New antifungal approved for high-risk patients

October 23, 2006

Invasive fungal infections will have less of a fighting chance now that a new antifungal has been approved by the Food & Drug Administration. Posaconazole (Noxafil, Schering-Plough), available as an oral suspension, is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

Peggy L. Carver, Pharm.D., associate professor at the University of Michigan College of Pharmacy, believes the new drug will prove very useful in this setting. "We will likely use it since it's orally administered and quite effective with a broad spectrum of activity." She explained that up until now, she'd been using other antifungals, such as fluconazole, and, rarely, itraconazole (Sporanox, Sandoz), which is effective but poorly tolerated by patients. Micafungin (Mycamine, Astellas) is also approved for this indication but requires an IV-which can be a problem given the risk of infection in these patients and the long-term use of prophylaxis, she said.

"From a safety standpoint, clinicians should monitor a patient's hepatic function," pointed out Michael E. Klepser, Pharm.D., FCCP, professor of pharmacy, Ferris State University in Kalamazoo, Mich. In fact, according to the prescribing information, liver function tests (LFTs) should be evaluated at the start of and during the course of posaconazole therapy. Patients who develop abnormal LFTs during treatment should be monitored for the development of more severe hepatic injury. "In addition, the absorption of the drug can be highly variable and is best when large daily doses are divided and administered with food," Klepser added.

Pharmacokinetic studies have shown that the mean AUC and Cmax of posaconazole are substantially higher when the drug is taken with food than in the fasting state. Therefore, it is recommended to administer the drug with a full meal or a liquid nutritional supplement. Patients who cannot eat or tolerate a nutritional supplement should be monitored closely for breakthrough fungal infections.

Posaconazole oral suspension is a white, cherry-flavored, immediate-release suspension containing 40 mg posaconazole per ml and is available in four-oz. glass bottles.

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