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U.S. Department of Health and Human Services

Safety

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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

 

June 2012

Summary View

 

CONTRAINDICATIONS

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.
 

DRUG INTERACTIONS

Anti-HIV Drugs
  • 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

 

September 2010

Summary View

 

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.

 

ADVERSE REACTIONS

Clinical Trials Experience
  • Cardiac disorders: Torsades de pointes

 

DRUG INTERACTIONS

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…