Micagin

Micafungin Sodium is indicated for:

• Treatment of Patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses: Micafungin has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections.
• Treatment of Patients with Esophageal Candidiasis.
• Prophylaxis of Candida Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation.

Do not mix or co-infuse micafungin with other medications. micafungin has been shown to precipitate when mixed directly with a number of other commonly used medications.

• 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.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Use in Patients with Renal Insufficiency: micafungin does not require dose adjustment in patients with renal impairment. Supplementary dosing should not be required following hemodialysis.

Use in Patients with Hepatic Insufficiency: Dose adjustment of micafungin is not required in patients with moderate hepatic impairment.

This is contraindicated in persons with known hypersensitivity to micafungin, any component of Mycamine, or other echinocandins.

Pregnancy Category C. There are no adequate and well-controlled studies of micafungin in pregnant women. Animal reproduction studies in rabbits showed visceral abnormalities and increased abortion at 4 times the recommended human dose. However, animal studies are not always predictive of human response. Micafungin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When pregnant rabbits were given 4 times the recommended human dose, there were increased abortion and visceral abnormalities including abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilatation of the ureter.

Nursing Mothers: It is not known whether micafungin is excreted in human milk. Caution should be exercised when Micafungin is administered to a nursing woman.

Hypersensitivity Reactions: Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving micafungin. If these reactions occur, micafungin infusion should be discontinued and appropriate treatment administered.

Hematological Effects: Acute intravascular hemolysis and hemoglobinuria was seen in a healthy volunteer during infusion of micafungin (200 mg) and oral prednisolone (20 mg). This reaction was transient, and the subject did not develop significant anemia. Isolated cases of significant hemolysis and hemolytic anemia have also been reported in patients treated with micafungin. Patients who develop clinical or laboratory evidence of hemolysis or hemolytic anemia during micafungin therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing micafungin therapy.

Hepatic Effects: Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with micafungin. In some patients with serious underlying conditions who were receiving micafungin along with multiple concomitant medications, clinical hepatic abnormalities have occurred, and isolated cases of significant hepatic dysfunction, hepatitis, and hepatic failure have been reported. Patients who develop abnormal liver function tests during micafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for the risk/benefit of continuing micafungin therapy.

Renal Effects: Elevations in BUN and creatinine, and isolated cases of significant renal dysfunction or acute renal failure have been reported in patients who received micafungin. In fluconazole-controlled trials, the incidence of drug-related renal adverse events was 0.4% for micafungin treated patients and 0.5% for fluconazole treated patients. Patients who develop abnormal renal function tests during micafungin therapy should be monitored for evidence of worsening renal function.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.