Micafungin

MICAFUNGIN- micafungin injection, powder, lyophilized, for solution
Hikma Pharmaceuticals USA Inc.

1 INDICATIONS AND USAGE

Micafungin for Injection is indicated for:

  • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)].
  • Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)].
  • Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].

    Limitations of Use

  • Micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida.
  • The efficacy of micafungin for injection against infections caused by fungi other than Candida has not been established.

Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine® (micafungin for injection). However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Adults

The recommended dosage for adult patients based on indications are shown in Table 1.

Table 1. Micafungin for Injection Dosage in Adult Patients

Indication

Recommended Reconstituted Dose Once Daily

Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses*

100 mg

Treatment of Esophageal Candidiasis

150 mg

Prophylaxis of Candida Infections in HSCT Recipients§

50 mg

* In patients treated successfully for candidemia and other Candida infections, the mean duration of treatment was 15 days (range 10 to 47 days).
In patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10 to 30 days).
§ In hematopoietic stem cell transplant (HSCT) recipients who experienced success of prophylactic therapy, the mean duration of prophylaxis was 19 days (range 6 to 51 days).

2.2 Dosage for Pediatric Patients 4 Months and Older

The recommended dosage for pediatric patients 4 months of age and older based on indication and weight are shown in Table 2.

Table 2. Micafungin for Injection Dosage in Pediatric Patients (4 Months and Older)

Indication

Dosage for Pediatric Patients 4 Months of Age and Older

30 kg or less

Greater than 30 kg

Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses

2 mg/kg once daily (maximum daily dose 100 mg)

Treatment of Esophageal Candidiasis

3 mg/kg once daily

2.5 mg/kg once daily (maximum daily dose 150 mg)

Prophylaxis of Candida Infections in HSCT Recipients

1 mg/kg once daily (maximum daily dose 50 mg)

Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine® (micafungin for injection). However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2.4 Directions for Reconstitution, Dilution, and Preparation

Do not mix or co-infuse micafungin for injection with other medications. Micafungin for injection has been shown to precipitate when mixed directly with a number of other commonly used medications. Please read this entire section carefully before beginning reconstitution.

Reconstitution

Reconstitute micafungin for injection vials by aseptically adding 5 mL of one of the following compatible solutions:

  • 0.9% Sodium Chloride Injection, USP (without a bacteriostatic agent)
  • 5% Dextrose Injection, USP

To minimize excessive foaming, gently dissolve the micafungin for injection powder by swirling the vial. Do not vigorously shake the vial. Visually inspect the vial for particulate matter.

Micafungin for injection 50 mg vial: after reconstitution each mL contains 10 mg of micafungin.
Micafungin for injection 100 mg vial: after reconstitution each mL contains 20 mg of micafungin.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if there is any evidence of precipitation or foreign matter. Aseptic technique must be strictly observed in all handling since no preservative or bacteriostatic agent is present in micafungin for injection or in the materials specified for reconstitution and dilution.

The reconstituted product should be protected from light and may be stored in the original vial for up to 24 hours at room temperature, 25°C (77°F).

Dilution and Preparation

The diluted solution should be protected from light. It is not necessary to cover the infusion drip chamber or the tubing.

Adult Patients:

  1. Add the appropriate volume of reconstituted micafungin for injection into 100 mL of 0.9% Sodium Chloride Injection, USP or 100 mL of 5% Dextrose Injection, USP.
  2. Appropriately label the bag.

Pediatric Patients:

  1. Calculate the total micafungin for injection dose in milligrams (mg) by multiplying the recommended pediatric dose (mg/kg) for a given indication [see Table 2] and the weight of the patient in kilograms (kg).
  2. To calculate the volume (mL) of drug needed, divide the calculated dose (mg) from step 1 by the final concentration of the selected reconstituted vial(s) (either 10 mg/mL for the 50 mg vial or 20 mg/mL for the 100 mg vial), see example below:
    Using 50 mg vials:
    Divide the calculated mg dose (from step 1) by 10 mg/mL to determine the volume (mL) needed.
    OR
    Using 100 mg vials:
    Divide the calculated mg dose (from step 1) by 20 mg/mL to determine the volume (mL) needed.
  3. Withdraw the calculated volume (mL) of drug needed from the selected concentration and size of reconstituted micafungin for injection vial(s) used in Step 2 (ensure the selected concentration and vial size used to calculate the dose is also used to prepare the infusion).
  4. Add the withdrawn volume of drug (step 3) to a 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP intravenous infusion bag or syringe. Ensure that the final concentration of the solution is between 0.5 mg/mL to 4 mg/mL.
    To decrease the risk of infusion reactions, concentrations above 1.5 mg/mL should be administered via central catheter [see Warnings and Precautions (5.5)].
  5. Appropriately label the infusion bag or syringe. For concentrations above 1.5 mg/mL, if required, label to specifically warn to administer the solution via central catheter.

The diluted infusion bag should be protected from light and may be stored for up to 24 hours at room temperature, 25°C (77°F).

Micafungin for injection is preservative-free. Discard partially used vials.

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