FDA Approves Merck's New Formulation For Noxafil Injection
Merck announced that the U.S. Food and Drug Administration (FDA) have approved its new formulation of NOXAFIL (posaconazole) injection (18 mg/ mL) for intravenous (IV) use.
Noxafil is an antifungal agent indicated for the prevention of invasive Aspergillus and similar aggressive fungal infections in high-risk patients who are immunocompromised. These include hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or patients with hematologic malignancies with prolonged neutropenia (low white blood cell counts) due to chemotherapy. The drug’s injection formulation is indicated in patients 18 years old and above. Posaconazole is counter indicated in patients who are allergic to the drug or other azole antifungal drugs.
Dr. Nicholas Kartsonis, executive director of the Infectious Disease at Merck Research Laboratories, said “Merck is pleased 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. In addition, patients have the possibility to start on NOXAFIL injection and transition to oral NOXAFIL.”
The new injection formulation provides patients with once-daily maintenance dosing after a twice-daily loading dose on the first day of the treatment. The drug should be administered with a loading dose of 300 mg twice a day on the first day of therapy, then 300 mg once a day from that time on. Co-administration of drugs that decrease posaconazole’s plasma concentration should be avoided in general unless potential benefits justify the risk. Close observation for breakthrough fungal infections is needed in such cases.
In addition to the newly approved indication, Noxafil is also marketed in delayed-release tablets (100 mg) and oral suspension (40 mg/mL). Merck said it expects Noxafil injection to be available at wholesale drug stores in mid-April.