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Noxafil (posaconazole) Oral Suspension
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010 and June 2012
HMG-CoA Reductase Inhibitors Primarily Metabolized Through CYP3A4
- Coadministration with the HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 (e.g., atorvastatin, lovastatin, and simvastatin) is contraindicated since increased plasma concentration of these drugs can lead to rhabdomyolysis.
- Fosamprenavir: Combining fosamprenavir with posaconazole may lead to decreased posaconazole plasma concentrations. If concomitant administration is required, close monitoring for breakthrough fungal infections is recommended
WARNINGS AND PRECAUTIONS
Arythmias and QT Prolongation
- Some azoles, including posaconazole, have been associated with prolongation of the QT interval on the electrocardiogram. In addition, rare cases of torsades de pointes have been reported in patients taking posaconazole.
Clinical Trials Experience
- Cardiac disorders: Torsades de pointes
HMG-CoA reductase Inhibitors (Statins) Metabolized Through CYP3A4
- Concomitant administration of posaconazole with simvastatin increases the simvastatin plasma concentrations by approximately 10 fold. Therefore, posaconazole is contraindicated with HMG-CoA reductase inhibitor simvastatin.
- Although not studied clinically with statins other than simvastatin, posaconazole may increase the plasma concentrations of statins that are metabolized by CYP3A4. Increased plasma statin concentrations can be associated with rhabdomyolysis. It is recommended that patients be monitored for adverse events and dose reduction of the statin be considered during co-administration with posaconazole.
PATIENT PACKAGE INSERT
What should I tell my doctor before taking Noxafil?
- Have, or have had, an abnormal heart rate or rhythm.
- Serious and rare fatal toxicity from cyclosporine has occurred when taken in combination with posaconazole…