Lung inflammation (pneumonitis): Breathing difficulties or persistent cough
- Intestinal inflammation (colitis): Diarrhea, abdominal pain, mucus or blood in stool
- Liver inflammation (hepatitis): Abnormal liver function tests, jaundice, right-sided abdominal pain, fatigue
- Kidney problems (nephritis): Abnormal kidney function tests, decreased urine output
- Endocrine disorders: Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, diabetes (including diabetic ketoacidosis)
- Severe skin reactions: Toxic epidermal necrolysis and Stevens-Johnson syndrome (potentially fatal)
- Muscle inflammation: Myocarditis, myositis, rhabdomyolysis
- Organ transplant rejection
- Graft-versus-host disease
- Hemophagocytic lymphohistiocytosis (HLH): A rare disorder where the immune system produces excessive infection-fighting cells
These signs and symptoms may be delayed and can develop weeks or months after the last dose. Before treatment, your doctor will assess your overall health through blood tests and clinical examinations, which will continue throughout your treatment course. Your doctor may prescribe corticosteroids to reduce symptoms, delay your next dose, or permanently discontinue OPDIVO treatment depending on the severity of the reaction.
- Have an autoimmune disease (a condition where the body attacks its own cells)
- Have uveal (eye) melanoma
- Have previously received ipilimumab and experienced serious side effects
- Have been told your cancer has spread to the brain
- Have had previous lung inflammation
- Are taking medicines that suppress your immune system
- Have had or are planning an organ or stem cell transplant
Pregnancy and Breastfeeding
OPDIVO should not be used during pregnancy unless your doctor specifically instructs you to do so. The effects of nivolumab in pregnant women are not fully known, but the active substance may potentially harm an unborn baby based on its mechanism of action. Women of childbearing potential must use effective contraception during treatment and for at least 5 months after the last dose of OPDIVO.
It is not known whether nivolumab passes into breast milk. A risk to the breastfed infant cannot be excluded. Discuss with your doctor whether you can breastfeed during or after treatment with OPDIVO. If you become pregnant during treatment, inform your healthcare provider immediately.
Children and Adolescents
OPDIVO solution for injection should not be used in children and adolescents under 18 years of age. The safety and efficacy of nivolumab in the pediatric population have not been established for this formulation.
Driving and Using Machines
OPDIVO, or OPDIVO in combination with ipilimumab, may have a minor effect on the ability to drive and use machines. Exercise caution until you are confident that OPDIVO does not adversely affect your concentration or reaction time. Common side effects such as fatigue and dizziness may impair your ability to operate vehicles or machinery safely.
How Does OPDIVO Interact with Other Drugs?
Drug interactions with OPDIVO differ fundamentally from those of conventional chemotherapy because nivolumab is a monoclonal antibody that does not undergo metabolism by cytochrome P450 enzymes. Instead, the primary concern involves medications that modify immune function. Systemic immunosuppressants administered before starting nivolumab may interfere with its pharmacodynamic activity and reduce its therapeutic efficacy, as OPDIVO's mechanism depends on a functional immune response.
Once treatment with OPDIVO has been initiated, corticosteroids and other immunosuppressive agents can be used to manage immune-mediated adverse reactions without significantly compromising the anti-tumor efficacy of the drug. This is an important clinical distinction: corticosteroids given to treat immune-related side effects during therapy do not negate the benefit of treatment.
Major Interactions
| Interacting Drug | Effect | Clinical Advice |
|---|---|---|
| Systemic corticosteroids (before treatment) | May reduce OPDIVO efficacy by suppressing immune activation | Avoid systemic corticosteroids before initiating nivolumab; taper off if possible |
| Other immunosuppressants (e.g., methotrexate, azathioprine) | May interfere with OPDIVO's mechanism of action | Inform oncologist of all immunosuppressive medications; dosage adjustment may be needed |
| Live vaccines | Risk of infection due to altered immune response | Avoid live vaccines during treatment; inactivated vaccines may be used with caution |
Combination Therapies
OPDIVO is frequently administered in combination with other anti-cancer agents. When given with ipilimumab (a CTLA-4 inhibitor), the combination provides dual checkpoint inhibition that can enhance anti-tumor responses but also increases the risk and severity of immune-mediated adverse reactions. Patients receiving combination therapy require closer monitoring compared to monotherapy.
When OPDIVO is combined with chemotherapy agents (such as platinum-based regimens for lung or esophageal cancer) or with cabozantinib (for renal cell carcinoma), the side effect profiles of all medications must be considered. Patients should always inform their healthcare provider of any new medications, including over-the-counter drugs and herbal supplements, before and during treatment.
What Is the Correct Dosage of OPDIVO?
