Mycamine

Mycamine Manufacturers

• Astellas Pharma Us, Inc.
  

  ×

  Mycamine | Astellas Pharma Us, Inc.

  

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

  2.1 Dose and Schedule for Adults Table 1. Mycamine Dosage in Adult Patients * In patients treated successfully for candidemia and other Candida infections, the mean duration of treatment was 15 days (range 10-47 days). † In patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10-30 days). ‡ In hematopoietic stem cell transplant (HSCT) recipients who experienced success of prophylactic therapy, the mean duration of prophylaxis was 19 days (range 6-51 days).

  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

  A loading dose is not required. Typically, 85% of the steady-state concentration is achieved after three daily Mycamine doses.

  No dosing adjustments are required based on race, gender, or in patients with severe renal impairment or in patients with mild, moderate, or severe hepatic impairment [see Use in Specific Populations (8)].

  No dose adjustment for Mycamine is required with concomitant use of mycophenolate mofetil, cyclosporine, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, voriconazole, itraconazole, amphotericin B, ritonavir, or rifampin [see Drug Interactions (7)].

  2.2 Dose and Schedule for Pediatric Patients

  The recommended doses for pediatric patients based on indication and weight are shown in Table 2.

  Table 2. Mycamine Dosage in Pediatric Patients 4 months or older

  Indication

  Pediatric Dose Given Once Daily

  30 kg or less

  Greater than 30 kg

  Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses (1.1)

  2 mg/kg
  (maximum daily dose 100 mg)

  Treatment of Esophageal Candidiasis (1.2)

  3 mg/kg

  2.5 mg/kg (maximum daily dose 150 mg)

  Prophylaxis of Candida Infections in HSCT Recipients (1.3)

  1 mg/kg
  (maximum daily dose 50 mg)

  2.3 Directions for Reconstitution, Dilution, and Preparation

  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 50 mg vial: after reconstitution each mL contains 10 mg of micafungin sodium.
  Mycamine 100 mg vial: after reconstitution each mL contains 20 mg of micafungin sodium.

  As with all parenteral drug products, reconstituted Mycamine should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use material 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.

  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) (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 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.
  
  Note: To minimize the risk of infusion reactions, concentrations of greater than 1.5 mg/mL should be administered via central catheter [see Adverse Reactions (6.1)].
  
  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.

  Mycamine is preservative-free. Discard partially used vials.

  2.4 Infusion Volume and Duration

  Mycamine should be administered by intravenous infusion only. Infuse over one hour. More rapid infusions may result in more frequent histamine mediated reactions.

  An existing intravenous line should be flushed with 0.9% Sodium Chloride Injection, USP, prior to infusion of Mycamine.

  Pediatric Patients
  Mycamine should be infused over one hour. To minimize the risk of infusion reactions, concentrations of greater than 1.5 mg/mL should be administered via central catheter [see Adverse Reactions (6.1)].

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• Astellas Pharma Us, Inc.
  

  ×

  Mycamine | Astellas Pharma Us, Inc.

  

  ---

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

  2.1 Dose and Schedule for Adults Table 1. Mycamine Dosage in Adult Patients * In patients treated successfully for candidemia and other Candida infections, the mean duration of treatment was 15 days (range 10-47 days). † In patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10-30 days). ‡ In hematopoietic stem cell transplant (HSCT) recipients who experienced success of prophylactic therapy, the mean duration of prophylaxis was 19 days (range 6-51 days).

  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

  A loading dose is not required. Typically, 85% of the steady-state concentration is achieved after three daily Mycamine doses.

  No dosing adjustments are required based on race, gender, or in patients with severe renal impairment or in patients with mild, moderate, or severe hepatic impairment [see Use in Specific Populations (8)].

  No dose adjustment for Mycamine is required with concomitant use of mycophenolate mofetil, cyclosporine, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, voriconazole, itraconazole, amphotericin B, ritonavir, or rifampin [see Drug Interactions (7)].

  2.2 Dose and Schedule for Pediatric Patients

  The recommended doses for pediatric patients based on indication and weight are shown in Table 2.

  Table 2. Mycamine Dosage in Pediatric Patients 4 months or older

  Indication

  Pediatric Dose Given Once Daily

  30 kg or less

  Greater than 30 kg

  Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses (1.1)

  2 mg/kg
  (maximum daily dose 100 mg)

  Treatment of Esophageal Candidiasis (1.2)

  3 mg/kg

  2.5 mg/kg (maximum daily dose 150 mg)

  Prophylaxis of Candida Infections in HSCT Recipients (1.3)

  1 mg/kg
  (maximum daily dose 50 mg)

  2.3 Directions for Reconstitution, Dilution, and Preparation

  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 50 mg vial: after reconstitution each mL contains 10 mg of micafungin sodium.
  Mycamine 100 mg vial: after reconstitution each mL contains 20 mg of micafungin sodium.

  As with all parenteral drug products, reconstituted Mycamine should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use material 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.

  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) (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 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.
  
  Note: To minimize the risk of infusion reactions, concentrations of greater than 1.5 mg/mL should be administered via central catheter [see Adverse Reactions (6.1)].
  
  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.

  Mycamine is preservative-free. Discard partially used vials.

  2.4 Infusion Volume and Duration

  Mycamine should be administered by intravenous infusion only. Infuse over one hour. More rapid infusions may result in more frequent histamine mediated reactions.

  An existing intravenous line should be flushed with 0.9% Sodium Chloride Injection, USP, prior to infusion of Mycamine.

  Pediatric Patients
  Mycamine should be infused over one hour. To minimize the risk of infusion reactions, concentrations of greater than 1.5 mg/mL should be administered via central catheter [see Adverse Reactions (6.1)].

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  No Recall

  More Info