The US Food and Drug Administration has approved Merck’s antifungal agent NOXAFIL (posaconazole) injection (18mg/ mL), a new formulation for intravenous (IV) use.
The antifungal agent is also marketed as NOXAFIL (100mg) delayed-release tablets and NOXAFIL (40 mg/mL) oral suspension.
NOXAFIL injection, delayed-release tablets and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections.
It is indicated for patients who are at high-risk of developing these infections due to being severely immunocompromised such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
NOXAFIL injection is indicated in patients 18 years and older, while the delayed-release tablets and oral suspension are indicated in patients 13 years and above.
The approval helps Merck provide an IV formulation and two oral formulations of NOXAFIL for prophylaxis against invasive Aspergillus and Candida infections in high-risk patients.
According to the company, NOXAFIL should not be given to people allergic to posaconazole or other azole antifungal medicines and should not be administered with sirolimus, pimozide, quinidine, atorvastatin, lovastatin, simvastatin and ergot alkaloids.
Merck Research Laboratories executive director of infectious disease Nicholas Kartsonis said: "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."
NOXAFIL injection is given with a loading dose of 300mg (one 300mg vial) twice a day on the first day of NOXAFIL therapy, then 300mg (one 300mg vial) once a day afterwards.
Once combined with a mixture of intravenous solution, NOXAFIL injection should be immediately administered through an in-line filter.
According to clinical trials, adverse reactions reported for NOXAFIL IV injection were generally similar in type to that reported in trials of NOXAFIL oral suspension.
Most frequently reported adverse reactions with an onset during the posaconazole intravenous phase of dosing 300mg once-daily therapy were diarrhea, hypokalemia, fever and nausea.
The company intends to make NOXAFIL injection available at wholesalers in mid-April.