Medication Monitor

Generic Name (Trade Name—Company)
April 10, 2019


New indication of palbociclib approved to treat men with metastatic breast cancer

FDA is extending the indication of palbociclib capsules in combination with specific endocrine therapies for hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced or metastatic breast cancer in male patients.

Palbociclib was initially approved in 2015 in combination with an aromatase inhibitor as the first hormonal-based therapy in women who have gone through menopause and in men, or with fulvestrant in patients whose disease progressed following hormonal therapy.

The most common adverse effects are infections, leukopenia  fatigue, nausea, stomatitis, anemia  hair loss, diarrhea, and thrombocytopenia. Other common adverse effects are rash, vomiting, decreased appetite, asthenia, and fever.

Health care providers are advised to monitor a patient’s blood count for neutropenia. Patients should have their blood count checked before starting palbociclib and at the beginning of each cycle, as well as on day 15 of the first two cycles and as clinically indicated.

Because of the potential for genotoxicity, health care providers are advised to tell male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose. Women who are pregnant or breastfeeding should not take palbociclib because it may cause harm to a developing fetus or newborn baby.