Chemical formula: C₅₆H₇₁N₉O₂₃S Molecular mass: 1,270.274 g/mol PubChem compound: 477468
Micafungin interacts in the following cases:
There are currently insufficient data available for the use of micafungin in patients with severe hepatic impairment and its use is not recommended in these patients.
ticular toxicity was observed in animal studies. Micafungin may have the potential to affect male fertility in humans.
Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure. Since this may be of clinical significance this coadministration should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities.
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.
There are no data from the use of micafungin in pregnant women. In animal studies micafungin crossed the placental barrier and reproductive toxicity was seen. The potential risk for humans is unknown. Micafungin should not be used during pregnancy unless clearly necessary.
It is not known whether micafungin is excreted in human breast milk. Animal studies have shown excretion of micafungin in breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with micafungin should be made taking into account the benefit of breast-feeding to the child and the benefit of micafungin therapy to the mother.
Testicular toxicity was observed in animal studies. Micafungin may have the potential to affect male fertility in humans.
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.
Based on clinical trial experience, overall 32.2% of the patients experienced adverse drug reactions. The most frequently reported adverse reactions were nausea (2.8%), blood alkaline phosphatase increased (2.7%), phlebitis (2.5%, primarily in HIV infected patients with peripheral lines), vomiting (2.5%), and aspartate aminotransferase increased (2.3%).
In the following list adverse reactions are listed by system organ class and MedDRA preferred term. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: Common ≥1/100 to <1/10, Uncommon ≥1/1,000 to <1/100, Rare ≥1/10,000 to <1/1,000, Not known (frequency cannot be estimated from available data).
Common: leukopenia, neutropenia, anaemia
Uncommon: pancytopenia, thrombocytopenia, eosinophilia, hypoalbuminaemia
Rare: haemolytic anaemia, haemolytic anaemia, haemolysis
Not known: disseminated intravascular coagulation
Uncommon: anaphylactic/anaphylactoid reaction, hypersensitivity
Not known: anaphylactic and anaphylactoid shock
Uncommon: hyperhidrosis
Common: hypokalaemia, hypomagnesaemia, hypocalcaemia
Uncommon: hyponatraemia, hyperkalaemia, hypophosphataemia, anorexia
Uncommon: insomnia, anxiety, confusion
Common: headache
Uncommon: somnolence, tremor, dizziness, dysgeusia
Uncommon: tachycardia, palpitations, bradycardia
Common: phlebitis
Uncommon: hypotension, hypertension, flushing
Not known: shock
Uncommon: dyspnoea
Common: nausea, vomiting, diarrhoea, abdominal pain
Uncommon: dyspepsia, constipation
Common: blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased (including hyperbilirubinaemia), liver function test abnormal
Uncommon: hepatic failure, gammaglutamyltransferase increased, jaundice, cholestasis, hepatomegaly, hepatitis
Not known: hepatocellular damage including fatal cases
Common: rash
Uncommon: urticaria, pruritus, erythema
Not known: toxic skin eruption, erythema multiforme, StevensJohnson syndrome, toxic epidermal necrolysis
Uncommon: blood creatinine increased, blood urea increased, renal failure aggravated
Not known: renal impairment, acute renal failure
Common: pyrexia, rigors
Uncommon: injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema
Uncommon: blood lactate dehydrogenase increased
Symptoms such as rash and rigors have been reported in clinical studies. The majority were of mild to moderate intensity and not treatment limiting. Serious reactions (e.g. anaphylactoid reaction 0.2%, 6/3028) were uncommonly reported during therapy with micafungin and only in patients with serious underlying conditions (e.g. advanced AIDS, malignancies) requiring multiple co-medications.
The overall incidence of hepatic adverse reactions in the patients treated with micafungin in clinical studies was 8.6% (260/3028). The majority of hepatic adverse reactions were mild and moderate. Most frequent reactions were increase in AP (2.7%), AST (2.3%), ALT (2.0%), blood bilirubin (1.6%) and liver function test abnormal (1.5%). Few patients (1.1%; 0.4% serious) discontinued treatment due to a hepatic event. Cases of serious hepatic dysfunction occurred uncommonly.
None of the injection-site adverse reactions were treatment limiting.
The incidence of some adverse reactions (listed in the list below) was higher in paediatric patients than in adult patients. Additionally, paediatric patients <1 year of age experienced about two times more often an increase in ALT, AST and AP than older paediatric patients. The most likely reason for these differences were different underlying conditions compared with adults or older paediatric patients observed in clinical studies. At the time of entering the study, the proportion of paediatric patients with neutropenia was several-fold higher than in adult patients (40.2% and 7.3% of children and adults, respectively), as well as allogeneic HSCT (29.4% and 13.4%, respectively) and haematological malignancy (29.1% and 8.7%, respectively).
Common: thrombocytopenia
Common: tachycardia
Common: hypertension, hypotension
Common: hyperbilirubinaemia, hepatomegaly
Common: acute renal failure, blood urea increased
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