FDA Approves Noxafil Treatment for Fungal Infections

A new breakthrough in treatment of fungal infections came this week as the FDA approved Noxafil (posaconazole) for the prevention of infections caused by certain molds and yeast-like fungus such as Aspergillus and Candida.

The FDA approved the antifungal drug for use in those patients with weakened immune systems (such as following a bone marrow transplant) and for those patients with decreased white blood cell counts (such as follows chemotherapy for cancer).

Healthy individuals are usually unaffected by these common fungi; but people with weak or abnormal immune systems are likely to become fatally ill when exposed to these pathogens.

Noxafil is an antifungal drug which contains an active substance never before approved in the U.S.

Safety and efficacy of Noxafil were tested in clinical trials of 1,844 patients ranging in age from 13-82 years.

Patients who received Noxafil had comparable or fewer rates of Aspergillus and Candida infections compared to those who received other antifungal medications.

The most common side effects of Noxafil were nausea, vomiting, rash, diarrhea, lowered potassium (K+) blood levels, lowered platelet counts, and abnormal results on tests of live function. For some people, Noxafil may have led to abnormal heart rhythm (prolongation of the QTc wave) and liver function impairement.

Noxafil should be taken with a full meal, and has been shown to interact severely with certain other medications.

Noxafil offers a new option for antifungal treatment following bone marrow transplant or chemotherapy.