Kisqali Femara Co-Pack and Alcohol/Food Interactions

Consumer information for this interaction is not currently available.

GENERALLY AVOID: Pomegranates and grapefruit may increase the systemic exposure to ribociclib. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in these fruits. Increased exposure to ribociclib may increase the risk of adverse effects such as infections, neutropenia, leukopenia, anemia, thrombocytopenia, anorexia, nausea, vomiting, diarrhea, stomatitis, alopecia, fatigue, headache, and abnormal liver function may be increased.

MANAGEMENT: Patients receiving ribociclib should avoid consumption of pomegranates or pomegranate juice and grapefruit or grapefruit juice during treatment.

letrozole - cholesterol

In an adjuvant clinical trial hypercholesterolemia was reported in 52.3% of letrozole patients and 28.6% of tamoxifen patients. CTC grade 3-4 hypercholesterolemia was reported in 0.4% of letrozole patients and 0.1% of tamoxifen patients. Also in the adjuvant setting, an increase of >=1.5 X ULN in total cholesterol (generally non-fasting) was observed in patients on monotherapy who had baseline total serum cholesterol within the normal range (i.e., <=1.5 X ULN) in 151/1843 (8.2%) on letrozole vs 57/1840 (3.2%). Caution is recommended when prescribing letrozole to these patients. Consideration should be given to monitoring serum cholesterol.

ribociclib - QT prolongation

Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner. This drug should be avoided in patients who are at significant risk of developing torsade de pointes, including those with: congenital long QT syndrome; uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism; electrolyte abnormalities. ECG should be performed in all patients prior to initiation of treatment; ribociclib should be started only in patients with QTcF (QT corrected for heart rate using Fridericia's formula) values less than 450 milliseconds. ECG should be repeated at Day 14 of the first cycle, and as clinically indicated. Serum electrolytes (including potassium, calcium, phosphorous, and magnesium) should be monitored before the initiation of treatment, at the beginning of the first 6 cycles, and as clinically indicated; any electrolyte abnormality should be corrected before starting this drug. Ribociclib may require dose interruption, dose reduction, or discontinuation according to observed QT prolongation during therapy.