Friday, March 14, 2014
FDA Approves IV Formula of Supportive Drug Noxafil (Posaconazole)
The U.S. Food and Drug Administration has approved Noxafil (posaconazole) injection, a new formulation of the drug for intravenous use, for prophylaxis of invasive Aspergillus and Candida infections in patients at high risk of developing such infections due to being severely immunocompromised—which include patients who are hematopoietic stem cell transplant recipients with graft-versus-host disease or patients with hematologic malignancies with prolonged neutropenia from chemotherapy.
Noxafil injection is available in once-daily maintenance dosing (of 300 mg), following a twice-daily loading dose (300 mg each) on the first day of use. In clinical trials, the adverse reactions reported for the intravenous version of the drug were similar to those reported in the trials of the oral version of the drug, with the most frequently reported adverse reactions being diarrhea, hypokalemia, fever, and nausea.
The drug is marketed by Merck and is expected to be available mid-April, according to a news release from the company.