FDA Okays Antifungal Delayed-Release Tablets

Megan Brooks


November 26, 2013

The US Food and Drug Administration (FDA) has approved a new formulation of the triazole antifungal posaconazole (Noxafil, Merck), the manufacturer announced today.

The agency approved posaconazole 100-mg delayed-release tablets, given as a loading dose of 300 mg (three 100-mg delayed-release tablets) twice daily on the first day, followed by a once-daily maintenance dose of 300 mg (three 100-mg delayed-release tablets) on the second day of therapy.

Merck also markets posaconazole (also as Noxafil) in a 40 mg/mL oral suspension, which is dosed 3 times daily.

Posaconazole delayed-release tablets and oral suspension are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients aged 13 years and older who are at high risk of developing these infections because of being severely immunocompromised, such as hematopoietic stem cell transplant recipients who have graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

"Prophylaxis against invasive Aspergillus and Candida infections plays a key role in the management of severely immunocompromised patients with hematologic malignancies or hematopoietic stem cell transplant recipients who are at high risk for these life-threatening fungal infections," Daniel Couriel, MD, director of the Adult Blood and Marrow Transplantation Program at the University of Michigan Comprehensive Cancer Center in Ann Arbor, said in a company news release.

"Posaconazole delayed-release tablets offer physicians a way to help protect these critically ill patients against invasive Aspergillus and Candida infections while they are in the hospital and once they return home," he added.

The company reminds clinicians that posaconazole is contraindicated in persons allergic to posaconazole, any ingredients of Noxafil, or other azole antifungal agents. The administration of posaconazole with sirolimus, pimozide, quinidine, atorvastatin, lovastatin, simvastatin and ergot alkaloids "must be avoided."

When administered with posaconazole, some drugs such as cyclosporine and tacrolimus require dosage adjustments and frequent monitoring of blood levels, as serious adverse effects, including nephrotoxicity, leukoencephalopathy, and deaths, have been reported in patients with increased cyclosporine or tacrolimus blood levels, the company notes.

Posaconazole should be administered with caution in patients who may develop an irregular heart rhythm, as the drug has been shown to prolong the QT interval and cases of potentially fatal torsades de pointes have been reported in patients taking posaconazole, the company says.


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