Micafungin

Micafungin in Sodium Chloride Injection is indicated 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.

Micafungin is a member of the echinocandin class of antifungal agents.

• If a dose of Micafungin in Sodium Chloride Injection is required that does not equal 50 mg, 100 mg, or 150 mg, this product is not recommended for use and an alternative formulation of micafungin should be considered. Recommended Dosage Administered by Indication, Weight and Age.

Micafungin in Sodium Chloride Injection is contraindicated in persons with known hypersensitivity to micafungin, any component of Micafungin in Sodium Chloride Injection, or other echinocandins. 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: Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria have been reported. Monitor rate of hemolysis. Discontinue if severe. • Hepatic Effects: Abnormalities in liver tests, isolated cases of hepatic impairment, hepatitis, and hepatic failure have been observed. 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 can occur including rash, pruritus, facial swelling, and vasodilatation.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions • Hematological Effects • Hepatic Effects • Renal Effects • Infusion and Injection Site Reactions • High Sodium Load • 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.

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

Store Micafungin in Sodium Chloride Injection in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. If needed, Micafungin in Sodium Chloride Injection may be stored at room temperature 20°C to 25°C (68°F to 77°F) for up to 30 days in the original carton to protect from light. Once stored at room temperature, do not place back in the refrigerator. Discard Micafungin in Sodium Chloride Injection after 30 days if stored at room temperature. Do not freeze and do not use Micafungin in Sodium Chloride Injection if it has been frozen.