NIKP Micafungin For Injection Special Precautions

Micafungin treatment was associated with significant impairment of liver function (increase of ALT, AST or total bilirubin >3 times ULN) in both healthy volunteers and patients. In some patients more severe hepatic dysfunction, hepatitis, or hepatic failure including fatal cases have been reported. Paediatric patients < 1 year of age might be more prone to liver injury (see Adverse Reactions).
Anaphylactic reactions: During administration of micafungin, anaphylactic/anaphylactoid reactions, including shock, may occur. If these reactions occur, micafungin infusion should be discontinued and appropriate treatment administered.
Skin reactions: 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 micafungin discontinued if lesions progress.
Haemolysis: Rare 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 micafungin therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing micafungin therapy.
Renal effects: Micafungin may cause kidney problems, renal failure, and abnormal renal function test. Patients should be closely monitored for worsening of renal function.
Interactions with other medicinal products: Co-administration of micafungin and amphotericin B desoxycholate should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see Interactions).
Patients receiving sirolimus, nifedipine or itraconazole in combination with micafungin should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary (see Interactions).
Excipients: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: Micafungin has no or negligible influence on the ability to drive or use machines. However, patients should be informed that dizziness has been reported during treatment with micafungin (see Adverse Reactions).
Use in Children: The incidence of some adverse reactions was higher in paediatric patients than in adult patients (see Adverse Reactions).