Prophylaxis of Invasive Aspergillus and Candida Infections

NOXAFIL® Oral Suspension is indicated for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

Treatment of Oropharyngeal Candidiasis Including Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole

NOXAFIL is indicated for the treatment of Oropharyngeal Candidiasis, including Oropharyngeal Candidiasis refractory to itraconazole and/or fluconazole.

Dosage

Table 1

Administration Instructions

Shake NOXAFIL Oral Suspension well before use.

Figure 1: A measured dosing spoon is provided, marked for doses of 2.5 mL and 5 mL

It is recommended that the spoon is rinsed with water after each administration and before storage. Each dose of NOXAFIL should be administered with a full meal or with a liquid nutritional supplement or an acidic carbonated beverage (e.g., ginger ale) in patients who cannot eat a full meal. To enhance the oral absorption of posaconazole and optimize plasma concentrations:

• Each dose of NOXAFIL should be administered during or immediately (i.e., within 20 minutes) following a full meal. In patients who cannot eat a full meal, each dose of NOXAFIL should be administered with a liquid nutritional supplement or an acidic carbonated beverage. For patients who cannot eat a full meal or tolerate an oral nutritional supplement or an acidic carbonated beverage, alternative antifungal therapy should be considered or patients should be monitored closely for breakthrough fungal infections.
• Patients who have severe diarrhea or vomiting should be monitored closely for breakthrough fungal infections.
• Coadministration of drugs that can decrease the plasma concentrations of posaconazole should generally be avoided unless the benefit outweighs the risk. If such drugs are necessary, patients should be monitored closely for breakthrough fungal infections [see DRUG INTERACTIONS].

Dosage Forms and Strengths

NOXAFIL Oral Suspension is available in 4-ounce (123 mL) amber glass bottles with child-resistant closures (NDC 0085-1328-01) containing 105 mL of suspension (40 mg of posaconazole per mL).

Supplied with each bottle is a plastic dosing spoon calibrated for measuring 2.5-mL and 5-mL doses. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). DO NOT FREEZE.

Schering Corporation, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: 06/2012

Last reviewed on RxList: 6/29/2012
This monograph has been modified to include the generic and brand name in many instances.