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Noxafil Dosage

Generic name: posaconazole 40mg in 1mL
Dosage forms: oral suspension; tablet, injection
Drug class: Azole antifungals

Medically reviewed by Drugs.com. Last updated on Sep 6, 2022.

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)].

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.

Dosing Regimen in Pediatric Patients (ages 2 to less than 18 years of age)

The recommended dosing regimen of Noxafil for pediatric patients 2 to less than 18 years of age is shown in Tables 2, 3, and 4 [see Dosage and Administration (2.5, 2.6, 2.8) and Clinical Pharmacology (12.3)].

Noxafil PowderMix for delayed-release oral suspension is not recommended for use in patients who weigh greater than 40 kg because the recommended dosage cannot be achieved with this formulation.

Table 2: Noxafil Delayed-Release Tablet and Noxafil Injection Dosing Regimens for Pediatric Patients (ages 2 to less than 18 years of age)
Recommended Pediatric Dosage and Formulation
Indication Weight/Age Delayed-Release Tablet Injection Duration of therapy
Prophylaxis of invasive Aspergillus and Candida infections Less than or equal to 40 kg (2 to less than 18 years of age) Not Applicable Loading dose:
6 mg/kg up to a maximum of 300 mg twice daily on the first day
Duration of therapy is based on
recovery from neutropenia or
immunosuppression.
Greater than 40 kg (2 to less than 18 years of age) Loading dose:
300 mg twice daily on the first day

Maintenance dose:
300 mg once daily


Maintenance dose:

6 mg/kg up to a maximum of 300 mg once daily
Treatment of invasive Aspergillosis 13 to less than 18 years of age regardless of weight. Loading dose:
300 mg (three 100 mg delayed-release tablets) twice a day on the first day.
Loading dose:
300 mg Noxafil injection intravenously twice a day on the first day.
Loading dose:
1 day

Maintenance dose:
300 mg (three 100 mg delayed-release tablets) once a day, starting on the second day.

Maintenance dose:
300 mg Noxafil injection intravenously once a day, starting on the second day.
Maintenance dose:
Recommended total duration of therapy is 6 to 12 weeks.

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

Switching between the intravenous and delayed-release tablets is acceptable. A loading dose is not required when switching between formulations.
Table 3: Noxafil Oral Suspension Dosing Regimens for Pediatric Patients (ages 13 to less than 18 years of age)
Indication Loading Dose (volume) and
frequency
Maintenance Dose
(volume) and frequency
Duration of therapy
Prophylaxis of invasive Aspergillus and Candida infections 200 mg (5 mL) three times a day 200 mg (5 mL) three times a day Duration of therapy is based on recovery from neutropenia or immunosuppression.
Oropharyngeal Candidiasis (OPC) 100 mg (2.5 mL) twice daily on the first day 100 mg (2.5 mL) once daily 13 days
OPC Refractory (rOPC) to Itraconazole and/or Fluconazole 400 mg (10 mL) twice daily 400 mg (10 mL) twice daily Duration of therapy is based on the severity of the patient’s underlying disease and clinical response.
Table 4: Noxafil PowderMix for Delayed-Release Oral Suspension Dosing Regimen in Pediatric Patients (ages 2 to less than 18 years of age, weighing 10 to 40 kg)
Indication Weight (kg) Loading Dose (volume) Maintenance Dose (volume)
Prophylaxis of invasive Aspergillus and Candida infections 10 to less than 12 90 mg (3 mL) twice daily on the first day 90 mg (3 mL) once daily
12 to less than 17 120 mg (4 mL) twice daily on the first day 120 mg (4 mL) once daily
17 to less than 21 150 mg (5 mL) twice daily on the first day 150 mg (5 mL) once daily
21 to less than 26 180 mg (6 mL) twice daily on the first day 180 mg (6 mL) once daily
26 to less than 36 210 mg (7 mL) twice daily on the first day 210 mg (7 mL) once daily
36 to 40 240 mg (8 mL) twice daily on the first day 240 mg (8 mL) once daily

Preparation, Intravenous Line Compatibility, and Administration of Noxafil Injection

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 5), 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 from the vial.
  • Once admixed, the diluted solution of Noxafil in the intravenous bag (or bottle) should be used immediately. If not used immediately, the solution can be stored up to 24 hours refrigerated 2 to 8°C (36 to 46°F). Discard any unused portion.
  • 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 5 and 6 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 5: 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 6: 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 solution
4.2% 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)].

