NOXAFIL

NOXAFIL- posaconazole suspension
NOXAFIL- posaconazole tablet, coated
NOXAFIL- posaconazole solution
NOXAFIL- posaconazole powder, for suspension
Merck Sharp & Dohme LLC

1 INDICATIONS AND USAGE

1.1 Treatment of Invasive Aspergillosis

Noxafil® injection and Noxafil delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older.

1.2 Prophylaxis of Invasive Aspergillus and Candida Infections

Noxafil is 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 (14.1)] as follows:

  • Noxafil injection: adults and pediatric patients 2 years of age and older
  • Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg
  • Noxafil oral suspension: adults and pediatric patients 13 years of age and older
  • Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 40 kg or less

1.3 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 in adults and pediatric patients 13 years of age and older.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Non-substitutable

Noxafil oral suspension is not substitutable with Noxafil delayed-release tablets 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, 2.8)].

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 (2.4)].
  • 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.
  • Do NOT administer Noxafil injection as an intravenous bolus injection.

Noxafil 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, Noxafil delayed-release tablets should be used instead of Noxafil oral suspension for the prophylaxis indication. Noxafil delayed-release tablets generally provide higher plasma drug exposures than Noxafil oral suspension under both fed and fasted conditions [see Dosage and Administration (2.6)].

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 (2.6)].
  • 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 PowderMix for delayed-release oral suspension

  • Administer with food [see Clinical Pharmacology (12.3)].
  • Administration with alcohol is not recommended [see Drug Interactions (7.15)].
  • To ensure delivery of the correct dose, ONLY the provided notched tip syringes must be used for preparation and administration. The design of the notched tip syringe prevents aggregation of the suspension during preparation and administration [see Dosage and Administration (2.8)].

2.2 Dosing Regimen in Adult Patients

Table 1: Dosing Regimens in Adult Patients
Indication Dose and Frequency Duration of Therapy
Treatment of invasive Aspergillosis

Noxafil Injection:

Loading dose: 300 mg Noxafil injection intravenously twice a day on the first day.

Maintenance dose: 300 mg Noxafil injection intravenously once a day, starting on the second day.

Noxafil 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.

Switching between the intravenous and delayed-release tablets is acceptable. A loading dose is not required when switching between formulations.

Loading dose:1 day

Maintenance dose:Recommended total duration of therapy is 6 to 12 weeks.

Prophylaxis of invasive Aspergillus and Candida infections Noxafil Injection: Loading dose: 300 mg Noxafil injection intravenously twice a day on the first day.Maintenance dose: 300 mg Noxafil injection intravenously once a day thereafter. Noxafil 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. Noxafil Oral Suspension: 200 mg (5 mL) three times a day. Loading dose:1 day Maintenance dose: Duration of therapy is based on recovery from neutropenia or immunosuppression.
Oropharyngeal Candidiasis (OPC) Noxafil 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 Noxafil 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.

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