Informational only — Not medical advice. Always consult a licensed healthcare provider.

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Indications

Cancer

Nivolumab is an antibody that blocks the programmed death receptor-1 (PD-1). It is used as a single agent for patients with BRAF V600 wild-type unresectable or metastatic melanoma, and also for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Nivamo is likewise a PD-1 blocking antibody, and it is indicated for the same two groups of melanoma patients as a single agent. It is also given to patients with unresectable or metastatic melanoma in combination with ipilimumab. Another use is in the adjuvant setting, for patients with melanoma who have lymph node involvement or metastatic disease and have had a complete resection. In metastatic non-small cell lung cancer, it is for patients whose disease has progressed on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should first have disease progression on FDA-approved therapy for these aberrations before they receive nivolumab. For advanced renal cell carcinoma, it is used in patients who have already had antiangiogenic therapy. It is also used with ipilimumab in patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma. In adults with classical Hodgkin lymphoma, it is for disease that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or after three or more lines of systemic therapy that includes autologous HSCT. It is used in recurrent or metastatic squamous cell carcinoma of the head and neck, when the disease has progressed on or after a platinum-based therapy. For locally advanced or metastatic urothelial carcinoma, it is used in patients whose disease has progressed during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. In adults and children aged 12 years and older, it is used for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Last, it is used in patients with hepatocellular carcinoma who have been previously treated with sorafenib.

⚠️ Always consult a registered physician before taking any medicine.

Pharmacology

Nivolumab works on the PD-1 pathway. When the ligands PD-L1 and PD-L2 bind to the PD-1 receptor on T cells, T-cell proliferation and cytokine production are inhibited. Some tumors upregulate these PD-1 ligands, and signaling through this pathway can contribute to blocking the active immune surveillance of tumors by T cells.

Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody. It binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2. This releases the inhibition of the immune response that the PD-1 pathway causes, and that includes the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity decreased tumor growth.

When nivolumab (anti-PD-1) is combined with ipilimumab (anti-CTLA-4), the inhibition of both targets improves T-cell function more than either antibody does alone. This gives better anti-tumor responses in metastatic melanoma and advanced RCC. In murine syngeneic tumor models, dual blockade of PD-1 and CTLA-4 also increased anti-tumor activity.

Pregnancy & Breastfeeding

Pregnancy: Nivolumab can harm the unborn baby when a pregnant woman is given it. This is based on how the medicine works and on animal studies. The effects are likely to be greater in the second and third trimesters. There are no human data on the risk, so pregnant women should be told about the possible risk to the baby.

Lactation: No one knows whether Nivolumab passes into human milk. Many drugs, including antibodies, do pass into breast milk, and Nivolumab could cause serious adverse reactions in a nursing infant. For this reason, women should stop breastfeeding during treatment with Nivolumab.

Contraception: Because of how Nivolumab works, it can harm the baby if given to a pregnant woman. Women who could become pregnant should use effective contraception during treatment and for at least 5 months after the last dose of Nivolumab.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Dosage Reference

⚠️ Reference ranges from official sources only. Consult your doctor for personalized dosing.

Adults: The recommended dosage of Nivolumab for unresectable or metastatic melanoma, when used as a single agent, is either 240 mg every 2 weeks or 480 mg every 4 weeks. It is given as an intravenous infusion over 30 minutes, and treatment continues until the disease progresses or toxicity becomes unacceptable. When Nivolumab is combined with ipilimumab, the dose is 1 mg/kg as an intravenous infusion over 30 minutes. Ipilimumab 3 mg/kg follows on the same day as an intravenous infusion over 90 minutes. This is repeated every 3 weeks for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier. After the 4 doses of the combination, Nivolumab is given alone, either 240 mg every 2 weeks or 480 mg every 4 weeks, as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. In adjuvant treatment of melanoma, the dosage is either 240 mg every 2 weeks or 480 mg every 4 weeks as an intravenous infusion over 30 minutes, continued until disease recurrence or unacceptable toxicity, for up to 1 year. In NSCLC, the recommended dosage is either 240 mg every 2 weeks or 480 mg every 4 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. As a single agent in RCC, the recommended dose is either 240 mg every 2 weeks or 480 mg every 4 weeks, given as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. The cHL dosage is either 240 mg every 2 weeks or 480 mg every 4 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. SCCHN uses the same two options, 240 mg every 2 weeks or 480 mg every 4 weeks, as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. Urothelial carcinoma is also treated with either 240 mg every 2 weeks or 480 mg every 4 weeks as an intravenous infusion over 30 minutes, until disease progression or unacceptable toxicity. In CRC, the recommended dose is 240 mg every 2 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. HCC patients receive either 240 mg every 2 weeks or 480 mg every 4 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.