Merck announced that the FDA has approved Noxafil (posaconazole) injection (18mg/mL), a new formulation of the antifungal agent Noxafil for intravenous (IV) use.

Noxafil is indicated for prophylaxis against invasive Aspergillus and Candida infections, in patients at high risk due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft vs. host disease (GVHD), or those with hematologic malignancies with prolonged neutropenia due to chemotherapy.

RELATED: Infectious Disease Resource Center

Posaconazole is an antifungal that blocks the synthesis of ergosterol through the inhibition of lanosterol 14α-demethylase, an enzyme that is responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane. This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane thus weakening the structure and function of the fungal cell membrane.

Noxafil injection is indicated in patients ≥18 years of age and is also marketed as Noxafil (100mg) delayed-release tablets and Noxafil (40mg/mL) oral suspension. The delayed-release tablets and oral suspension are indicated in patients ≥13 years of age.

Noxafil injection is expected to be available in mid-April.

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