Opdivo

Generic name:

Nivolumab

Drug class:

Programmed death-1 (PD-1) immune checkpoint inhibitor (monoclonal antibody)

Dosage form:

• Concentrate for intravenous infusion: 10 mg/mL in 40 mg/4 mL and 100 mg/10 mL vials
• Prefilled solution for infusion: 240 mg/8 mL and 480 mg/16 mL

Route of administration:

Intravenous infusion

Dose:

Varies by indication; consult label.

• 3 mg/kg every 2 weeks
• 240 mg every 2 weeks
• 480 mg every 4 weeks
• Combination with ipilimumab: 1 mg/kg nivolumab + 3 mg/kg ipilimumab every 3 weeks for 4 doses, then maintenance nivolumab

Mechanism of action:

Nivolumab is a fully human IgG4 monoclonal antibody that binds to PD-1 receptors on activated T cells, blocking interaction with PD-L1/PD-L2 ligands and restoring anti-tumor T-cell activity.

Drug usage cases:

• Unresectable or metastatic melanoma
• Adjuvant treatment of melanoma with lymph node involvement
• Non–small cell lung cancer (NSCLC), metastatic or recurrent
• NSCLC, adjuvant therapy following resection and chemotherapy
• Renal cell carcinoma, advanced
• Classical Hodgkin lymphoma, relapsed or refractory
• Head and neck squamous cell carcinoma, recurrent or metastatic
• Urothelial carcinoma, locally advanced or metastatic
• Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer
• Hepatocellular carcinoma, previously treated
• Esophageal or gastroesophageal junction carcinoma, advanced
• Gastric cancer, advanced
• Endometrial carcinoma, MSI-H or dMMR
• Biliary tract carcinoma, advanced
• Cervical cancer, recurrent or metastatic
• Off-label: Varies by indication; consult treatment guidelines

Drug contraindications:

• History of severe hypersensitivity to nivolumab or any excipient

Side effects:

• Immune-mediated pneumonitis
• Immune-mediated colitis
• Immune-mediated hepatitis
• Immune-mediated nephritis and renal dysfunction
• Immune-mediated endocrinopathies (hypophysitis, thyroid disorders, adrenal insufficiency)
• Dermatologic reactions (rash, pruritus)
• Infusion-related reactions
• Fatigue
• Diarrhea
• Nausea and vomiting
• Decreased appetite
• Cough and dyspnea
• Musculoskeletal pain (arthralgia, myalgia)
• Fever
• Headache
• Electrolyte abnormalities (hypocalcemia, hyponatremia)

Warnings:

• Immune-mediated adverse reactions can be severe or fatal; monitor and manage promptly with corticosteroids
• Hold or discontinue for Grade 2 or greater immune-mediated events per guidelines
• Infusion-related reactions: monitor during and after infusion; manage with supportive care or corticosteroids
• Embryo-fetal toxicity: advise effective contraception during and for 5 months after treatment
• Avoid live vaccines during and after therapy until immune recovery
• Caution in patients with preexisting autoimmune disorders
• Monitor liver, renal, thyroid, adrenal function, and glycemic control

Use during pregnancy or breastfeeding:

Nivolumab can cause fetal harm. Pregnancy testing is recommended prior to initiation. Women of childbearing potential should use effective contraception during therapy and for at least 5 months after the last dose. It is unknown if nivolumab is excreted in human milk; due to potential for serious adverse reactions in nursing infants, discontinue breastfeeding during treatment and for 5 months after the last dose.