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Polyene Antifungal — Invasive Fungal Infections (Aspergillosis / Cryptococcosis / Candida) Pregnancy: eMC §4.6: safety in pregnant women has not been established. Systemic fungal infections have been successfully treated in pregnant women with conventional amphotericin B without obvious effect on the fetus, but the number of cases reported is insufficient to draw conclusions about the liposomal product. It should only be used during pregnancy if the possible benefits outweigh the potential risks to mother and fetus. It is unknown whether it is excreted in human breast milk - weigh the potential risk to the child against the benefits of breast-feeding and of therapy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Amphotericin B (Liposomal)

Brand names: AmBisome

Liposomal amphotericin B is a lipid-formulated polyene antifungal used for severe systemic fungal infections and visceral leishmaniasis, where the liposomal carrier reduces toxicity compared with the conventional formulation.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 3 to 5 mg/kg body weight per day (treatment of mycoses; therapy is usually instituted at this daily dose for a minimum of 14 days)
Route: Intravenous infusion over 30 to 60 minutes; for doses greater than 5 mg/kg/day, infusion over 2 hours is recommended. Recommended infusion concentration 0.20 mg/mL to 2.00 mg/mL amphotericin B.
Frequency: Once daily
Max: eMC §4.2 (mucormycosis): doses greater than 5 mg/kg and up to a maximum of 10 mg/kg have been used in clinical trials and practice, but data on safety and efficacy at these higher doses are limited - make an individual benefit:risk assessment against the known increased toxicity at higher doses
eMC §4.2 (Amphotericin B Gilead liposomal 50 mg powder for dispersion for infusion, previously AmBisome). NON-EQUIVALENCE: different amphotericin products (sodium deoxycholate, liposomal, lipid complex) are NOT equivalent in pharmacodynamics, pharmacokinetics or dosing and must not be used interchangeably; verify the trade name, common name and dose before administration - there is a risk of under-dose if the liposomal product is given at a dose recommended for amphotericin B deoxycholate. Anaphylaxis and anaphylactoid reactions can occur at any point of treatment, so monitor the patient closely during every infusion. INDICATION-SPECIFIC DOSING: treatment of mycoses 3 to 5 mg/kg/day for a minimum of 14 days, adjusted to the specific requirements of each patient. MUCORMYCOSIS - recommended starting dose 5 to 10 mg/kg/day for suspected or confirmed infection; dose at 10 mg/kg/day in patients with brain involvement or solid-organ transplant; avoid slow escalation of doses; duration determined individually, with courses of up to 6-8 weeks commonly used and longer durations sometimes required for deep-seated infection or prolonged chemotherapy/neutropenia. HIV-ASSOCIATED CRYPTOCOCCAL MENINGITIS - a single dose of 10 mg/kg on day 1, in combination with daily flucytosine 100 mg/kg and daily fluconazole 1200 mg, both given for 14 days; after the 2-week induction period, fluconazole 800 mg daily for 8 weeks and then 200 mg daily thereafter at the treating physician's discretion. VISCERAL LEISHMANIASIS - a total dose of 21.0 to 30.0 mg/kg body weight given over 10-21 days; administer under strict medical supervision (data on optimal dosage and development of resistance are incomplete). EMPIRICAL TREATMENT OF FEBRILE NEUTROPENIA - 3 to 5 mg/kg/day, continued until the recorded temperature has been normal for 3 consecutive days; discontinue after a maximum of 42 days in any event. PAEDIATRIC (SPC does not give a separate paediatric number, so no structured paediatric dose is recorded here): both systemic fungal infections and presumed fungal infections in children with febrile neutropenia have been successfully treated, without reports of unusual adverse events; the product has been studied in paediatric patients aged one month to 18 years and the doses used in those studies were the same as those used in adults on a mg/kg body weight basis. NOT recommended in children below 1 month old due to lack of safety and efficacy data. Verify paediatric use against a children's formulary. ELDERLY: no alteration in dose or frequency of dosing is required. HEPATIC IMPAIRMENT: no data are available on which to make a dose recommendation. US labelling (Sun Pharmaceutical, 2026-04-20) differs and quotes initial doses of 3 mg/kg/day for empirical therapy, 3 to 5 mg/kg/day for systemic Aspergillus, Candida or Cryptococcus infection and 6 mg/kg/day for cryptococcal meningitis in HIV-infected patients, with visceral leishmaniasis 3 mg/kg/day on days 1-5 plus days 14 and 21 (immunocompetent) or 4 mg/kg/day on days 1-5 plus days 10, 17, 24, 31 and 38 (immunocompromised), infused over approximately 120 minutes (reducible to about 60 minutes if well tolerated) - use the UK SPC figures above unless local policy states otherwise.

