Micafungin

What is Micafungin?

• Micafungin (Mycamine) is an echinocandin used to treat and prevent invasive fungal infections including candidemia, abscesses and esophageal candidiasis.

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Micafungin

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Micafungin ball-and-stick

What are the uses of this medicine?

Micafungin (Mycamine) is used in adult and pediatric patients for:

• Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.
• Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.
• Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.
• Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).

Limitations of Use:

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

How does this medicine work?

• Micafungin is a member of the echinocandin class of antifungal agents.
• Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an essential component of fungal cell walls, which is not present in mammalian cells.
• The echinocandins are a relatively new class of antifungal agents, whose activity is due to inhibition of glucan synthetase, the enzyme that is responsible for synthesis of β-1, 3-D-glucan, an essential component of the cell wall of filamentous fungi, such as Aspergillus and Candida species.
• This enzyme inhibition results in alteration in the fungal membrane integrity, followed by cell ballooning and, for Candida cells, lysis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to micafungin, any component of MYCAMINE, or other echinocandins.

What drug interactions can this medicine cause?

• Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary.

Is this medicine FDA approved?

• Micafungin was approved for use in the United States in 2005.

How should this medicine be used?

Recommended dosage: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses:

• Adult:100 mg daily
• Pediatric Patients (4 Months and Older 30 kg or less): 2 mg/kg/day (maximum 100 mg daily)
• Pediatric Patients (4 Months and Older greater than 30 kg): 2 mg/kg/day (maximum 100 mg daily)
• Pediatric Patients Younger than 4 Months of Age: 4 mg/kg/day

Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without Meningoencephalitis and/or Ocular Dissemination :

• Adult:100 mg daily
• Pediatric Patients (4 Months and Older 30 kg or less): 2 mg/kg/day (maximum 100 mg daily)
• Pediatric Patients (4 Months and Older greater than 30 kg): 2 mg/kg/day (maximum 100 mg daily)
• Pediatric Patients Younger than 4 Months of Age: 4 mg/kg/day

Treatment of Esophageal Candidiasis:

• Adult:150 mg daily
• Pediatric Patients (4 Months and Older 30 kg or less):3 mg/kg/day
• Pediatric Patients (4 Months and Older greater than 30 kg):2.5 mg/kg/day(maximum 150 mg daily)
• Pediatric Patients Younger than 4 Months of Age: Not approved

Prophylaxis of Candida Infections in HSCT Recipients:

• Adult:50 mg daily
• Pediatric Patients (4 Months and Older 30 kg or less):1 mg/kg/day (maximum 50 mg daily)
• Pediatric Patients (4 Months and Older greater than 30 kg):1 mg/kg/day (maximum 50 mg daily)
• Pediatric Patients Younger than 4 Months of Age: Not approved

Administration:

• Administer MYCAMINE by intravenous infusion only.
• Infuse over one hour.
• More rapid infusions may result in more frequent histamine-mediated reactions.

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

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 50 mg single-dose vial.
• injection: 100 mg single-dose vial.

This medicine is available in fallowing brand namesː

• MYCAMINE

What side effects can this medication cause?

The most common side effects of this medicine include: In adult and pediatric patients:

• diarrhea
• nausea
• vomiting
• abdominal pain
• pyrexia
• thrombocytopenia
• neutropenia
• headache

In pediatric patients younger than 4 months of age:

• sepsis
• acidosis
• anemia
• oxygen saturation decreased
• hypokalemia

What special precautions should I follow?

• Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving MYCAMINE. Discontinue MYCAMINE and administer appropriate treatment.
• Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria have been reported. Monitor rate of hemolysis. Discontinue if severe.
• Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with MYCAMINE. . Monitor hepatic function. Discontinue if severe dysfunction occurs.
• Elevations in BUN and creatinine, and isolated cases of significant renal impairment or acute renal failure have been reported in patients who received MYCAMINE. Monitor renal function.
• Infusion and Injection Site Reactions can occur including rash, pruritus, facial swelling, and vasodilatation. Monitor infusion closely, slow infusion rate if necessary.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings from animal studies, MYCAMINE may cause fetal harm when administered to a pregnant woman.
• There is insufficient human data on the use of MYCAMINE in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness of MYCAMINE for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and for prophylaxis of Candida infections in patients undergoing HSCT have been established in pediatric patients 4 months of age and older.
• The safety and effectiveness of MYCAMINE for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination at a dosage of 4 mg/kg once daily have been established in pediatric patients younger than 4 months of age.
• 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.

The safety and effectiveness of MYCAMINE in pediatric patients younger than 4 months of age have not been established for the:

• Treatment of esophageal candidiasis
• Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation

What are the active and inactive ingredients in this medicine?

Active ingredient:

• MICAFUNGIN SODIUM

Inactive Ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured by:

• Astellas Pharma Tech Co., Ltd. Takaoka Plant
• 30 Toidesakae-machi, Takaoka city, Toyama , Japan

Marketed by:

• Astellas Pharma US, Inc.
• Northbrook, IL USA

• MYCAMINE® is a registered trademark of Astellas Pharma Inc.

What should I know about storage and disposal of this medication?

• Unopened vials of lyophilized material must be stored at room temperature, 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
• Store the reconstituted product at 25°C (77°F).
• Store the diluted solution at 25°C (77°F).,
• Protect from light.

• Dailymed label info on Micafungin
• FDA Micafungin

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