Mycamine

Micafungin Na

Invasive candidiasis in adult & childn. Adults, adolescents ≥16 yr & elderly w/ esophageal candidiasis in whom IV therapy is appropriate; aspergillosis. Prophylaxis of Candida & Aspergillus infections in patients undergoing allogeneic hematopoietic stem cell transplantation or patients expected to have neutropenia (ANC <500 cells/microL) for ≥10 days.

IV infusion Administered over 1 hr. Invasive candidiasis Adult, adolescent, childn ≥4 mth & elderly weighing >40 kg 100 mg daily, may be increased to 200 mg daily, ≤40 kg 2 mg/kg daily, may be increased to 4 mg/kg daily. Childn <4 mth including neonates 4-10 mg/kg daily. Treatment duration: Min of 14 days & continued for at least 1 wk after 2 sequential -ve blood cultures & resolution of infection. Esophageal candidiasis Adult, adolescent ≥16 yr & elderly weighing >40 kg 150 mg daily, ≤40 kg 3 mg/kg daily. Treatment duration: At least 1 wk after resolution of signs & symptoms. Aspergillosis Adult, adolescent ≥16 yr & elderly weighing >40 kg 100-150 mg daily, may be increased up to 300 mg daily for severe or refractory aspergillosis, ≤40 kg 2-3 mg/kg daily. Prophylaxis of Candida & Aspergillus infection Adult, adolescent ≥16 yr & elderly weighing >40 kg 50 mg daily, ≤40 kg 1 mg/kg daily. Treatment duration: At least 1 wk after neutrophil recovery. Prophylaxis of Candida infection Childn ≥4 mth to adolescent <16 yr weighing >40 kg 50 mg daily, ≤40 kg 1 mg/kg daily, <4 mth including neonates 2 mg/kg daily. Treatment duration: At least 1 wk after neutrophil recovery.

Hypersensitivity to micafungin or other echinocandins.

Discontinue in the presence of significant & persistent ALT/AST elevation; if anaphylactic/anaphylactoid reactions including shock occur; if patient develops a lesion that progress. Increased ALT, AST or total bilirubin; hepatitis, hepatic failure including fatal cases. Exfoliative cutaneous reactions eg, SJS & TEN. May cause kidney problems, renal failure & abnormal renal function test. Closely monitor liver function during treatment; if patients develop rash; for worsening hemolysis (eg, acute intravascular hemolysis or hemolytic anemia) & renal function during treatment. Carefully monitor liver function during treatment. Concomitant use w/ amphotericin B desoxycholate; sirolimus, nifedipine or itraconazole. Severe liver function impairment or chronic liver diseases known to represent pre-neoplastic conditions eg, advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic &/or genotoxic properties. May influence ability to drive & use machines. May affect male fertility. Not to be used during pregnancy. Lactation. Higher incidence of adverse reactions in ped patients. Ped patients <1 yr may be more prone to liver injury. Childn <2 yr w/ Candida infection.

Leukopenia, neutropenia, anemia; hypokalemia, hypomagnesemia, hypocalcemia; headache; phlebitis; nausea, vomiting, diarrhea, abdominal pain; increased blood alkaline phosphatase, AST, ALT & blood bilirubin including hyperbilirubinemia, abnormal LFT; rash; pyrexia, rigors. SJS, TEN. Ped patient: Thrombocytopenia; tachycardia; HTN, hypotension; hepatomegaly; acute renal failure, increased blood urea.

Slightly increased AUC of itraconazole, sirolimus & nifedipine. Increased exposure of amphotericin B desoxycholate.

Antifungals

J02AX05 - micafungin ; Belongs to the class of other systemic antimycotics.

D