Why Prophylaxis
A prophylactic agent with activity against Aspergillus and Candida* is needed
Invasive fungal infections (IFIs) occur in 5% to 25% of patients immunocompromised due to:
- Neutropenia10,15
- Allogeneic hematopoietic stem cell transplant (HSCT)8,10,18
- Immunosuppressant use23,30
IFIs, including aspergillosis, are difficult to diagnose and hard to treat
- In a recent study of patients with hematologic malignancies, 67% of IFIs were not diagnosed until autopsy3
- A successful outcome following primary treatment of invasive aspergillosis with voriconazole occurred in 51% of neutropenic patients and 32% of HSCT patients12
- Aspergillosis was responsible for 62% of all IFI-related deaths in patients with hematologic malignancies26
- There was 56% mortality in HSCT patients with aspergillosis34
Clinically significant mortality rates
- 50% to 80% mortality in neutropenic patients who develop an IFI14,37
- 80% 2-year mortality in HSCT patients who develop a non-Candida IFI18
Antifungal prophylactic options are limited9,11,20,22,31
*Aspergillus fumigatus and Candida albicans.
For additional information about the need for effective prophylaxis against both Aspergillus and Candida, click here http://www.whyprophylaxis.com.
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%).
