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Pharmaceutical approval update.

CYP3A inhibitors. When ivacaftor is co-administered with a strong CYP3A inhibitor (e.g., ketoconazole), the dose should be reduced to 150 mg twice weekly. When ivacaftor is coadministered with a moderate CYP3A inhibitor (e.g., fluconazole), the dose should be reduced to 150 mg once daily. Grapefruit products and Seville oranges should be avoided. Renal impairment. Ivacaftor has not been studied in patients with renal impairment. For individuals with mild-tomoderate impairment, no dosage adjustments are required. Caution is advised if impairment is severe (a creatinine clearance below 30 mL/minute) or if the patient has end-stage renal disease. Hepatic impairment. For patients with hepatic mild impairment (Child–Pugh Class A), no dosage adjustments are required. For moderate (Child–Pugh Class B) impairment, the dose should be reduced to 150 mg once daily. The dosage for patients with severe impairment (Child–Pugh Class C) has not been studied, but ivacaftor levels can be expected to be higher. Ivacaftor should be used with caution at a reduced dose of 150 mg once daily or less frequently. Commentary: CF is the most common fatal genetic disease in Caucasians, with a prevalence of approximately 30,000 persons in the U.S. Of these individuals, approximately 4% (1,200 patients) have the G551D mutation. CF affects the lungs and other organs and almost always leads to an early death. It is caused by mutations in a gene that encodes for a protein, called CFTR, that regulates chloride and water transport in the body. This defect in transport results in the formation of thick mucus that builds up in the lungs, digestive tract, and other parts of the body, leading to severe respiratory and digestive problems and other complications such as infections and diabetes. Pulmonary exacerbations are the leading cause of hospitalizations for patients with CF and account for 50% of the annual medical costs associated with the disease. Ivacaftor is effective only in patients with CF who have the G551D mutation. If a patient’s mutation status is not known, a genetic test for CF should be conducted to determine whether the G551D mutation is present. Sources: http://drugtopics.modernmedicine.com; http:// reference.medscape.com/drug/kalydeco-ivacaftor-999719