The Food and Drug Administration has approved atezolizumab (Tecentriq), a programmed death ligand 1-blocking monoclonal antibody, to treat patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. For this new indication, atezolizumab should be used in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf). After a 28-day cycle of cobimetinib and vemurafenib, atezolizumab is given intravenously every two weeks with cobimetinib given orally once daily (21 days on /seven days off) and vemurafenib given orally twice daily. Previously, atezolizumab was approved for use in treating urothelial carcinoma, non-small cell lung cancer, triple-negative breast cancer, small cell lung cancer, and hepatocellular carcinoma.

Efficacy was established in a randomized, double-blind, placebo-controlled, multicenter trial of 514 patients. After a 28-day cycle of cobimetinib and vemurafenib, patients received an infusion of either atezolizumab or placebo and continued treatment with oral cobimetinib and vemurafenib. Progression-free survival was significantly longer for those receiving atezolizumab compared with those receiving placebo (15.1 months versus 10.6 months).

The most common adverse effects of atezolizumab in combination with cobimetinib and vemurafenib are rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity. As already noted on the product's label, atezolizumab carries the following warnings and precautions: immune-mediated pneumonitis, immune-mediated hepatitis, immune-mediated colitis, immune-mediated endocrinopathies, infections, infusion-related reactions, and embryo-fetal toxicity.

Nurses who administer atezolizumab should remember that it does not contain preservatives, so it should be used immediately after reconstitution. It can be at room temperature for no longer than six hours after reconstitution, including the infusion time. If refrigerated, it must be kept between 2[degrees]C and 8[degrees]C (36[degrees]F and 46[degrees]F) for no more than 24 hours from time of reconstitution. It should not be frozen or shaken. The first infusion should be given over 60 minutes; if tolerated, subsequent infusions can be given over 30 minutes. Atezolizumab requires a dedicated IV line. It should never be administered as an IV push or bolus.

Nurses should provide information about the potential adverse effects of atezolizumab, including those listed in the warnings and precautions section of the label. Women of reproductive age should be taught to use effective contraception during treatment and for at least five months after the last atezolizumab dose because of the potential for embryo-fetal toxicity.

For full prescribing information for atezolizumab, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s028lbl.pdf.