National and international guidelines recommend NOXAFIL® for prophylaxis against Aspergillus and Candida4,17,24,36*
| NCCN Guidelines24 | IDSA Guidelines36 | ECIL Guidelines17 | |
| AML/MDS (neutropenic) | NOXAFIL® The only Category 1 recommendation |
NOXAFIL® The only Category A-I recommendation for Aspergillus |
NOXAFIL® Category AI recommendation |
| HSCT with GVHD | NOXAFIL® The only Category 1 recommendation† |
NOXAFIL® The only Category A-I recommendation for Aspergillus |
NOXAFIL® Category AI recommendation |
Excerpted from:
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Prevention and Treatment of Cancer-Related Infections. V.1.2008. Available at: http://www.nccn.org/.
Walsh TJ, Anaissie EJ, Denning DW, et al. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008;46:327-360. Available at: http://www.idsociety.org/content.aspx?id=2656. Click on Aspergillus 2008 under the Fungi Category of Infections by Organism.
Maertens et al. 2007 update of the ECIL-1 guidelines for antifungal prophylaxis in leukemia patients, including allogeneic HSCT recipients [slide presentation]. Available at: http://www.eortc.be/.
- In the NCCN guidelines, a category 1 rating indicates there is uniform NCCN consensus, based on high-level evidence, that the recommendation is appropriate
- Voriconazole is given a category 2B recommendation, and no other azoles are recommended, for the patient groups listed above.
- In the IDSA guidelines, a category A-I rating indicates there is good evidence to support a recommendation for use and evidence from ≥1 properly randomized, controlled trial
- Itraconazole is given a category B-I recommendation, and no other antifungals are recommended, for the patient groups listed above
- In the ECIL guidelines, a category AI rating indicates strong evidence for efficacy and substantial clinical benefit based on evidence from at least one well-executed randomized trial
- Fluconazole is given a category AI recommendation for allogeneic HSCT patients and a category CI recommendation for patients receiving induction chemotherapy for acute leukemia. Itraconazole is given a category BI recommendation for allogeneic HSCT patients and a category CI recommendation for patients receiving induction chemotherapy for acute leukemia
* Aspergillus fumigatus and Candida albicans.
† Recommended in significant GVHD: Consider antifungal prophylaxis in all patients with GVHD receiving immunosuppressive therapy.
NCCN Clinical Practice Guidelines are a trademark of NCCN.
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%).
