Ibrance and Food

Palbociclib should be taken with food to help with its absorption. Do not consume grapefruit or grapefruit juice during treatment with palbociclib unless directed otherwise by your doctor. Grapefruit juice can increase the blood levels of palbociclib. You may be more likely to experience side effects such as nausea; vomiting; diarrhea; loss of appetite; mouth sores; hair loss; weakness; pain, numbness, or tingling in the hands and feet; and impaired bone marrow function resulting in low numbers of different types of blood cells, which can increase the risk of anemia, bleeding problems, and infections. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

ADJUST DOSING INTERVAL: Administration with food may enhance the oral bioavailability of palbociclib in some patients and reduce the intersubject variability of palbociclib exposure. According to the product labeling, palbociclib absorption and exposure were very low in approximately 13% of the population when taken in the fasted state. Food intake increased the palbociclib exposure in this small subset of the population, but did not alter palbociclib exposure in the rest of the population to a clinically relevant extent. Compared to palbociclib given under overnight fasted conditions, the population average palbociclib peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 38% and 21%, respectively, when given with high-fat, high-calorie food (approximately 800 to 1000 calories; 150, 250, and 500 to 600 calories from protein, carbohydrate and fat, respectively); by 27% and 12%, respectively, when given with low-fat, low-calorie food (approximately 400 to 500 calories; 120, 250, and 28 to 35 calories from protein, carbohydrate and fat, respectively); and by 24% and 13%, respectively, when given with moderate-fat, standard calorie food (approximately 500 to 700 calories; 75 to 105, 250 to 350 and 175 to 245 calories from protein, carbohydrate and fat, respectively) one hour before and two hours after palbociclib dosing.

GENERALLY AVOID: Grapefruit juice may increase the systemic exposure to palbociclib. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. Increased exposure to palbociclib may increase the risk of adverse effects such as infections, neutropenia, leukopenia, anemia, thrombocytopenia, anorexia, nausea, vomiting, diarrhea, stomatitis, alopecia, asthenia, peripheral neuropathy, and epistaxis.

MANAGEMENT: Patients should take palbociclib with food and avoid consumption of grapefruit or grapefruit juice during treatment.