MYCAMINE

What it is

MYCAMINE is a powder for injection available in two strengths: 50 mg and 100 mg, containing micafungin sodium. The powder must be diluted with either sodium chloride 0.9% or glucose 5% solution prior to use. Micafungin is a member of the echinocandin lipopeptide family and non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls which is not present in mammalian cells. Micafungin exhibits fungicidal activity against most Candida species and inhibits actively growing hyphae of Aspergillus species.

Approved indications

— Treatment of invasive candidiasis in children and adults — Treatment of oesophageal candidiasis in adults, adolescents ≥ 16 years of age and elderly patients for whom intravenous therapy is appropriate — Prophylaxis of Candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/μL) for 10 or more days

Dosing overview

MYCAMINE should be administered once daily by intravenous infusion. The dosage depends on the indication and body weight of the patient. If the patient's response is inadequate, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients weighing ≤ 40 kg. For invasive candidiasis, treatment duration should be a minimum of 14 days and should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection. For oesophageal candidiasis, MYCAMINE should be administered for at least one week after resolution of clinical signs and symptoms. For prophylaxis of Candida infection, MYCAMINE should be administered for at least one week after neutrophil recovery.

Key safety warnings

During administration of MYCAMINE, anaphylactic and anaphylactoid reactions including shock may occur. If these reactions occur, MYCAMINE should be discontinued and appropriate treatment administered. Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. If patients develop a rash they should be monitored closely and MYCAMINE discontinued if lesions progress. Isolated cases of haemolysis including acute intravascular haemolysis or haemolytic anaemia have been reported in patients treated with micafungin. Patients who develop clinical or laboratory evidence of haemolysis during MYCAMINE therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk and benefit of continuing therapy. Liver function should be carefully monitored during MYCAMINE treatment. Early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended. MYCAMINE treatment should be conducted on a careful risk and benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent pre-neoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving concomitant therapy including hepatotoxic or genotoxic properties.

Contraindications

MYCAMINE is contraindicated in patients with hypersensitivity to any component of this medication or to other echinocandins.

Regulatory history

MYCAMINE micafungin 50 mg and 100 mg powder for injection were first listed on the ARTG on 8 May 2013. The AusPAR approval date was 2 May 2013 for treatment of invasive candidiasis in children and adults, treatment of oesophageal candidiasis in adults and adolescents, and prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or those with expected neutropenia. The TGA approved MYCAMINE for registration after all quality and nonclinical concerns were satisfactorily addressed, with the product officially registered on 8 May 2013.