Label Changes for:

Noxafil (posaconazole) oral suspension

September 2010

Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010

 

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…

 

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