OPDIVO dosing is weight-independent for monotherapy and most combination regimens, simplifying preparation and administration. The drug is given as a subcutaneous injection in the abdomen or thigh over 3 to 5 minutes. Treatment continues for as long as clinical benefit is observed or until the patient can no longer tolerate the therapy. Your physician will determine the most appropriate dosing schedule based on your cancer type and treatment regimen.
Adult Dosage by Indication
Monotherapy (OPDIVO alone)
600 mg subcutaneously every 2 weeks or 1,200 mg subcutaneously every 4 weeks. This applies to all monotherapy indications including adjuvant melanoma, adjuvant NSCLC, adjuvant urothelial carcinoma, and advanced cancers after the combination phase.
Combination with Ipilimumab (Melanoma)
Combination phase: Nivolumab 1 mg/kg intravenously every 3 weeks for 4 doses, combined with ipilimumab.
Monotherapy phase: 600 mg subcutaneously every 2 weeks or 1,200 mg every 4 weeks.
Combination with Ipilimumab (Renal Cell Carcinoma)
Combination phase: Nivolumab 3 mg/kg intravenously every 3 weeks for 4 doses, combined with ipilimumab.
Monotherapy phase: 600 mg subcutaneously every 2 weeks or 1,200 mg every 4 weeks.
Combination with Ipilimumab (Colorectal Cancer / Hepatocellular Carcinoma)
Combination phase: Nivolumab 3 mg/kg or 1 mg/kg intravenously every 3 weeks for up to 4 doses, combined with ipilimumab (dose varies by indication).
Monotherapy phase: 600 mg subcutaneously every 2 weeks or 1,200 mg every 4 weeks.
Combination with Chemotherapy (Esophageal / Gastric Cancer)
600 mg subcutaneously every 2 weeks or 1,200 mg every 4 weeks (esophageal cancer), or 600 mg every 2 weeks (gastric/GEJ/esophageal adenocarcinoma), in combination with chemotherapy.
Neoadjuvant + Adjuvant NSCLC
Neoadjuvant (before surgery): 360 mg intravenously every 3 weeks for 4 cycles with platinum-based chemotherapy.
Adjuvant (after surgery): 1,200 mg subcutaneously every 4 weeks.
Combination with Cabozantinib (Renal Cell Carcinoma)
Nivolumab 600 mg subcutaneously every 2 weeks or 1,200 mg every 4 weeks, combined with cabozantinib 40 mg orally once daily.
Missed Dose
It is very important to attend all scheduled appointments for OPDIVO administration. If you miss an appointment, contact your doctor as soon as possible to reschedule your next dose. Do not attempt to double up on doses or modify the treatment schedule without medical guidance. Consistent dosing intervals are essential for maintaining therapeutic drug levels and optimal treatment outcomes.
Stopping Treatment
Do not stop OPDIVO treatment without first discussing it with your oncologist. Discontinuing treatment prematurely may reduce the effectiveness of the therapy. Your doctor may decide to stop treatment if you experience severe immune-mediated side effects, if the cancer progresses, or if you can no longer tolerate the treatment. The decision to continue or stop treatment should always be made in partnership with your healthcare team.
What Are the Side Effects of OPDIVO?
OPDIVO affects the immune system and can cause inflammation in various parts of the body. These inflammatory reactions are a consequence of the drug's mechanism of action—by releasing the brakes on the immune system, OPDIVO can sometimes trigger the immune system to attack healthy tissues in addition to cancer cells. While most side effects are manageable with appropriate medical intervention, some immune-mediated adverse reactions can be severe, life-threatening, or fatal if not treated promptly.
