Basic Information
NOXAFIL ORAL SUSPENSION 40 mg/ml
SUSPENSION
Regulatory Information
SIN13654P
May 25, 2009
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
XJ02AC04
Company Information
Active Ingredients
Strength: 40mg/ml
Detailed Information
Contraindications
**CONTRAINDICATIONS:** NOXAFIL is contraindicated in patients with known hypersensitivity to NOXAFIL or any component of the product. Although not studied _in vitro_ or _in vivo_, coadministration of the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, or quinidine with NOXAFIL are contraindicated since increased plasma concentrations of these drugs can lead to QT prolongation and rare occurrences of torsade de pointes. Coadministration with the HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 is contraindicated since increased plasma concentration of these drugs can lead to rhabdomyolysis. Although not studied _in vitro_ or _in vivo_, NOXAFIL may increase the plasma concentrations of ergot alkaloids which may lead to ergotism. Coadministration of NOXAFIL and ergot alkaloids is contraindicated.
Indication Information
**INDICATIONS AND USAGE:** NOXAFIL Delayed Release Tablets and Oral Suspension are indicated for prophylaxis of invasive _Aspergillus_ and _Candida_ infections, including both yeasts and molds, in patients, 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or hematopoietic stem cell transplant (HSCT) recipients. NOXAFIL Delayed Release Tablets and Oral Suspension are indicated for use in the treatment of the following fungal infections in patients 13 years of age or older: - Refractory Invasive Fungal infections/Intolerant Patients with IFI: Fusariosis, zygomycosis, cryptococcosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients with disease refractory to other therapy, or patients who are intolerant of other therapy. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. NOXAFIL Oral Suspension is also indicated for use in the treatment of the following fungal infections in patients 13 years of age or older: - Oropharyngeal candidiasis in patients who have severe disease or who are immunocompromised, including in patients with disease that is refractory to itraconazole and fluconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.