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IV Posaconazole approved by the FDA

April 07 2014

First approved in 2006, posaconazole is the most broad spectrum antifungal available. Approval by the US Food and Drug Association of the intravenous formulation will allow many patients whose blood levels are low or predicted to be low with posaconazole solution, to be successfully treated.

The new IV formulation [NOXAFIL® (18mg/ml)] is indicated in adults is indicated for prophylaxis against invasive Aspergillus and Candida infections in high-risk patients, such as hematopoietic stem cell transplant recipients with GVHD, HIV patients or those with leukaemia.

In clinical bridging studies, the most frequently reported adverse reactions were diarrhoea (32%), hypokalemia (22%), fever (21%) and nausea (19%). The IV formulation will be beneficial to those patients who can't tolerate the oral posaconazole or those who may need IV administration for other reasons.  IV posaconazole is expected to be available from mid-April, almost the same time as the new posaconazole tablets.

Merck News report