Mycamine

Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections. 3 Posology Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s).

Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly. g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients ≤ 40 kg.

Treatment duration Invasive candidiasis:

The treatment duration of Candida infection should be a minimum of 14 days. The antifungal treatment 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.

Oesophageal candidiasis:

Micafungin should be administered for at least one week after resolution of clinical signs and symptoms.

Prophylaxis of Candida infections:

Micafungin should be administered for at least one week after neutrophil recovery. g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients weighing ≤ 40 kg.

Use in children (including neonates) < 4 months of age Indication Treatment of invasive candidiasis 4 -10 mg/kg/day* Prophylaxis of Candida infection 2 mg/kg/day *Micafungin dosed at 4 mg/kg in children less than 4 months approximates drug exposures achieved in adults receiving 100 mg/day for the treatment of invasive candidiasis.

g. 2).

Treatment duration Invasive candidiasis:

The treatment duration of Candida infection should be a minimum of 14 days. The antifungal treatment 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.

2% of the patients experienced adverse drug reactions. 3%). Tabulated list of adverse reactions In the following table 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.

4), acute renal failure 8 System Organ Class 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) General disorders and administration site conditions pyrexia, rigors injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema Investigations blood lactate dehydrogenase increased Description of selected adverse reactions Possible allergic-like symptoms Symptoms such as rash and rigors have been reported in clinical studies.

The majority were of mild to moderate intensity and not treatment limiting. g. g. advanced AIDS, malignancies) requiring multiple co-medications. 6% (260/3028). The majority of hepatic adverse reactions were mild and moderate. 5%). 4% serious) discontinued treatment due to a hepatic event.

4). Injection-site reactions None of the injection-site adverse reactions were treatment limiting. Paediatric population The incidence of some adverse reactions (listed in the table below) was higher in paediatric patients than in adult patients.

4). The most likely reason for these differences were different underlying conditions compared with adults or older paediatric patients observed in clinical studies. 7%, respectively). Blood and lymphatic system disorders common thrombocytopenia Cardiac disorders common tachycardia Vascular disorders common hypertension, hypotension Hepatobiliary disorders common hyperbilirubinaemia, hepatomegaly Renal and urinary disorders 9 common acute renal failure, blood urea increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Hepatic effects:

The development of foci of altered hepatocytes (FAH) and hepatocellular tumours after a treatment period of 3 months or longer were observed in rats. The assumed threshold for tumour development in rats is approximately in the range of clinical exposure.

The clinical relevance of this finding is not known. Liver function should be carefully monitored during micafungin treatment. To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended.

Micafungin treatment should be conducted on a careful risk/benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic and/or genotoxic properties.

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.

8). 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.

5 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.

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