Neratinib extends adjuvant treatment of patients with HER2-positive breast cancer

Warnings and precautions

Neratinib is marketed as Nerlynx by Puma Biotechnology Inc. The prescribing information describes warnings and precautions relating to diarrhea, hepatotoxicity, and embryofetal toxicity. Patients should be monitored for diarrhea and treated with antidiarrheals as needed. Severe diarrhea with dehydration should be treated with fluids and electrolytes as needed, treatment should be interrupted and resumed at a reduced dose. For grade 3/4 diarrhea or diarrhea with complicating features (eg, dehydration, fever, neutropenia), stool cultures should be performed to rule out infectious causes.

Total bilirubin, aspartate and alanine aminotransferase, and alkaline phosphatase levels should be measured before starting treatment, every 3 months during treatment, or as clinically indicated. Neratinib can cause fetal harm, so pregnant women should be advised of the risk to the fetus and patients of reproductive potential should be counseled on the need for effective contraception during treatment and for at least 1 month after the last dose.⁴