Indications: Nivolumab (Opdivo) injection for intravenous use is a programmed death receptor-1 (PD-1) blocking antibody approved for treating patients with metastatic melanoma and metastatic squamous non-small–cell lung cancer.

Dosing: An intravenous infusion of 3 mg/kg over 60 minutes every 2 weeks. It comes in 40 mg/4 mL and 100 mg/10 mL strengths.

Pharmacokinetics: Nivolumab has a mean elimination half-life of 26.7 days, with steady-state concentrations reached after 12-weeks of administration every 2 weeks. Clearance of nivolumab is not affected by age, gender, race, baseline LDH, PD-L1 expression, tumor type, tumor size, renal impairment, and mild hepatic impairment.

More Information: Nivolumab was given accelerated approval for the treatment of unresectable or metastatic melanoma and disease progression following ipilimumab, and if BRAF V600 mutation positive, a BRAF inhibitor, based on tumor response rate and durability of response. Continued approval for this indication is contingent upon confirmatory trials.

Side Effects/Risks: The most common adverse reaction in patients with melanoma is rash. The most common adverse reactions in patients with advanced squamous non-small cell lung cancer are fatigue, dyspnea, musculoskeletal pain, decreased appetite, cough, nausea, and constipation.

Source: Highlights of prescribing information: Opdivo (nivolumab). U.S. Food & Drug Administration web site. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125527s000lbl.pdf. Revised March 2015. Accessed March 6, 2015.