OPC
Effective treatment of oropharyngeal candidiasis (OPC)25
- Mycologic eradication (absence of CFU) at Day 14:
- 52% (88/169) with NOXAFIL® vs 50% (80/160) with fluconazole
- Mycologic relapse at 4 weeks after end of treatment:
- 56% (49/88) with NOXAFIL® vs 64% (51/80) with fluconazole
- Mycologic response‡:
- 68% with NOXAFIL® vs 68% with fluconazole
- Adverse events with NOXAFIL® were comparable to fluconazole in the pooled safety analysis
Study description25
- Randomized, controlled, evaluator-blinded study in HIV-infected patients with OPC
- Patients were treated with NOXAFIL® or fluconazole oral suspension
- Loading dose of both study medications was 100 mg BID for 1 day, followed by 100 mg QD for 13 days
- Clinical and mycologic outcomes were assessed:
- After 14 days of treatment (primary endpoint)
- At 4 weeks after the end of treatment
- Safety was evaluated in two randomized, comparative studies in OPC (NOXAFIL® ≤400 mg QD vs fluconazole 100 mg QD)
* Clinical success defined as complete or partial resolution of all ulcers and/or plaques and symptoms.
† Clinical relapse defined as recurrence of signs or symptoms after initial cure or improvement.
‡ Mycologic response/success defined as a post-treatment quantitative culture with ≤20 colony forming units (CFU)/mL. The clinical significance of this finding is unknown.
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%).
