Noxafil

Noxafil Manufacturers

• Merck Sharp & Dohme Corp.
  

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  Noxafil | Merck Sharp & Dohme Corp.

  

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  General

  The prescriber should follow the specific dosing instructions for each formulation.

  Noxafil injection should be administered via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC), by slow intravenous infusion over approximately 90 minutes. 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 give Noxafil injection as an intravenous bolus injection.

  The delayed-release tablet and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation.

  Noxafil delayed-release tablets must be swallowed whole, and not be divided, crushed, or chewed. Noxafil delayed-release tablets should be taken with food [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)].

  Noxafil oral suspension should be administered 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.

  Coadministration 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)].

  Patients who have severe diarrhea or vomiting should be monitored closely for breakthrough fungal infections when receiving Noxafil delayed-release tablets or oral suspension.

  2.1 Instructions for Use with Noxafil Injection

  Dosing:

  Table 1: Dosing 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. Aseptically transfer 16.7 mL of posaconazole solution to an intravenous bag (or bottle) containing approximately 150 mL of 5% dextrose in water or sodium chloride 0.9%. Noxafil injection should only be administered with these diluents. Use of other infusion solutions may result in particulate formation. Noxafil injection is a single dose sterile solution without preservatives. 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). This medicinal product is for single use only and any unused solution should be discarded. 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.

  Based on the results of the study, the following drug products and diluents can be infused at the same time through the same intravenous line (or cannula) as Noxafil injection. Co-administered drug products should be prepared in 5% dextrose in water or sodium chloride 0.9%. Co-administration of drug products prepared in other infusion solutions may result in particulate formation.

  5% dextrose in water Amikacin sulfate Caspofungin Ciprofloxacin Daptomycin Dobutamine hydrochloride Famotidine Filgrastim Gentamicin sulfate Hydromorphone hydrochloride Levofloxacin Lorazepam Meropenem Micafungin Morphine sulfate Norepinephrine bitartrate Potassium chloride Sodium chloride 0.9% Vancomycin hydrochloride

  Any products or diluents not listed in the table above should not be coadministered through the same intravenous line (or cannula).

  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 (6.2)]. 2.2 Instructions for Use with Noxafil Delayed-Release Tablets Table 2: Dosing for Noxafil Delayed-Release Tablets Indication Dose and Duration of Therapy Prophylaxis of invasive Aspergillus and Candida infections 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. Duration of therapy is based on recovery from neutropenia or immunosuppression. 2.3 Instructions for Use with Noxafil Oral Suspension Table 3: Dosing for Noxafil Oral Suspension Indication Dose and Duration of Therapy Prophylaxis of invasive Aspergillus and Candida infections 200 mg (5 mL) three times a day. The duration of therapy is based on recovery from neutropenia or immunosuppression. Oropharyngeal Candidiasis Loading dose: 100 mg (2.5 mL) twice a day on the first day. Maintenance dose: 100 mg (2.5 mL) once a day for 13 days. Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole 400 mg (10 mL) twice a day. Duration of therapy should be based on the severity of the patient's underlying disease and clinical response.

  Administration Instructions for Noxafil oral suspension

  Shake Noxafil oral suspension well before use.

  Figure 1: A measured dosing spoon is provided, marked for doses of 2.5 mL and 5 mL.

  It is recommended that the spoon is rinsed with water after each administration and before storage.

  2.4 Administration Information

  Noxafil delayed-release tablets:

  Noxafil delayed-release tablets should be taken with food to enhance the oral absorption of posaconazole and optimize plasma concentrations. Noxafil delayed-release tablets should be used only for the prophylaxis indication. Noxafil delayed-release tablets generally provide higher plasma drug exposures than Noxafil oral suspension under both fed and fasted conditions, and therefore is the preferred oral formulation for the prophylaxis indication.

  Noxafil oral suspension:

  Each dose of Noxafil oral suspension should be administered during or immediately (i.e., within 20 minutes) following a full meal to enhance the oral absorption of posaconazole and optimize plasma concentrations. In patients who cannot eat a full meal and for whom Noxafil delayed-release tablets or Noxafil injection are not options, each dose of Noxafil oral suspension should be administered with a liquid nutritional supplement or an acidic carbonated beverage. In patients who cannot eat a full meal or tolerate an oral nutritional supplement or an acidic carbonated beverage and who do not have the option of taking Noxafil delayed-release tablets or Noxafil injection, an alternative antifungal therapy should be considered or patients should be monitored closely for breakthrough fungal infections. 2.5 Use in Patients with Renal Impairment

  The pharmacokinetics of Noxafil oral suspension are not significantly affected by renal impairment. Therefore, no adjustment is necessary for oral dosing in patients with mild to severe renal impairment.

  Noxafil injection should be avoided in patients with moderate or severe renal impairment (eGFR <50 mL/min), unless an assessment of the benefit/risk to the patient justifies the use of Noxafil injection. In patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <50 mL/min), receiving the Noxafil injection, accumulation of the intravenous vehicle, Betadex Sulfobutyl Ether Sodium (SBECD), is expected to occur. Serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to changing to oral Noxafil therapy.

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