NOXAFIL- posaconazole suspension
NOXAFIL- posaconazole tablet, coated
NOXAFIL- posaconazole solution
Merck Sharp & Dohme Corp.
1 INDICATIONS AND USAGE
1.1 Prophylaxis of Invasive Aspergillus and Candida Infections
Noxafil� injection, delayed-release tablets, and oral suspension are indicated for 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.
Noxafil injection is indicated in patients 18 years of age and older.
Noxafil delayed-release tablets and oral suspension are indicated in patients 13 years of age and older.
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
2.1 Important Administration Instructions for Noxafil Injection, Noxafil Delayed-Release Tablets and Noxafil Oral Suspension
Noxafil delayed-release tablets and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation [see Dosage and Administration (2.3, 2.4, 2.5)].
Noxafil injection
Administer via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC), by slow intravenous infusion over approximately 90 minutes [see Dosage and Administration (2.2)].
If a central venous catheter is not available, Noxafil injection may be administered through a peripheral venous catheter by slow intravenous infusion over 30 minutes only as a single dose in advance of central venous line placement or to bridge the period during which a central venous line is replaced or is in use for other intravenous treatment.
When multiple dosing is required, the infusion should be done via a central venous line.
Never administer Noxafil injection as an intravenous bolus injection.
Noxafil delayed-release tablets
Swallow tablets whole. Do not divide, crush, or chew.
Administer with food [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].
Noxafil 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 [see Dosage and Administration (2.4)]
Co-administration 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)]
Noxafil delayed-release tablets and Noxafil oral suspension
Patients who have severe diarrhea or vomiting should be monitored closely for breakthrough fungal infections when receiving Noxafil delayed-release tablets or oral suspension.