1.2 Treatment of Oropharyngeal Candidiasis Including Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole
 
Noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole.

2 DOSAGE AND ADMINISTRATION

General
 
The prescriber should follow the specific dosing instructions for each formulation. The delayed-release tablet and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation.
 
Noxafil delayed-release tablets should be swallowed whole, and not be divided, crushed, or chewed. Noxafil delayed-release tablets should be taken with food [see Dosage and Administration (2.3)].
 
Noxafil oral suspension 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.
 
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 (7.6, 7.7, 7.8, 7.9, 7.13)].
 
Patients who have severe diarrhea or vomiting should be monitored closely for breakthrough fungal infections.

2.1 Instructions for use with Noxafil Delayed-Release Tablets
 
Table 1: Dosing for Noxafil Delayed-Release Tablets

Indication
 
Dose and Duration of Therapy
 
Prophylaxis of invasive Aspergillus and Candida infections Loading dose: 300 mg (three 100 mg delayed-release tablets) twice a day on the first day.
 Maintenance dose: 300 mg (three 100 mg delayed-release tablets) once a day, starting on the second day. Duration of therapy is based on recovery from neutropenia or immunosuppression.

2.2 Instructions for use with Noxafil Oral Suspension
 
Table 2: Dosing for Noxafil Oral Suspension

Indication
 
Dose and Duration of Therapy

Prophylaxis of invasive Aspergillus and Candida infections 200 mg (5 mL) three times a day. The duration of therapy is based on recovery from neutropenia or immunosuppression.
Oropharyngeal Candidiasis Loading dose: 100 mg (2.5 mL) twice a day on the first day.
 Maintenance dose: 100 mg (2.5 mL) once a day for 13 days.
Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole 400 mg (10 mL) twice a day. Duration of therapy should be based on the severity of the patient's underlying disease and clinical response.

Administration Instructions for Noxafil oral suspension
 
Shake Noxafil oral suspension well before use.
 
Image of Figure 1
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.

2.3 Administration Information
 
To enhance the oral absorption of Noxafil and optimize plasma concentrations:
• Noxafi