Sonidegib and Food

Sonidegib should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal. The presence of food can significantly increase the absorption of sonidegib into the blood stream. This may increase side effects such as muscle spasms, muscle pain, muscle weakness, fatigue, nausea, vomiting, diarrhea, loss of appetite, weight loss, hair loss, itching, and taste abnormalities. You may also have an increased risk of developing a rare but serious condition called rhabdomyolysis that involves the breakdown of skeletal muscle tissue. In some cases, rhabdomyolysis can cause kidney damage and even death. Let your doctor know immediately if you have unexplained muscle pain, tenderness, or weakness during treatment with sonidegib, especially if these symptoms are accompanied by fever or dark colored urine. Grapefruit juice may also increase the blood levels of sonidegib and should be avoided. Talk to your doctor or pharmacist if you have any questions or concerns.

ADJUST DOSING INTERVAL: Food significantly increases the oral bioavailability of sonidegib. According to the product labeling, administration of sonidegib with a high-fat meal (approximately 1000 calories; 50% from fat) increased mean sonidegib peak plasma concentration (Cmax) and systemic exposure (AUC) by 7.4- to 7.8-fold.

GENERALLY AVOID: Grapefruit juice may increase the plasma concentrations of sonidegib. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Increased exposure to sonidegib may increase the risk of adverse effects such as musculoskeletal toxicity, fatigue, nausea, vomiting, diarrhea, anorexia, weight loss, alopecia, pruritus, and dysgeusia.

MANAGEMENT: Sonidegib should be administered on an empty stomach, at least 1 hour before or 2 hours after a meal. Patients should avoid consumption of grapefruit or grapefruit juice during treatment with sonidegib.