Posology : מינונים

4.2     Posology and method of administration

Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections.


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.

The dose regimen of micafungin depends on the body weight of the patient as given in the following tables:

Use in adults, adolescents ≥ 16 years of age and elderly

Indication
Body weight > 40 kg          Body weight ≤ 40 kg
Treatment of invasive candidiasis                                100 mg/day*                  2 mg/kg/day* Treatment of oesophageal candidiasis                             150 mg/day                   3 mg/kg/day Prophylaxis of Candida infection                                 50 mg/day                    1 mg/kg/day *If the patient’s response is inadequate, e.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.

Use in children ≥ 4 months of age up to adolescents < 16 years of age 
Indication
Body weight > 40 kg          Body weight ≤ 40 kg
Treatment of invasive candidiasis                                100 mg/day*                  2 mg/kg/day* Prophylaxis of Candida infection                                 50 mg/day                    1 mg/kg/day *If the patient’s response is inadequate, e.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. If central nervous system (CNS) infection is suspected, a higher dosage (e.g. 10 mg/kg) should be used due to the dose-dependent penetration of micafungin into the CNS (see section 5.2).

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.

Prophylaxis of Candida infections: micafungin should be administered for at least one week after neutrophil recovery. Experience with Mycamine in patients less than 2 years of age is limited.
Hepatic impairment
No dose adjustment is necessary in patients with mild or moderate hepatic impairment (see section 5.2). 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 (see section 4.4 and 5.2).

Renal impairment
No dose adjustment is necessary in patients with renal impairment (see section 5.2).

Paediatric population
The safety and efficacy in children (including neonates) less than 4 months of age of doses of 4 and 10 mg/kg for the treatment of invasive candidiasis with CNS involvement has not been adequately established. Currently available data are described in section 4.8, 5.1, 5.2.

Method of administration
For intravenous use.
After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour. More rapid infusions may result in more frequent histamine mediated reactions.
For reconstitution instructions see section 6.6.