OPDIVO (nivolumab)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Pregnancy

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Hyperthyroidism
Hypothyroidism
Kidney disease with reduction in glomerular filtration rate (GFr)
Myasthenia gravis

There are 83 severe adverse reactions.

More Frequent

Less Frequent

Abnormal hepatic function tests Colitis Hyperkalemia Hypocalcemia Hypokalemia Hypomagnesemia Increased alanine transaminase Increased aspartate transaminase Lymphopenia Neutropenic disorder Thyroiditis

Acute respiratory failure Adrenocortical insufficiency Autoimmune hepatitis Bacterial sepsis Demyelinating disorder Gastrointestinal hemorrhage Hyperbilirubinemia Hypersensitivity drug reaction Interstitial lung disease Interstitial pneumonitis Kidney disease with reduction in glomerular filtration rate (GFr) Palmar-plantar erythrodysesthesia Pleural effusions Pneumonia Pulmonary thromboembolism Tracheoesophageal fistula

Rare/Very Rare

Acidosis Anemia Aplastic anemia Atrial fibrillation Autoimmune hemolytic anemia Cytokine release syndrome Cytomegalovirus disease Diabetes mellitus Diabetic ketoacidosis Duodenal ulcer Duodenitis Eaton-lambert syndrome Encephalitis Eosinophilia Erythema multiforme Exfoliative dermatitis Facial nerve disorder Gastrointestinal perforation Graft-versus-host disease Guillain-barre syndrome Hemolytic anemia Hemophagocytic lymphohistiocytosis Hemorrhage Hepatic failure Hepatitis Histiocytic necrotizing lymphadenitis Hypertension Hypophysitis Idiopathic thrombocytopenic purpura Interstitial nephritis Intestinal perforation Iridocyclitis Myasthenia gravis Myelitis Myocarditis Myopathy Myositis Organ transplant rejection Pancreatitis Pericarditis Pituitary insufficiency Polymyalgia rheumatica Pulmonary hemorrhage Renal failure Rhabdomyolysis Sarcoidosis Sepsis Sjogren's syndrome Spinal osteoarthritis Stevens-johnson syndrome Toxic epidermal necrolysis Tumor lysis syndrome Uveitis Vasculitis Ventricular arrhythmias Vogt-koyanagi-harada disease

There are 53 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Anorexia Arthralgia Back pain Constipation Cough Diarrhea Dysgeusia Dyspepsia Dyspnea Elevated serum lipase Fatigue Fever General weakness Headache disorder Hyperphosphatemia Hyponatremia Leukopenia Musculoskeletal pain Nasal congestion Nausea Peripheral edema Pruritus of skin Skin rash Upper respiratory infection Urinary tract infection Voice change Vomiting	Bronchitis Chills Dizziness Dry eye Dysphagia Edema Flushing Hyperglycemia Hyperthyroidism Hypothyroidism Muscle weakness Peripheral sensory neuropathy Stomatitis Tachycardia Vitiligo Weight loss

Rare/Very Rare
Arthritis Dehydration Elevated serum amylase Gastritis Iritis Nephritis Peripheral motor neuropathy Peripheral neuritis Psoriasis

Nivolumab and nivolumab/hyaluronidase-nvhy can cause fetal harm if administered to pregnant women based on nivolumab's mechanism of action and animal findings. The effects of nivolumab and nivolumab/hyaluronidase-nvhy may be greater during the second and third trimesters of pregnancy. Verify pregnancy status in females of reproductive potential prior to initiating treatment with nivolumab or nivolumab/hyaluronidase-nvhy.

It is not known whether nivolumab or hyaluronidase is distributed into human milk; the effects on the breast-fed child and on milk production are also not known. Because of the potential for serious adverse reactions in the breast-fed child, women should be advised not to breast-feed during treatment with nivolumab or nivolumab/hyaluronidase-nvhy and for 5 months after the last dose.

Some clinical studies of nivolumab (Opdivo(R)) monotherapy in patients with cHL, squamous cell carcinoma of the head and neck, and MSI-H or dMMR metastatic colorectal cancer did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger adults; however, no clinically important differences in safety or efficacy were observed between patients >=65 years of age and younger adults in other clinical studies in patients with melanoma, NSCLC, renal cell carcinoma, urothelial carcinoma, esophageal squamous cell carcinoma, and esophageal or gastroesophageal junction cancer. In clinical trials evaluating monotherapy with nivolumab/hyaluronidase-nvhy (Opdivo Qvantig(R)), 48% of patients were >=65 years of age and 14% were >=75 years of age; no overall differences in safety or efficacy were observed between geriatric patients and younger adults. Trials of IV nivolumab (Opdivo(R)) in combination with ipilimumab for the following indications included geriatric patients: melanoma (>=65 years, 41%; >=75 years, 11%), NSCLC (>=65 years, 48%; >=75 years, 10%), malignant pleural mesothelioma (>=65 years, 77%; >=75 years, 26%), advanced renal cell carcinoma (>=65 years, 38%; >=75 years, 8%), and esophageal squamous cell carcinoma (ESCC; >=65 years, 43%; >=75 years, 7%).

No overall differences in safety and efficacy were observed between geriatric patients and younger adults. However, patients >=75 years of age experienced higher rates of serious adverse reactions and/or discontinuation due to adverse reactions compared to all patients who received combination therapy in trials of patients with NSCLC (29 versus 18%, respectively), malignant pleural mesothelioma (54 versus 28%, respectively), and ESCC (38 versus 23%, respectively). Clinical studies of patients with hepatocellular carcinoma treated with nivolumab plus ipilimumab did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently from younger adults.

Trials of IV nivolumab (Opdivo(R)) in combination with platinum-containing chemotherapy for the following indications included geriatric patients: NSCLC (combination therapy (>=65 years, 48%; >=75 years, 6%); combination therapy followed by nivolumab monotherapy (>=65 years, 56%; >=75 years, 7%)), ESCC, gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma (>=65 years, 42%; >=75 years, 10%), and urothelial carcinoma (>=65 years, 40%; >=75 years, 11%). No overall differences in safety and efficacy were observed between geriatric patients and younger adults. In trials of IV nivolumab (Opdivo(R)) in combination with ipilimumab and platinum doublet chemotherapy for the treatment of NSCLC, 51% of patients were >=65 years of age and 10% were >=75 years of age.

No overall differences in safety and efficacy were observed between geriatric patients and younger adults; however, patients >=75 years of age experienced higher rates of discontinuation due to adverse reactions compared to all patients who received combination therapy (43 versus 24%, respectively). In trials of IV nivolumab (Opdivo(R)) in combination with cabozantinib for the treatment of renal cell carcinoma, 41% of patients were >=65 years of age and 9% were >=75 years of age. No overall differences in safety and efficacy were observed between geriatric patients and younger adults.