NIKP Micafungin For Injection

Invasive candidiasis & prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or who are expected to have neutropenia (ANC <500 cells/μL) for ≥10 days in adults, elderly, adolescents & childn including infants. Oesophageal candidiasis in patients for whom IV therapy is appropriate in adults, adolescents ≥16 yr & elderly.

IV Administer by infusion over approx 1 hr. Adult, adolescent ≥16 yr & elderly Invasive candidiasis Weighing >40 kg 100 mg daily & may be increased to 200 mg daily if patient's response is inadequate, ≤40 kg 2 mg/kg daily & may be increased to 4 mg/kg daily if patient's response is inadequate. Treatment duration: Min of 14 days. Continue for at least 1 wk after 2 sequential -ve blood cultures, Oesophageal candidiasis Weighing >40 kg 150 mg daily, ≤40 kg 3 mg/kg daily. Treatment duration: At least 1 wk after resolution of clinical signs & symptoms of infection. Prophylaxis of Candida infection Weighing >40 kg 50 mg daily, ≤40 kg 1 mg/kg daily. Treatment duration: At least 1 wk after neutrophil recovery. Adolescent <16 yr & childn ≥4 mth Invasive candidiasis Weighing >40 kg 100 mg daily, ≤40 kg 2 mg/kg daily. Prophylaxis of Candida infection Weighing >40 kg 50 mg daily, ≤40 kg 1 mg/kg daily. Childn (including neonates) <4 mth Invasive candidiasis 4-10 mg/kg daily. Treatment duration: Min of 14 days. Continue for at least 1 wk after 2 sequential -ve blood cultures & after resolution of clinical signs & symptoms of infection. Prophylaxis of Candida infection 2 mg/kg daily. Treatment duration: At least 1 wk after neutrophil recovery.

Hypersensitivity to micafungin or other echinocandins.

Discontinue use if anaphylactic/anaphylactoid reactions including shock occur; lesions progress. Exfoliative cutaneous reactions eg, SJS & TEN. Early treatment discontinuation in the presence of significant & persistent elevation of ALT/AST. Haemolysis including acute intravascular haemolysis or haemolytic anaemia. Dizziness. Patients receiving concomitant therapy including hepatotoxic &/or genotoxic properties. Carefully monitor liver function during treatment. Closely monitor patients who develop clinical or lab evidence of haemolysis during therapy for evidence of worsening; worsening of renal function. Concomitant use w/ amphotericin B desoxycholate; sirolimus, nifedipine or itraconazole. Contains Na 23 mg/dose. Not recommended in severe hepatic impairment. Chronic liver diseases known to represent preneoplastic conditions eg, advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects. Kidney problems, renal failure & abnormal renal function test. Potential to affect male fertility. Not to be used during pregnancy. Lactation. Paed <1 yr (more prone to liver injury). Childn (including neonates) <4 mth for treatment of invasive candidiasis w/ CNS involvement.

Leukopenia, neutropenia, anaemia; hypokalaemia, hypomagnesaemia, hypocalcaemia; headache; phlebitis; nausea, vomiting, diarrhoea, abdominal pain; increased blood alkaline phosphatase & bilirubin (including hyperbilirubinaemia), AST & ALT, abnormal LFT; rash; pyrexia, rigors. Erythema multiforme, SJS, TEN. Paed: Thrombocytopenia; tachycardia; HTN, hypotension; hepatomegaly; acute renal failure, increased blood urea.

Slightly increased exposure of itraconazole, sirolimus, nifedipine; amphotericin B desoxycholate.

Antifungals

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

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