The following side effects have been reported with OPDIVO when used as monotherapy:
OPDIVO Monotherapy Side Effects
Very Common
May affect more than 1 in 10 patients
- Upper respiratory tract infections
- Decreased red blood cells, white blood cells, or platelets
- Decreased appetite, high blood sugar (hyperglycemia)
- Headache
- Shortness of breath (dyspnea), cough
- Diarrhea, vomiting, nausea, abdominal pain, constipation
- Skin rash (sometimes with blisters), itching
- Musculoskeletal pain, joint pain (arthralgia)
- Fatigue, weakness, fever
Common
May affect up to 1 in 10 patients
- Pneumonia, bronchitis
- Infusion-related reactions, allergic reactions (including life-threatening)
- Hypothyroidism, hyperthyroidism, thyroid swelling
- Dehydration, weight loss, low blood sugar (hypoglycemia)
- Nerve inflammation (numbness, weakness, tingling), dizziness
- Blurred vision, dry eyes
- Rapid heartbeat, abnormal heart rhythm, high blood pressure
- Pneumonitis (lung inflammation), fluid around the lungs
- Colitis (intestinal inflammation), mouth sores, dry mouth
- Vitiligo, dry skin, redness, hair loss
- Joint inflammation (arthritis)
- Kidney failure, pain, chest pain, edema (swelling)
- Injection site reactions
Uncommon
May affect up to 1 in 100 patients
- Sarcoidosis
- Adrenal insufficiency, hypopituitarism, hypophysitis, diabetes
- Metabolic acidosis
- Polyneuropathy, autoimmune neuropathy
- Eye inflammation
- Myocarditis (heart muscle inflammation), pericardial disorders
- Pancreatitis, gastritis
- Hepatitis, cholestasis
- Psoriasis, rosacea, erythema multiforme, urticaria
- Polymyalgia rheumatica
Rare
May affect up to 1 in 1,000 patients
- Aseptic meningitis
- Diabetic ketoacidosis, hypoparathyroidism
- Guillain-Barré syndrome, demyelination, myasthenic syndrome, encephalitis
- Optic neuritis
- Vasculitis (blood vessel inflammation)
- Toxic epidermal necrolysis, Stevens-Johnson syndrome (potentially fatal)
- Sjögren's syndrome, myopathy, myositis, rhabdomyolysis
- Nephritis, cystitis
- Exocrine pancreatic insufficiency, celiac disease
- Myelitis/transverse myelitis, lichen sclerosus
Additional Side Effects with Combination Therapy
When OPDIVO is given in combination with other anti-cancer medications (such as ipilimumab, chemotherapy, or cabozantinib), the frequency and severity of side effects may increase. Combination therapy can produce additional or more severe side effects compared to monotherapy. These may include:
- More frequent and severe endocrine disorders (thyroid dysfunction, adrenal insufficiency, hypophysitis)
- Higher rates of gastrointestinal toxicity (diarrhea, colitis, pancreatitis)
- Increased liver toxicity (hepatitis, elevated liver enzymes)
- Hand-foot syndrome (pain, redness, and swelling of palms and soles) when combined with chemotherapy
- Thrombosis (blood clots), nosebleeds, and voice disorders
- More pronounced fatigue, fever, and weight changes
Changes in Test Results
OPDIVO alone or in combination can cause changes in laboratory test results that your doctor monitors regularly. These include:
- Abnormal liver function tests (increased AST, ALT, GGT, alkaline phosphatase, bilirubin)
- Abnormal kidney function tests (increased creatinine)
- Increased lipase and amylase levels
- Changes in calcium, potassium, magnesium, and sodium levels
- Increased thyroid-stimulating hormone (TSH)
- Increased triglycerides and cholesterol
Contact your healthcare provider immediately if you experience: new or worsening cough or breathing difficulties, persistent diarrhea or blood in stool, yellowing of skin or eyes, severe skin rash or blistering, unusual muscle weakness or chest pain, severe headache or vision changes, decreased urine output, or signs of infection with high fever.
How Should You Store OPDIVO?
OPDIVO is a biological medicine that requires careful storage to maintain its stability and efficacy. The following storage conditions must be observed:
- Temperature: Store in a refrigerator at 2°C to 8°C (36°F to 46°F)
- Freezing: Do not freeze under any circumstances
- Light protection: Store in the original packaging to protect from light
- Expiry date: Do not use after the expiry date printed on the carton and vial label after “EXP”
- Unused solution: Do not save any unused portion for later use; discard according to local regulations
Once drawn into a syringe, the solution should be used immediately. If not used immediately, OPDIVO solution in a syringe can be stored refrigerated at 2°C to 8°C, protected from light, for up to 7 days, or at room temperature (20°C to 25°C) under room lighting for up to 8 hours. Keep all medicines out of the sight and reach of children.
As OPDIVO is administered by healthcare professionals in a clinical setting, patients generally do not need to store the medication at home. Your healthcare team is responsible for proper storage, preparation, and administration of the drug.
What Does OPDIVO Contain?
Active Ingredient
The active substance is nivolumab. Each milliliter of solution for injection contains 120 mg of nivolumab. Each vial contains 600 mg of nivolumab in 5 mL. Nivolumab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Other Ingredients (Excipients)
- Recombinant human hyaluronidase (rHuPH20) – facilitates subcutaneous delivery
- Histidine – buffer
- Histidine hydrochloride monohydrate – buffer
- Sucrose – stabilizer
- Pentetate (pentetic acid) – chelating agent
- Polysorbat 80 (E433) – surfactant (each 5 mL vial contains 2.5 mg)
- Methionine – antioxidant
- Water for injections
This medicine contains polysorbat 80, which may cause allergic reactions in some individuals. Inform your doctor if you have any known allergies to polysorbates.
Appearance and Packaging
OPDIVO solution for injection is a clear to opalescent, colorless to light yellow liquid that may contain a few light particles. It is available in a pack containing 1 glass vial with 5 mL of solution. The solution should not be used if it appears cloudy, discolored, or contains particles beyond a few translucent to white particles.
