POSACONAZOLE
POSACONAZOLE- posaconazole tablet, delayed release
SpecGx LLC
1 INDICATIONS AND USAGE
1.2 Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients 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 [see Clinical Studies (14.2)] as follows:
- Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older
Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.’s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Non-substitutablePosaconazole delayed-release tablets are not substitutable with Noxafil® Oral Suspension or Noxafil® PowderMix 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 [see Dosage and Administration (2.2, 2.3)].
Posaconazole delayed-release tablets
- Swallow tablets whole. Do not divide, crush, or chew.
- Administer with or without food [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)].
- For patients who cannot eat a full meal, posaconazole delayed-release tablets should be used instead of Noxafil® Oral Suspension for the prophylaxis indication. Posaconazole delayed-release tablets generally provide higher plasma drug exposures than Noxafil® Oral Suspension under both fed and fasted conditions.
2.2 Dosing Regimen in Adult Patients
Indication | Dose and Frequency | Duration of Therapy |
Prophylaxis of invasive Aspergillus and Candida infections | Posaconazole Delayed-Release Tablets: 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. | Loading dose:1 day Maintenance dose:Duration of therapy is based on recovery from neutropenia or immunosuppression. |
2.3 Dosing Regimen in Pediatric Patients (ages 13 to less than 18 years of age)
The recommended dosing regimen of posaconazole delayed-release tablets for pediatric patients 13 to less than 18 years of age is shown in Table 2 [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)].
Indication | Delayed-Release Tablet | Duration of therapy |
Prophylaxis of Invasive Aspergillus and Candida infections | Loading dose : 300 mg twice daily on the first day Maintenance dose:300 mg once daily | Duration of therapy is based on recovery from neutropenia or immunosuppression. |
Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.’s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.5 Administration Instructions for Posaconazole Delayed-Release Tablets
- Swallow tablets whole. Do not divide, crush, or chew.
- Administer posaconazole delayed-release tablets with or without food [see Clinical Pharmacology (12.3)].
2.7 Non-Substitutability Between Noxafil® Oral Suspension and Other Formulations
Posaconazole delayed-release tablets are not substitutable with Noxafil® Oral Suspension or Noxafil® PowderMix 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 [see Dosage and Administration (2.2, 2.3)].
2.9 Dosage Adjustments in Patients with Renal Impairment
The pharmacokinetics of posaconazole delayed-release tablets are not significantly affected by renal impairment. Therefore, no adjustment is necessary for oral dosing in patients with mild to severe renal impairment.
3 DOSAGE FORMS AND STRENGTHS
Posaconazole delayed-release tablets are available as yellow, modified, oval, convex tablets debossed with a logo “M” inside a square on one side and “100” on the opposite side containing 100 mg of posaconazole.
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