Drug Monograph

AmBisome (Amphotericin B Liposomal)

amphotericin B liposomal injection

Polyene Antifungal · Intravenous · Liposomal Formulation
Pharmacokinetic Profile
Half-Life
7–10 h (initial); 100–153 h (terminal)
Metabolism
Unknown; not CYP-mediated
Protein Binding
>90% (amphotericin B)
Bioavailability
IV only (100%)
Volume of Distribution
0.10–0.44 L/kg (dose-dependent)
Clinical Information
Drug Class
Polyene antifungal (liposomal)
Available Doses
50 mg/vial lyophilized powder
Route
Intravenous infusion
Renal Adjustment
No dose adjustment; monitor closely
Hepatic Adjustment
Not studied; use with caution
Pregnancy
Use only if benefit outweighs risk
Lactation
Unknown excretion; probably compatible
Schedule / Legal Status
Rx only (not scheduled)
Generic Available
No (brand only)
Therapeutic Index
Narrow (nephrotoxicity dose-limiting)
Rx

Indications for Amphotericin B Liposomal

IndicationApproved PopulationTherapy TypeStatus
Empirical therapy for presumed fungal infection in febrile neutropeniaAdults and pediatrics (≥1 month)MonotherapyFDA Approved
Cryptococcal meningitis in HIV-infected patientsAdultsInduction monotherapy (followed by fluconazole consolidation)FDA Approved
Invasive aspergillosis, candidiasis, or cryptococcosis refractory to conventional amphotericin BAdults and pediatricsMonotherapy or salvageFDA Approved
Invasive fungal infection when conventional amphotericin B is contraindicated by renal impairment or toxicityAdults and pediatricsAlternative monotherapyFDA Approved
Visceral leishmaniasis (immunocompetent patients)Adults and pediatricsMonotherapyFDA Approved
Visceral leishmaniasis (immunocompromised patients)AdultsMonotherapy (high relapse rate)FDA Approved

Amphotericin B liposomal occupies a central role in the management of life-threatening systemic fungal infections, particularly in immunocompromised hosts. The liposomal formulation delivers high tissue concentrations to organs of the reticuloendothelial system while substantially reducing the nephrotoxicity and infusion-related reactions that limit conventional amphotericin B deoxycholate. It is regarded as the preferred amphotericin B formulation in most clinical contexts where a polyene agent is warranted (FDA PI).

Off-Label Uses

Mucormycosis (zygomycosis) — first-line therapy: High-dose amphotericin B liposomal (5–10 mg/kg/day) is the cornerstone of pharmacotherapy for mucormycosis. The ECMM/MSG 2019 global guideline and ESCMID 2013 guideline both strongly recommend liposomal amphotericin B as first-line treatment, combined with surgical debridement when feasible. Evidence quality: Moderate

Invasive aspergillosis — alternative first-line or salvage: When voriconazole is contraindicated or not tolerated, the IDSA 2016 guideline recommends liposomal amphotericin B (3–5 mg/kg/day) as the preferred alternative agent for invasive pulmonary aspergillosis. Evidence quality: Moderate

Invasive candidiasis in pregnancy: Amphotericin B (preferably the liposomal formulation) is regarded by the IDSA as the antifungal of choice for invasive candidiasis during pregnancy, given the teratogenic potential of azole antifungals. Evidence quality: Low

Histoplasmosis — moderate-to-severe disseminated disease: IDSA guidelines recommend liposomal amphotericin B 3 mg/kg/day as induction therapy for 1–2 weeks, followed by oral itraconazole step-down. Evidence quality: Moderate

