PRESENTATION: A sterile powder for concentrate for dispersion for
infusion. Each vial contains 50mg of amphotericin B (50,000 units),
encapsulated in liposomes. Each vial contains 213 mg of
hydrogenated soy phosphatidylcholine, 900 mg of sucrose and a small
amount of sodium.
INDICATIONS (adults and children aged 1 month to 18 years): 1)
Systemic mycotic infections due to organisms susceptible to this anti-infective,
such as cryptococcosis, North American blastomycosis,
disseminated candidiasis, coccidioidomycosis, aspergillosis,
histoplasmosis, mucormycosis and in the treatment of some cases of
American mucocutaneous leishmaniasis. 2) Treatment of fever of
unknown origin in neutropenic patients, defined as persisting fever,
unresponsive to as least 96 hours of antibiotic treatment. 3) Primary
therapy of visceral leishmaniasis in both immunocompetent and
immunocompromised (e.g. HIV positive) patients. AmBisome should
not be used to treat the common clinically inapparent forms of fungal
disease which show only positive skin or serologic tests.
DOSAGE/ADMINISTRATION: Dosage must be adjusted to the
specific requirements of each patient. Preparation: Follow reconstitution
instructions exactly as given in the SmPC. Administration: A test dose (1
mg) should be infused slowly for up to 10 mins and the patient carefully
observed for 30 mins afterwards. AmBisome should be administered
by intravenous infusion over a 30 - 60 mins period or over a 2 hour
period for doses greater than 5 mg/kg/day. The recommended final
concentration is 0.2 mg/ml - 2.0 mg/ml. Posology: 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. A cumulative dose
of 1.0 – 3.0g over 3 – 4 weeks has been typical. Mucormycosis:
Initiate treatment with 5 mg/kg/daily. Duration of therapy should be
determined on an individual basis. Courses of up to 56 days are
commonly used in clinical practice. Longer durations may be required
for deep seated infections or prolonged courses of chemotherapy or
neutropenia. Doses greater than 5 mg/kg have been used in clinical
trials and clinical practice, however data on safety and efficacy are
limited. Therefore, a benefit:risk assessment should be made on an
individual patient level to determine whether the potential benefits are
considered to overweigh known risks of toxicity at these higher doses.
Fever of unknown origin in neutropenic patients: Therapy should be
initiated at 1.0 mg/kg/day and may be raised to 3 mg/kg/day if
indicated. Visceral leishmaniasis: 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. Children <1 month: Not recommended due to lack of data on
safety and efficacy. Elderly: No dose adjustment. Renal
Impairment: No dose adjustment unless clinically significant
reduction in renal function where consideration should be given to
dose reduction, treatment interruption or discontinuation. Hepatic
Impairment: No data available, no dose recommendation.
CONTRAINDICATIONS: Hypersensitivity to active ingredient/any
of the excipients unless the condition requiring treatment is life
threatening and amenable only to AmBisome therapy. AmBisome
contains soya oil. If you are allergic to peanut or soya, do not use
this medicinal product.
WARNINGS/PRECAUTIONS: Anaphylaxis and anaphylactoid
reactions: Test dose should be administered initially to detect
idiosyncratic anaphylactic reactions and minimise the dose
administered if a reaction occurs. If severe reaction occurs, infusion
should be immediately stopped and patient should not receive any
further infusion. Infusion-related reactions: Precautionary measures
are advisable. Slower infusion rates of over 2 hours or routine
administration of diphenhydramine, paracetamol, pethidine, and/or
hydrocortisone have been reported to be successful in their
prevention or treatment. Renal effects: Laboratory evaluation of
serum potassium and magnesium levels and renal, hepatic and
haematopoietic function should be performed, particularly in patients
receiving concomitant nephrotoxic drugs. Refer to SmPC for full
information on interactions with other medicines. Potassium
supplementation may also be required. If renal function deteriorates
significantly, consideration should be given to dosage reduction,
treatment interruption or discontinuation. Pulmonary Effects: Acute
pulmonary toxicity has been reported in patients given amphotericin B
(as sodium deoxycholate complex) during or shortly after leukocyte
transfusions. It is recommended that infusions are separated by as
long a period as possible and pulmonary function should be
monitored. Diabetic patients: Each vial contains approximately
900mg of sucrose. Renal dialysis patients: No dose adjustment is
required, however administration should be avoided during