Posaconazoledosage

Posaconazole formulations are supplied in different dose strengths of posaconazole, are approved for different indications, age groups, and weights, have different dosages and duration of therapy; and have different preparation and administration instructions.

Posaconazole oral suspension is not substitutable with posaconazole delayed-release tablets or posaconazole powder for delayed-release oral suspension due to the differences in the dosing of each formulation. Therefore, follow the specific dosage recommendations for each of the formulations.

Administer posaconazole oral suspension with a full meal.

See the full prescribing information for important administration instructions for posaconazole oral suspension

For adult and pediatric patients aged 13 years of age and older, see the Full Prescribing Information for dosing recommendations for posaconazole oral suspension based on the indication, age, and weight associated with the dosage form.

2.1 Important

Administration Instructions Posaconazole injection, posaconazole delayed-release tablets, posaconazole oral suspension and posaconazole PowderMix for delayed-release oral suspension are supplied in different dose strengths of posaconazole, are approved for different indications, age groups and weights; have different dosages and duration of therapy; and have different preparation and administration instructions. Therefore, select the recommended dosage form based on the indication, age group, and weight and carefully follow the recommended dosage, preparation and administration instructions described for each product, and the following important administration instructions described below. Non-substitutable: Posaconazole oral suspension is not substitutable with posaconazole delayed-release tablets or posaconazole powder for delayed-release oral suspension due to the differences in the dosing of each formulation. Therefore, follow the specific dosage recommendations for each of the formulations. Posaconazole oral suspension:

Administer 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.

2.2 Recommended

Dosage of Posaconazole Oral Suspension in Adult Patients The recommended dosage of Posaconazole oral suspension in adult patients for the treatment of invasive aspergillosis, prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, or for the treatment of oropharyngeal candidiasis (OPC) is shown in Table 1.

Table 1: Recommended Dosage of Posaconazole Oral Suspension in Adult Patients Dosage Duration of Therapy Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole Oral Suspension: 200 mg (5 mL) three times a day.

Maintenance dose: Duration of therapy is based on recovery from neutropenia or immunosuppression. Oropharyngeal Candidiasis (OPC) Posaconazole Oral Suspension: Loading dose: 100 mg (2.5 mL) twice a day on the first day.

Maintenance dose: 100 mg (2.5 mL) once a day thereafter.

Loading dose: 1 day Maintenance dose: 13 days OPC Refractory (rOPC) to Itraconazole and/or Fluconazole Posaconazole Oral Suspension: 400 mg (10 mL) twice a day. Duration of therapy is based on the severity of the patient’s underlying disease and clinical response.

2.3 Recommended

Dosage of Posaconazole Oral Suspension for the Prophylaxis of Invasive Aspergillus and Candida Infections in Pediatric Patients 13 Years of Age and Older The recommended dosage of posaconazole oral suspension for pediatric patients ages 13 years of age and older for the prophylaxis of invasive Aspergillus and Candida infections is shown in Table 3.

Table 3: Recommended Dosage of Posaconazole Oral Suspension for the Prophylaxis of Invasive Aspergillus and Candida Infections in Pediatric Patients (13 Years of Age and Older) Recommended Pediatric Dosage of Posaconazole Oral Suspension Duration of Therapy 200 mg (5 mL) three times a day Duration of therapy is based on recovery from neutropenia or immunosuppression.

2.4 Recommended

Dosage of Posaconazole Oral Suspension for the Treatment of Oropharyngeal Candidiasis in Pediatric Patients 13 Years of Age and Older The recommended dosage of posaconazole oral suspension for the treatment of oropharyngeal candidiasis (OPC) and OPC refractory (rOPC) to itraconazole and/or fluconazole in pediatric patients 13 years of age and older is shown in Table 6. The posaconazole injection, posaconazole delayed-release tablets, and posaconazole PowderMix for delayed-release oral suspension products are not approved for the treatment of oropharyngeal candidiasis in pediatric patients.

Table 6: Recommended Dosage of Posaconazole Oral Suspension for the Treatment of OPC and rOPC in Pediatric Patients (13 Years of Age and Older) Recommended Pediatric Dosage of Posaconazole Oral Suspension Duration of Therapy Oropharyngeal Candidiasis (OPC) Loading dose: 100 mg (2.5 mL) twice daily on the first day Maintenance dose: 100 mg (2.5 mL) once daily Loading dose: 1 day Maintenance dose: 13 days OPC Refractory (rOPC) to Itraconazole and/or Fluconazole 400 mg (10 mL) twice daily Duration of therapy is based on the severity of the patient’s underlying disease and clinical response.

2.8 Administration

Instructions for Posaconazole Oral Suspension Administer posaconazole oral suspension 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. For patients who cannot eat a full meal, use posaconazole delayed-release tablets instead of the posaconazole oral suspension for the prophylaxis of invasive Aspergillus and Candida infections in those who are at high risk of developing these infections due to being severely immunocompromised. This is because posaconazole delayed-release tablets provide higher plasma drug exposures than posaconazole oral suspension under fasted condition. For those patients using the posaconazole oral suspension:

Shake posaconazole oral suspension well before use.

Administer with measured dosing spoon provided in the package (see Figure 1). Figure 1: Measured dosing spoon provided in the package marked for doses of 2.5 mL and 5 mL.

Administer each dose of posaconazole oral suspension during or immediately (i.e., within 20 minutes) following a full meal.

In patients who cannot eat a full meal and for whom posaconazole delayed-release tablets or posaconazole injection are not options, administer each dose of posaconazole oral suspension with a liquid nutritional supplement or an acidic carbonated beverage (e.g., ginger ale). If these patients cannot tolerate an oral nutritional supplement or an acidic carbonated beverage either use: o An alternative antifungal therapy, or o Posaconazole oral suspension and closely monitor patients for breakthrough fungal infections.

Rinse the spoon with water after each administration and before storage. Figure 1 - Measured dosing spoon

2.9 Non-substitutability between

Posaconazole Oral Suspension and Other Formulations Posaconazole oral suspension is not substitutable with posaconazole delayed-release tablets or posaconazole powder for delayed-release oral suspension due to the differences in the dosing of each formulation. Therefore, follow the specific dosage recommendations for each of the formulations.

2.11 Dosage Modifications in

Patients with Renal Impairment The recommended dosage of posaconazole oral suspension is the same in patients with renal impairment compared to those with normal renal function.