MICAFUNGIN 100 mg ACCORD

Indications

• Invasive candidiasis
• Esophageal candidiasis
• Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation

Dosage

Children: For neonates, the recommended dose is 2 mg/kg once daily for at least 14 days, with adjustments based on clinical response and expert advice.

Adults: For the treatment of invasive candidiasis, the typical adult dose is 100 mg administered intravenously once daily. The duration of therapy should be determined by the clinical response, and may require adjustment based on renal and hepatic function.

Mechanism of action

Micafungin inhibits the synthesis of beta-1,3-D-glucan, an essential component of fungal cell walls which is not present in mammalian cells. It achieves this by inhibiting the enzyme beta-1,3-D-glucan synthase.

Pharmacodynamics

Micafungin is a glucan synthesis inhibitor of the echinocandin structural class, known for its antifungal properties. Depending on its concentration, micafungin may exhibit fungicidal effects against some Candida species, while it is generally fungistatic against Aspergillus species. It was approved by the U.S. FDA in March 2005 and can be used alongside various medications, including HIV protease inhibitors and immunosuppressants.

Pharmacokinetics

Micafungin is administered intravenously and has a steady-state volume of distribution of approximately 0.3 L/kg. It is predominantly metabolized in the liver and has a half-life of about 11 to 17 hours. The clearance of micafungin can be affected by hepatic function, and renal function may also influence its pharmacokinetic profile. Monitoring of liver and renal function is recommended during treatment.

Adverse effects

• hyperbilirubinaemia
• hyperglycaemia
• hypertension
• drowsiness
• dysnoea
• electrolyte imbalance
• hypotension
• hypoxia
• induration
• insomnia
• laryngeal eosinophilia
• flushing
• gastrointestinal discomfort
• pain
• leucopenia
• malaise
• metabolic acidosis
• muscle haemolysis
• haemolytic anaemia
• headache
• hepatic weakness
• myalgia
• nasal congestion
• oedema
• renal impairment
• respiratory disorders
• hyperhidrosis
• hypersensitivity
• abnormal taste
• altered thrombocytopenia
• tremor
• blurred vision
• nausea
• neutropenia
• palpitations

Interactions

• micafungin + amphotericin: unknown (increases exposure)

Precautions

• Use with caution in patients with hepatic impairment; avoid in severe impairment.
• Monitor renal function as renal function may deteriorate.
• Monitor liver function and discontinue if significant and persistent abnormalities in liver function tests develop.

Pregnancy

Manufacturer advises to avoid unless essential, due to toxicity in animal studies.

Breast-feeding

Present in milk in animal studies; manufacturer advises use only if potential benefit outweighs risk.

Storage

Store in a cool, dry place. Protect from light.

Formulations

• {'name': 'Micafungin 50 mg', 'form': 'Powder for solution for infusion'}
• {'name': 'Micafungin 100 mg', 'form': 'Powder for solution for infusion'}

Mechanism of action

Micafungin inhibits the synthesis of beta-1,3-D-glucan, an essential component of fungal cell walls which is not present in mammalian cells. It does this by inhibiting beta-1,3-D-glucan synthase.

Pharmacodynamics

Formerly known as FK463, micafungin is a semisynthetic lipopeptide synthesized from a fermentation product of <i>Coleophoma empetri</i> that works as an antifungal agent. It is a glucan synthesis inhibitor of the echinocandin structural class. The U.S. Food and Drug Administration approved micafungin in March 2005. Micafungin inhibits an enzyme essential for fungal cell-wall synthesis. Depending on its concentration, micafungin may be fungicidal against some <i>Candida</i>, but is usually fungistatic against <i>Apergillus</i>. Micafungin can be used concomitantly with a variety of other drugs, including the HIV protease inhibitor ritonavir and the transplant medications cyclosporine and tacrolimus.