Amphotericin B Liposome For Injection Dosage/Direction for Use

Adult patients: Dosage of Amphotericin B Liposome for Injection must be adjusted to the specific requirements of each patient.
For treatment of systemic mycotic infections, therapy is usually instituted at a daily dose of 1.0 mg/kg of body weight, and increased stepwise to 3.0 mg/kg, as required. A cumulative dose of 1.0-3.0 g of Amphotericin B Liposome for Injection over 3-4 weeks has been typical.
Mucormycosis: Initiate treatment with 5 mg/kg administered daily. The duration of therapy should be determined on an individual basis. Courses of up to 56 days are commonly used in clinical practice; longer durations of therapy may be required for deep seated infections or in cases of prolonged courses of chemotherapy or neutropenia.
Doses greater than 5 mg/kg have been used in clinical trials and clinical practice. There are limited data on the safety and efficacy of Amphotericin B Liposome for Injection for the treatment of mucormycosis at these higher doses, therefore, a benefit-risk assessment should be made on an individual patient level to determine whether the potential benefits of treatment are considered to outweigh the known increased risk of toxicity at higher Amphotericin B Liposome for Injection doses.
For fever of unknown origin in neutropenic patients therapy should be initiated at 1.0 mg/kg/day; the dose may be raised to 3 mg/kg/day if indicated.
Visceral leishmaniasis: A dose of 1.0-1.5 mg/kg/day for 21 days or alternatively a dose of 3.0 mg/kg/day for 10 days can be used for treatment of visceral leishmaniasis. In immunocompromised patients (e.g. HIV positive), a dose of 1.0-1.5 mg/kg/day for 21 days may be used. Because of the risk of relapse, maintenance therapy or reinduction therapy may be necessary.
Paediatric population: Systemic fungal infections and fever of unknown origin have been successfully treated with Amphotericin B Liposome for Injection in paediatric patients, without reports of unusual adverse events. Amphotericin B Liposome for Injection has been reported in paediatric patients aged one month to 18 years old. Dosage should be calculated on the same per-kg body weight basis as for adults. The safety and efficacy of Amphotericin B Liposome for Injection has not been reported in infants under one month old.
Elderly population: No alteration in dose or frequency of dosing is required.
Renal impairment: Amphotericin B Liposome for Injection has been administered to patients with pre-existing renal impairment at doses of 1-5 mg/kg/day in reported clinical trials and no adjustment in dose or frequency of administration was required.
Hepatic impairment: No data are reported on which to make a dose recommendation for patients with hepatic impairment.
Method of administration: A test dose (1 mg) should be infused slowly for up to 10 minutes and the patient carefully observed for 30 minutes afterwards.
Amphotericin B Liposome for Injection should be administered by intravenous infusion over a 30-60 minute period. For doses greater than 5 mg/kg/day, intravenous infusion over a 2 hour period is recommended. The recommended concentration for intravenous infusion is 0.20 mg/ml to 2.00 mg/ml Amphotericin B Liposome for Injection.
For instructions on reconstitution and dilution of the product before administration, see Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product under Cautions for Usage.