Marketing Authorization Holder and Manufacturer
OPDIVO is manufactured by Bristol-Myers Squibb. The marketing authorization holder is Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland. Manufacturing is carried out at Swords Laboratories Unlimited Company (t/a Bristol-Myers Squibb Cruiserath Biologics), Cruiserath Road, Mulhuddart, Dublin 15, D15 H6EF, Ireland.
Frequently Asked Questions About OPDIVO
OPDIVO (nivolumab) is a PD-1 checkpoint inhibitor used to treat multiple types of cancer including advanced melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (kidney cancer), head and neck squamous cell carcinoma, urothelial carcinoma (bladder cancer), colorectal cancer, esophageal cancer, gastric cancer, and hepatocellular carcinoma (liver cancer). It is also used as adjuvant therapy after surgical removal of melanoma, NSCLC, and urothelial carcinoma. OPDIVO works by blocking the PD-1 receptor on T-cells, restoring the immune system's ability to recognize and attack cancer cells.
The most common side effects of OPDIVO (affecting more than 1 in 10 patients) include fatigue or weakness, musculoskeletal pain, joint pain, skin rash, itching, diarrhea, nausea, vomiting, constipation, abdominal pain, decreased appetite, cough, shortness of breath, headache, fever, and upper respiratory tract infections. OPDIVO can also cause immune-mediated adverse reactions affecting the lungs, liver, intestines, kidneys, skin, and endocrine glands, which may be serious and require prompt medical attention.
OPDIVO is administered as a subcutaneous injection in the abdomen or thigh over 3 to 5 minutes. When used as monotherapy, the recommended dose is either 600 mg every 2 weeks or 1,200 mg every 4 weeks. When used in combination with ipilimumab, the initial doses are given as intravenous infusions over 30 minutes, followed by subcutaneous injections in the monotherapy maintenance phase. All treatments are administered under the supervision of an experienced oncologist in a clinical setting.
OPDIVO should not be used during pregnancy unless specifically advised by your doctor, as nivolumab may potentially harm an unborn baby. Women of childbearing potential must use effective contraception during treatment and for at least 5 months after the last dose. It is not known whether nivolumab passes into breast milk, so breastfeeding is not recommended during treatment. If you become pregnant during treatment, inform your healthcare provider immediately.
OPDIVO contains nivolumab, a human monoclonal antibody that targets the PD-1 (programmed death-1) receptor on T-cells. Many cancer cells produce proteins (PD-L1 and PD-L2) that bind to PD-1 and switch off T-cell activity, effectively hiding from the immune system. By blocking PD-1, nivolumab prevents cancer cells from disabling T-cells, restoring the immune system's natural ability to recognize and destroy cancer cells. This approach is called immune checkpoint inhibition and represents a major advancement in cancer treatment.
If you experience symptoms of immune-related side effects—such as new or worsening cough, shortness of breath, persistent diarrhea, abdominal pain, skin rash, yellowing of skin or eyes, unusual fatigue, headache, vision changes, or muscle weakness—contact your healthcare provider immediately. Do not attempt to treat these symptoms on your own. Your doctor may prescribe corticosteroids to reduce inflammation, delay your next dose, or permanently discontinue OPDIVO depending on the severity of the reaction. These side effects can occur during treatment or weeks to months after the last dose.
References
All information on this page is based on internationally recognized medical guidelines, regulatory documents, and peer-reviewed research:
- European Medicines Agency (EMA). OPDIVO Summary of Product Characteristics (SmPC). Updated 2025. Available at: www.ema.europa.eu/en/medicines/human/EPAR/opdivo
- U.S. Food and Drug Administration (FDA). OPDIVO Prescribing Information. Bristol-Myers Squibb Company. Updated 2025.
- Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019;381(16):1535-1546. doi:10.1056/NEJMoa1910836
- Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015;373(17):1627-1639. doi:10.1056/NEJMoa1507643
- Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015;373(19):1803-1813. doi:10.1056/NEJMoa1510665
- ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. European Society for Medical Oncology. Updated 2024.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Updated 2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023.
- Brahmer JR, Lacchetti C, Schneider BJ, et al. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update. J Clin Oncol. 2021;39(36):4073-4126. doi:10.1200/JCO.21.01440
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in oncology, immunotherapy, and clinical pharmacology.
iMedic Medical Editorial Team – Specialists in oncology, immunotherapy, and pharmacology with documented academic background and clinical experience.
iMedic Medical Review Board – Independent review according to EMA, FDA, ESMO, and NCCN guidelines. Evidence Level 1A (systematic reviews and randomized controlled trials).
All medical content follows the GRADE evidence framework. This article is based on regulatory approval documents (EMA SmPC, FDA Prescribing Information), published phase III clinical trial data, and international clinical practice guidelines from ESMO and NCCN. No commercial funding. Independent editorial content.