NOXAFIL

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

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.

2.2 Dosage, Preparation, Intravenous Line Compatibility and Administration of Noxafil Injection

Dosage:

Table 1: Dosage for Noxafil Injection
Indication Dose and Duration of Therapy
Prophylaxis of invasive Aspergillus and Candida infections 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. Duration of therapy is based on recovery from neutropenia or immunosuppression.

Preparation:

  • Equilibrate the refrigerated vial of Noxafil (posaconazole) injection to room temperature.
  • To prepare the required dose, aseptically transfer one vial (16.7 mL) of Noxafil injection (containing 300 mg of posaconazole in solution) to an intravenous bag (or bottle) of a compatible admixture diluent (as described in Table 2), to achieve a final concentration of posaconazole that is between 1 mg/mL and 2 mg/mL. Use of other diluents is not recommended because they may result in particulate formation.
  • Noxafil injection is a single dose sterile solution without preservatives. Discard any unused portion.
  • Once admixed, the product should be used immediately. If not used immediately, the solution can be stored up to 24 hours refrigerated 2-8°C (36-46°F).
  • Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Once admixed, the solution of Noxafil ranges from colorless to yellow. Variations of color within this range do not affect the quality of the product.

Intravenous Line Compatibility:

A study was conducted to evaluate physical compatibility of Noxafil injection with injectable drug products and commonly used intravenous diluents during simulated Y-site infusion. Compatibility was determined through visual observations, measurement of particulate matter and turbidity. Compatible diluents and drug products are listed in Tables 2 and 3 below. Any diluents or drug products not listed in the tables below should not be co-administered through the same intravenous line (or cannula).

  • Noxafil injection can be infused at the same time through the same intravenous line (or cannula) with the following compatible diluents:
Table 2: Compatible Diluents
0.45% sodium chloride
0.9% sodium chloride
5% dextrose in water
5% dextrose and 0.45% sodium chloride
5% dextrose and 0.9% sodium chloride
5% dextrose and 20 mEq potassium chloride
  • Noxafil injection can be infused at the same time through the same intravenous line (or cannula) with the following drug products prepared in 5% dextrose in water or sodium chloride 0.9%. Co-administration of drug products prepared in other diluents may result in particulate formation.
Table 3: Compatible Drugs
Amikacin sulfate
Caspofungin
Ciprofloxacin
Daptomycin
Dobutamine hydrochloride
Famotidine
Filgrastim
Gentamicin sulfate
Hydromorphone hydrochloride
Levofloxacin
Lorazepam
Meropenem
Micafungin
Morphine sulfate
Norepinephrine bitartrate
Potassium chloride
Vancomycin hydrochloride

Incompatible Diluents:

Noxafil injection must not be diluted with the following diluents:

Lactated Ringer’s solution
5% dextrose with Lactated Ringer’s solution4.2% sodium bicarbonate

Administration:

  • Noxafil injection must be administered through a 0.22 micron polyethersulfone (PES) or polyvinylidene difluoride (PVDF) filter.
  • Administer via a central venous line, including a central venous catheter or PICC by slow infusion over approximately 90 minutes. Noxafil injection is not for bolus administration.
  • If a central venous catheter is not available, Noxafil injection may be administered through a peripheral venous catheter 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 treatment.
  • When multiple dosing is required, the infusion should be done via a central venous line. When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes. Note: In clinical trials, multiple peripheral infusions given through the same vein resulted in infusion site reactions [see Adverse Reactions (6.1)].

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