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FDA approves IV formulation of Noxafil
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The FDA today approved posaconazole injection for prophylaxis of invasive Aspergillus and Candida infections, according to the agent’s manufacturer.
Posaconazole (Noxafil, Merck) injection — a new 18 mg/mL formulation of the antifungal agent for IV use — is expected to be available by mid-April. It is indicated for patients aged 18 years and older who are severely immunocompromised, such as those who develop graft-versus-host disease after hematopoietic stem cell transplantation or those with hematologic malignancies who experience prolonged neutropenia from chemotherapy.
Posaconazole also is marketed in 100-mg/mL delayed-release tablets, as well as in a 40-mg/mL oral suspension formulation. Those formulations are indicated for patients aged 13 years and older.
“Merck is pleased to add Noxafil injection to the Noxafil family of products,” Nicholas Kartsonis, MD, executive director of infectious disease at Merck Research Laboratories, said in a press release. “The availability of a Noxafil formulation for intravenous administration is particularly important for those patients who may benefit from or require intravenous therapy, or who, for a variety of reasons, might not be able to take an oral formulation. In addition, patients have the possibility to start on Noxafil injection and transition to oral Noxafil.”
Posaconazole injection is administered in a twice-daily 300-mg loading dose on the first day of therapy, followed by once-daily 300-mg maintenance doses.
Adverse reactions reported in clinical trials of posaconazole injection were similar to those reported in trials of the oral suspension formulation, according to Merck’s press release. The most frequent adverse events were diarrhea (32%), hypokalemia (22%), fever (21%) and nausea (19%).