Merck gets FDA approval for intravenous use of NOXAFIL injection

The antifungal agent is also marketed as NOXAFIL (100mg) delayed-release tablets and NOXAFIL (40 mg/mL) oral suspension.

The company said that NOXAFIL injection, delayed-release tablets and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections.

They are 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.

The injection is indicated in patients 18 years of age and older, while the NOXAFIL delayed-release tablets and oral suspension are indicated in patients 13 years of age and older.

With the approval, the company now provides an IV formulation and two oral formulations of NOXAFIL for prophylaxis against invasive Aspergillus and Candida infections in high-risk patients.

Merck Research Laboratories executive director of Infectious Disease Nicholas Kartsonis said the company is happy to add NOXAFIL injection to the NOXAFIL family of products.

"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," Kartsonis said.

"In addition, patients have the possibility to start on NOXAFIL injection and transition to oral NOXAFIL."

The 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 thereafter.

The company said that once combined with a mixture of intravenous solution, NOXAFIL injection should be immediately administered through an in-line filter.

According to the company, NOXAFIL injection will be available at wholesalers in mid-April 2014.