Professional Resources
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Please click on the title of any of the following journal articles you would like to view.
Antifungal Prophylaxis
Posaconazole vs. Fluconazole or Itraconazole Prophylaxis in Patients with Neutropenia. (Cornely OA, et al. N Engl J Med. 2007;356:348-359.)
A randomized, open-label, evaluator-blinded, active-controlled, parallel-group, multicenter trial, comparing the efficacy and safety of posaconazole with fluconazole or itraconazole for the prevention of IFIs in patients at high risk due to anticipated neutropenia (N=602).
Posaconazole or Fluconazole for Prophylaxis in Severe Graft-versus-Host Disease.
(Ullmann AJ, et al. N Engl J Med. 2007;356:335-347.)
A randomized, double-blind, double-dummy, parallel-group, multicenter trial comparing the efficacy and safety of posaconazole with fluconazole in the prevention of IFIs in allogeneic HSCT patients with GVHD who were receiving intensive immunosuppressive therapy (N=600).
OPC/rOPC
A Multicenter Randomized Trial Evaluating Posaconazole versus Fluconazole for the Treatment of Oropharyngeal Candidiasis in Subjects with HIV/AIDS. (Vazquez JA, et al. Clin Infect Dis. 2006;42:1179-1186.)
A multicenter, randomized, evaluator-blinded clinical study comparing the efficacy, tolerability, and safety of posaconazole with those of fluconazole for the treatment of OPC in patients infected with HIV (N=350).
Posaconazole for the Treatment of Azole-Refractory Oropharyngeal and Esophageal Candidiasis in Subjects with HIV Infection. (Skiest DJ, et al. Clin Infect Dis. 2007;44:607-614.)
A multicenter, international, Phase III, open-label study to evaluate the efficacy and safety of posaconazole for HIV-infected subjects with oropharyngeal candidiasis (OPC) and/or esophageal candidiasis (EC) who were unresponsive to standard treatment with oral fluconazole or itraconazole (N=199).
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Important Safety Information
NOXAFIL® has been shown to interact with several medications, including drugs that suppress the immune system, and these reactions may be serious. The product label should be consulted when other drugs are prescribed with NOXAFIL®.
Coadministration with sirolimus or ergot alkaloids is contraindicated. Coadministration with the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, halofantrine, or quinidine, is also contraindicated since this may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes.
Serious and rare fatal toxicity from cyclosporine has occurred when taken in combination with NOXAFIL® and therefore reduction of the dose of drugs like cyclosporine or tacrolimus and frequent monitoring of drug levels of these medications are necessary when taking them in combination with NOXAFIL®.
In clinical trials, there were infrequent cases of hepatic reactions (eg, mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin, and/or clinical hepatitis). Rarely, more severe hepatic reactions including cholestasis or hepatic failure including fatalities were reported in patients with serious underlying medical conditions (eg, hematologic malignancies) during treatment with posaconazole. Liver function tests should be monitored at the start of and during the course of therapy. Discontinuation of NOXAFIL® must be considered in patients who experience symptoms consistent with liver disease that may be attributable to NOXAFIL®.
The safety and effectiveness of NOXAFIL® in patients below the age of 13 years old have not been established.
The most common treatment-related serious adverse events (1% each) in the combined prophylaxis studies were bilirubinemia, increased hepatic enzymes, hepatocellular damage, nausea, and vomiting.
In the pooled prophylaxis safety analysis, fever, headache, anemia, diarrhea, nausea, vomiting, abdominal pain, hypokalemia, and thrombocytopenia were frequently reported treatment-emergent adverse events.
In clinical studies of OPC and refractory OPC, adverse events were reported more frequently in the pool of patients with refractory OPC. The most commonly reported serious adverse events in refractory OPC patients included fever (13%) and neutropenia (10%).