Dose adjustments

Renal

eMC §4.2: the product has been administered to a large number of patients with pre-existing renal impairment at starting doses ranging from 1-3 mg/kg/day in clinical trials, and no adjustment in dose or frequency of administration was required. §4.4: renal adverse reactions may still occur - incidence rates of increased serum creatinine, hypokalaemia and hypomagnesaemia were notably higher with 5, 6 or 10 mg/kg daily than with 3 mg/kg daily. Monitor serum electrolytes (particularly potassium and magnesium) and renal, hepatic and haematopoietic function at least once weekly; potassium supplementation may be required, and hyperkalaemia (some cases leading to arrhythmia and cardiac arrest) has been reported. If clinically significant reduction in renal function or worsening of other parameters occurs, consider dose reduction, treatment interruption or discontinuation.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients, unless in the opinion of the physician the condition requiring treatment is life-threatening and amenable only to this therapy (eMC §4.3)

Side effects

  • Very common: hypokalaemia; rigors and pyrexia; nausea and vomiting
  • Infusion-related reactions - fever and chills/rigors are the most frequent; less frequently chest tightness or pain, dyspnoea, bronchospasm, flushing, tachycardia, hypotension and musculoskeletal pain. These resolve rapidly on stopping the infusion and may be prevented by slower (2-hour) infusion or premedication
  • Common: hyponatraemia, hypocalcaemia, hypomagnesaemia, hyperglycaemia, hyperkalaemia; increased creatinine and increased blood urea
  • Common: hypotension, vasodilatation, flushing, tachycardia, dyspnoea, headache, diarrhoea, abdominal pain, rash, back pain, chest pain, abnormal liver function tests, hyperbilirubinaemia, increased alkaline phosphatase
  • Uncommon: thrombocytopenia, anaphylactoid reaction, convulsion, bronchospasm. Not known: anaphylactic reactions, hypersensitivity, cardiac arrest, arrhythmia, renal failure/renal insufficiency, angioneurotic oedema, rhabdomyolysis (associated with hypokalaemia)

Interactions

  • Antineoplastic agents (US labelling) - concurrent use may enhance the potential for renal toxicity, bronchospasm and hypotension; give concomitantly with caution
  • Corticosteroids and corticotropin (ACTH) (US labelling) - may potentiate hypokalaemia and predispose to cardiac dysfunction; monitor serum electrolytes and cardiac function closely
  • Digitalis glycosides (US labelling) - induced hypokalaemia may potentiate digitalis toxicity; monitor serum potassium closely
  • Flucytosine (US labelling) - concurrent use may increase flucytosine toxicity by increasing its cellular uptake and/or impairing its renal excretion
  • Azoles such as ketoconazole, miconazole, clotrimazole and fluconazole (US labelling) - animal and in vitro data suggest imidazoles may induce fungal resistance to amphotericin B; combination therapy should be given with caution, especially in immunocompromised patients
  • The eMC §4.5 interaction section was not captured in this bundle - clinician to review it in the SPC

Clinical monograph

How it works

Amphotericin B binds ergosterol in the fungal cell membrane, forming pores that increase permeability and cause cell death; encapsulation in liposomes alters tissue distribution and lessens host-cell toxicity.

Prescribing in practice

  • Lipid and conventional amphotericin formulations are not interchangeable and differ substantially in dosing, so prescriptions must clearly specify the liposomal product to avoid potentially fatal dosing errors.
  • Although better tolerated than the conventional form, it still causes dose-related nephrotoxicity and electrolyte disturbances, particularly hypokalaemia and hypomagnesaemia, requiring monitoring and replacement.
  • Infusion-related reactions such as fever, rigors and chills can occur and may require supportive measures or rate adjustment.

Monitoring

Monitor renal function, serum potassium and magnesium, and full blood count regularly, and observe for infusion reactions.

Counselling the patient

  • Tell staff if you develop fever, chills or shivering during the infusion.
  • Regular blood tests are needed to check your kidneys and salts.
  • Report muscle weakness or cramps, which may reflect low potassium or magnesium.

Evidence & guidelines

Liposomal amphotericin B is recommended in UK and international guidance for invasive fungal infections and as a first-line option for visceral leishmaniasis, offering reduced nephrotoxicity relative to the conventional formulation.

Reference: ECMM/ISHAM Cryptococcal Meningitis Guidelines; ESCMID/ECMM Aspergillosis Guidelines; WHO HIV/Cryptococcosis Guidelines 2022; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.