Colorectal cancer, metastatic:
1. As a ingle agent or combined with Ipilimumab
2. Treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) in adults and pediatric patients 12 years and older that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Head and neck cancer, squamous cell:
Treatment of recurrent or metastatic squamous cell carcinoma of the head and neck in patients with disease progression on or after platinum-based therapy.
Hodgkin lymphoma, classical:
Treatment of classical Hodgkin lymphoma (cHL) in adult patients that have relapsed or progressed following autologous hematopoietic stem cell transplant (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT.
Melanoma, unresectable or metastatic:
1. As a ingle agent or combined with Ipilimumab.
2. Treatment of BRAF V600 wild-type or BRAF V600 mutation-positive unresectable or metastatic melanoma.
Non-small cell lung cancer:
1. Treatment of metastatic NSCLC that has progressed on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression (on approved EGFR- or ALK-directed therapy) prior to receiving nivolumab.
2. With Ipilimumab: First line treatment in adults whose tumors express PD-L1 ((1%) as determined by an approved test, and with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
3. With Ipilimumab and 2 cycles of platinum doublet chemotherapy: First line treatment in adults with no EGFR or ALK genomic tumor aberrations.
Gastric cancer and gastroesophageal junction cancer:
1. In combination with fluoropyrimidine- and platinum-containing chemotherapy. 2. Treatment of advanced or metastatic gastric cancer and gastroesophageal junction cancer.
Hepatocellular carcinoma:
1. As a single agent or combined with Ipilimumab.
2. Treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib.
Esophageal carcinoma, squamous cell:
Treatment of unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.

Antineoplastic Agent, Anti-PD-1 Monoclonal Antibody
Nivolumab is a monoclonal antibody that enhances the antitumor response by binding to PD-1 receptors and blocking its interaction with PD-L1 and PD-L2.

1.Distribution: Vdss: 6.8 L; the predicted exposure after a 30-minute infusion is comparable to that seen with a 60-minute infusion.
2.Half-life elimination: ~25 days.
3.Excretion: Clearance (geometric mean at steady state): 8.2 mL/hour.

Hypersensitivity to nivolumab or any component of the formulation.

Fetal risk may occur when used during pregnancy. Evidence from animal data and/or the mechanism of action of the drug supports risk.

It is not known if nivolumab is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends to discontinue breastfeeding during treatment and for 5 months after the last nivolumab dose.

Dermatologic: Pruritus, Rash
Endocrine metabolic: Hyperglycemia, Hyperkalemia, Hypocalcemia, Hyponatremia, cholesterol or triglycerides raised
Gastrointestinal: Constipation, Decrease in appetite, Nausea, Vomiting
Hematologic: Anemia, Lymphocytopenia
Hepatic: Alkaline phosphatase raised, ALT/SGPT level raised or AST/SGOT level raised
Musculoskeletal: Arthralgia, Backache, Musculoskeletal pain
Neurologic: Asthenia, Headache, Peripheral neuropathy
Renal: Serum creatinine raised
Respiratory: Cough, Dyspnea
Other: Fatigue

Melanoma, unresectable or metastatic:
Single-agent therapy:
IV: 240 mg once every 2 weeks or 480 mg once every 4 weeks; continue until disease progression or unacceptable toxicity.
Combination therapy:
IV: 1 mg/kg once every 3 weeks (in combination with ipilimumab) for a maximum of 4 combination doses or until unacceptable toxicity (whichever occurs earlier), followed by nivolumab (as a single agent) 240 mg once every 2 weeks or 480 mg once every 4 weeks; continue until disease progression or unacceptable toxicity.
Non–small cell lung cancer:
Metastatic, with PD-L1 expression ((1%):
IV: 360 mg once every 3 weeks (in combination with ipilimumab); continue until disease progression, unacceptable toxicity or for up to 2 years in patients without disease progression.
Metastatic or recurrent: IV:
360 mg once every 3 weeks (in combination with ipilimumab and 2 cycles of histology-based platinum-doublet chemotherapy); continue until disease progression, unacceptable toxicity or for up to 2 years in patients without disease progression.
Head and neck cancer, squamous cell carcinoma:
IV: 240 mg once every 2 weeks or 480 mg once every 4 weeks; continue until disease progression or unacceptable toxicity.
Hodgkin lymphoma, classical:
IV: 240 mg once every 2 weeks or 480 mg once every 4 weeks; continue until disease progression or unacceptable toxicity.
Gastric cancer or gastroesophageal junction cancer, advanced or metastatic:
IV: 240 mg once every 2 weeks or 360 mg once every 3 weeks, in combination with fluoropyrimidine- and platinum-containing chemotherapy; continue until disease progression, unacceptable toxicity, or up to 2 years.
Esophageal cancer, squamous cell carcinoma:IV:
240 mg once every 2 weeks (Doki 2022) or 480 mg once every 4 weeks, in combination with fluoropyrimidine- and platinum-containing chemotherapy.

1.Mild (total bilirubin ULN and AST > ULN or total bilirubin >1 to 1.5 × ULN and any AST) or moderate (total bilirubin >1.5 to 3 × ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, mild or moderate impairment had no clinically important effect on nivolumab clearance.
2.Severe (total bilirubin >3 × ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer's labeling .