Dosage for Adults

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

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.

Dosage for Pediatric Patients Younger than 4 Months of Age

Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination

The recommended dosage is 4 mg/kg once daily.

The safety and effectiveness of MYCAMINE have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3) and Microbiology (12.4)].

Directions for Reconstitution, Dilution, and Preparation

Do not mix or co-infuse MYCAMINE with other medications. MYCAMINE 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 MYCAMINE 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 MYCAMINE powder by swirling the vial. Do not vigorously shake the vial. Visually inspect the vial for particulate matter.

MYCAMINE 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 MYCAMINE 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 MYCAMINE 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 MYCAMINE 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) (20 mg/mL for the 100 mg vial), see example below:

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 MYCAMINE 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).

MYCAMINE is preservative-free. Discard partially used vials.

Infusion Volume and Duration

Administer MYCAMINE by intravenous infusion only. Infuse over one hour. More rapid infusions may result in more frequent histamine-mediated reactions [see Warnings and Precautions (5.5)].

Flush an existing intravenous line with 0.9% Sodium Chloride Injection, USP, prior to infusion of MYCAMINE.

Pediatric Patients

MYCAMINE should be infused over one hour. 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)].