MYCAMINE Powder for solution for infusion Ref.[8447] Active ingredients: Micafungin

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:

* 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:

* 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:

* 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 sections 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.

Repeated daily doses up to 8 mg/kg (maximum total dose 896 mg) in adult patients have been administered in clinical trials with no reported dose-limiting toxicity. In one spontaneous case, it was reported a dosage of 16 mg/kg/day was administered in a newborn patient. No adverse reactions associated with this high dose were noted.

There is no experience with overdoses of micafungin. In case of overdose, general supportive measures and symptomatic treatment should be administered. Micafungin is highly protein-bound and not dialysable.

Unopened vial: 3 years.

Reconstituted concentrate in vial

Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C when reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.

Diluted infusion solution

Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.

Mycamine contains no preservatives. From a microbiological point of view, the reconstituted and diluted solutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the reconstitution and dilution have taken place in controlled and validated aseptic conditions.

Unopened vials: This medicinal product does not require any special storage conditions.

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

10 ml Type I glass vial with an isobutylene-isoprene (PTFE-laminated) rubber stopper and a flip-off cap. The vial is wrapped with an UV-protective film.

Pack size: packs of 1 vial.

Any unused product or waste material should be disposed of in accordance with local requirements.

Mycamine must not be mixed or co-infused with other medicinal products except those mentioned below. Using aseptic techniques at room temperature, Mycamine is reconstituted and diluted as follows:

1. The plastic cap must be removed from the vial and the stopper disinfected with alcohol.
2. Five ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be aseptically and slowly injected into each vial along the side of the inner wall. Although the concentrate will foam, every effort should be made to minimise the amount of foam generated. A sufficient number of vials of Mycamine must be reconstituted to obtain the required dose in mg (see table below).
3. The vial should be rotated gently. DO NOT SHAKE. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use only. Therefore, unused reconstituted concentrate must be discarded immediately.
4. All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken. The diluted infusion solution should be used immediately. Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light and diluted as described above.
5. The infusion bottle/bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming. The solution must not be used if it is cloudy or has precipitated.
6. The infusion bottle/bag containing the diluted infusion solution should be inserted into a closable opaque bag for protection from light.

Preparation of the solution for infusion:

After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.