Drug Interactions between rosuvastatin and Vivjoa

ADJUST DOSE: Coadministration with oteseconazole may increase the plasma concentrations of drugs that are substrates of the breast cancer resistance protein (BCRP) such as rosuvastatin. The proposed mechanism is decreased rosuvastatin clearance due to inhibition of BCRP-mediated intestinal and/or hepatic transport by oteseconazole. When coadministered with oteseconazole, rosuvastatin peak plasma concentration (Cmax) and systemic exposure (AUC 0-24h) increased by 118% and 114%, respectively. High levels of HMG-CoA reductase inhibitory activity in plasma is associated with an increased risk of musculoskeletal toxicity. Myopathy manifested as muscle pain and/or weakness associated with grossly elevated creatine kinase exceeding ten times the upper limit of normal has been reported occasionally. Rhabdomyolysis has also occurred rarely, which may be accompanied by acute renal failure secondary to myoglobinuria and may result in death.

MANAGEMENT: When concomitant use of oteseconazole is required, the lowest possible starting dosage or a reduction of the existing dosage of rosuvastatin should be considered. Patients should be advised to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Rosuvastatin should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed.