Micafungin in 0.9% Sodium Chloride Injection

Micafungin in 0.9% Sodium Chloride Injection

Indications and Important Risk Information

Indications

• Micafungin in Sodium Chloride Injection is an echinocandin indicated 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 for whom appropriate dosing with this formulation can be achieved.
  • 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 for whom appropriate dosing with this formulation can be achieved.
  • Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older for whom appropriate dosing with this formulation can be achieved.
  • Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT) for whom appropriate dosing with this formulation can be achieved.
• Limitations of Use:
  • The safety and effectiveness of Micafungin in Sodium Chloride Injection 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.
  • Micafungin in Sodium Chloride Injection has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida.
  • The efficacy of Micafungin in Sodium Chloride Injection against infections caused by fungi other than Candida has not been established.

Important Risk Information

• Contraindications: Micafungin in Sodium Chloride Injection is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of Micafungin in Sodium Chloride Injection, or other echinocandins.
• Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue Micafungin in Sodium Chloride Injection and administer appropriate treatment.
• Hematological Effects: Acute intravascular hemolysis and hemoglobinuria was seen in a healthy volunteer during infusion of Micafungin for Injection (200 mg) and oral prednisolone (20 mg). Cases of significant hemolysis and hemolytic anemia have also been reported in patients treated with Micafungin for Injection. Patients who develop clinical or laboratory evidence of hemolysis or hemolytic anemia during therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing 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 impairment, hepatitis, and hepatic failure have been reported. Monitor hepatic function. Discontinue if severe dysfunction occurs.
• Renal Effects: Elevations in BUN and creatinine; isolated cases of renal impairment or acute renal failure have been reported. Monitor renal function.
• Infusion and Injection Site Reactions: Possible histamine-mediated symptoms have been reported with Micafungin for Injection, including rash, pruritus, facial swelling, and vasodilatation. Slow the infusion rate if infusion reaction occurs. Injection site reactions, including phlebitis and thrombophlebitis have been reported, at Micafungin for Injection doses of 50 to 150 mg/day. These reactions tended to occur more often in patients receiving Micafungin for Injection via peripheral intravenous administration.
• High Sodium Load: Each 50, 100, and 150 mL Galaxy container contains 200, 400, and 600 mg of sodium, respectively. Avoid use in patients with congestive heart failure, elderly patients, and patients requiring restricted sodium intake.
• Adverse Reactions:
  • Most common adverse reactions across adult and pediatric clinical trials for all indications include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache.
  • In pediatric patients younger than 4 months of age, the following additional common adverse reactions were reported at an incidence rate of ≥15%: hypokalemia, acidosis, sepsis, anemia, and oxygen saturation decreased.
• Drug Interactions:
  • Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary.
  • Pregnancy: Based on animal data, Micafungin in Sodium Chloride Injection may cause fetal harm. Advise pregnant women of the risk to the fetus.

Please see accompanying full Prescribing Information for Micafungin in 0.9% Sodium Chloride Injection.

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