Administration Instructions for Noxafil Delayed-Release Tablets

  • Swallow tablets whole. Do not divide, crush, or chew.
  • Administer Noxafil delayed-release tablets with or without food [see Clinical Pharmacology (12.3)].

Administration Instructions for Noxafil Oral Suspension

  • Shake Noxafil oral suspension well before use. Administer with measured dosing spoon (see Figure 1) provided.
Figure 1
Figure 1: A measured dosing spoon is provided, marked for doses of 2.5 mL and 5 mL.
  • Rinse the spoon with water after each administration and before storage.
  • Administer each dose of Noxafil oral suspension during or immediately (i.e., within 20 minutes) following a full meal [see 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 provide higher plasma drug exposures than Noxafil oral suspension under fasted conditions [see Dosage and Administration (2.1)].
  • In patients who cannot eat a full meal and for whom Noxafil delayed-release tablets or Noxafil injection are not options, administer each dose of Noxafil oral suspension with a liquid nutritional supplement or an acidic carbonated beverage (e.g., ginger ale).
  • For 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.

Non-substitutability between Noxafil Oral Suspension and Other Formulations

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)].

Preparation and Administration Instructions for Noxafil PowderMix for Delayed-Release Oral Suspension (pediatric patients ages 2 to less than 18 years of age)

For details on preparation and administration of Noxafil PowderMix for delayed-release oral suspension, see Instructions for Use.

Preparation Instructions

  • Do not open packet in the Noxafil PowderMix kit until ready to prepare the medicine.
  • Remove cap from the mixing liquid and push the bottle adapter into the neck of the bottle. Once in place, the bottle adapter stays in the bottle. Remove 9 mL of mixing liquid using the provided BLUE syringe. Put the cap back on the bottle.
    ONLY the mixing liquid in the kit should be used to prepare Noxafil PowderMix for delayed-release oral suspension.
  • Using the provided mixing cup, combine 9 mL of mixing liquid and the entire contents of one packet in the Noxafil PowderMix kit and mix. Each single-use packet in the Noxafil PowderMix kit contains 300 mg of posaconazole to be suspended in 9 mL of mixing liquid giving a final concentration of approximately 30 mg per mL.
  • Shake the mixing cup vigorously for 45 seconds to mix the powder and mixing liquid from the Noxafil PowderMix kit. Check to make sure the powder is mixed. The mixture should look cloudy and free of clumps.
  • The reconstituted suspension must be used within 1 hour. Discard unused portion of the prepared drug product.

Administration Instructions

  • Administer Noxafil PowderMix for delayed-release oral suspension with food.
  • Choose the correct syringe based on the prescribed dose:
    • Use 3 mL (GREEN) syringe if dose is 3 mL or less.
    • Use 10 mL (BLUE) syringe if dose is more than 3 mL.
  • Measure the prescribed dose volume with the notched tip syringe provided with the kit and administer the dose orally. Administer the dose orally within 1 hour of mixing.
  • Not all of the Noxafil PowderMix in the mixing cup will be used. There will be some left over in the mixing cup.
  • The maximum dose that can be accurately withdrawn from the mixing cup after reconstitution is 240 mg (8 mL).
  • 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.
  • Discard any remaining suspension. The mixing cup may be hand washed and reused. Alternatively, the mixing cup may be discarded, and a similar mixing cup with a lid may be used for subsequent doses.
  • The notched tip syringes may also be hand washed and reused. For additional supply, a separate box of notched tip syringes is provided with the Noxafil PowderMix kit.

Dosage Adjustments in Patients with Renal Impairment

The pharmacokinetics of Noxafil oral suspension and Noxafil 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.

  • 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.