Dose

Dosing of Amphotericin B Liposomal

Adult and Pediatric Dosing by Clinical Scenario

Clinical ScenarioStarting DoseMaintenance DoseMaximum DoseNotes
Febrile neutropenia — empirical antifungal therapy3 mg/kg IV once daily3 mg/kg IV once daily5 mg/kg/dayContinue until neutropenia resolves and fever abates for ≥4 days, or proven fungal infection treated
Infuse over ~2 hours; may shorten to 1 hour if tolerated (FDA PI)
Cryptococcal meningitis — HIV-associated, induction6 mg/kg IV once daily6 mg/kg IV once daily6 mg/kg/dayInduction for 11–21 days, then transition to oral fluconazole 400 mg/day consolidation
3 mg/kg was not shown comparable to conventional amphotericin B at 10-week outcomes (FDA PI)
Invasive aspergillosis, candidiasis, or cryptococcosis — refractory or intolerant to conventional amphotericin B3 mg/kg IV once daily3–5 mg/kg IV once daily5 mg/kg/dayTreat until clinical and mycological resolution
For aspergillosis, IDSA recommends 3–5 mg/kg/day; higher end for CNS disease
Mucormycosis — first-line (off-label)5 mg/kg IV once daily5–10 mg/kg IV once daily10 mg/kg/dayHigher doses (10 mg/kg) for CNS involvement; combine with surgical debridement
ECMM/MSG 2019: minimum 5 mg/kg/day strongly recommended; step down to posaconazole or isavuconazole
Visceral leishmaniasis — immunocompetent3 mg/kg IV on days 1–53 mg/kg IV on days 14 and 21Total: 21 mg/kgRepeat course if parasitic clearance not achieved
High cure rate (96.5% at 6-month follow-up in immunocompetent patients) (FDA PI)
Visceral leishmaniasis — immunocompromised4 mg/kg IV on days 1–54 mg/kg IV on days 10, 17, 24, 31, 38Total: 40 mg/kgRelapse rate is very high (>88%) in immunocompromised patients; consult ID specialist
Maintenance or suppressive therapy may be required; no standard regimen established (FDA PI)
Histoplasmosis — moderate-to-severe disseminated (off-label)3 mg/kg IV once daily3 mg/kg IV once daily5 mg/kg/dayInduction for 1–2 weeks, then step down to oral itraconazole
IDSA guideline recommendation for moderate-to-severe or CNS histoplasmosis
Clinical Pearl: Formulation Safety

Amphotericin B liposomal (AmBisome) is not interchangeable on a mg-per-mg basis with amphotericin B deoxycholate, amphotericin B lipid complex (Abelcet), or amphotericin B cholesteryl sulfate (Amphotec). These formulations differ in pharmacokinetics, dosing, and toxicity profiles. Medication errors involving formulation confusion have caused serious nephrotoxicity and death. Always verify the specific amphotericin B product before administration.

Administration Notes

Reconstitute each 50 mg vial with 12 mL Sterile Water for Injection (yields 4 mg/mL). Shake vigorously for 30 seconds. Filter through the provided 5-micron filter into D5W to a final concentration of 1–2 mg/mL (0.2–0.5 mg/mL for infants/small children). Infuse over approximately 2 hours. Do NOT use saline for reconstitution or dilution, as precipitation will occur. Flush existing IV lines with D5W before infusion (FDA PI).

PK

Pharmacology of Amphotericin B Liposomal

Mechanism of Action

Amphotericin B liposomal exerts its antifungal activity through binding to ergosterol, the principal sterol in fungal cell membranes. This binding creates transmembrane pores that allow leakage of essential monovalent ions (potassium, sodium, hydrogen, chloride), disrupting electrochemical gradients and ultimately causing fungal cell death. The liposomal delivery system encapsulates amphotericin B within unilamellar bilayer liposomes less than 100 nm in diameter, which preferentially target fungal cells and reticuloendothelial tissues. This targeted delivery achieves high tissue concentrations in the liver, spleen, and lungs while reducing the direct binding to mammalian cholesterol-containing membranes that drives nephrotoxicity. The liposomal carrier also reduces uptake by renal tubular cells, which accounts for the improved renal safety profile compared with conventional amphotericin B deoxycholate. Amphotericin B retains broad-spectrum activity against Aspergillus, Candida, Cryptococcus, Blastomyces, Histoplasma, and Mucorales species.

ADME Profile

ParameterValueClinical Implication
AbsorptionIV administration only; 100% bioavailabilityNo oral formulation exists; amphotericin B is not absorbed from the GI tract
DistributionVss 0.10–0.44 L/kg (dose-dependent); concentrates in liver, spleen, lungs; nonlinear PK with greater than proportional increase in Cmax and AUC from 1–5 mg/kg/day; steady state by day 4Low volume of distribution reflects liposomal sequestration in the reticuloendothelial system; high tissue penetration despite low serum Vd; serum levels do not reflect tissue activity
MetabolismMetabolic pathways not characterized; not a CYP substrate, inducer, or inhibitorMinimal hepatic drug-drug interaction risk via CYP pathways; no dose adjustment for hepatic impairment formally studied
EliminationInitial t½ 7–10 h; terminal t½ 100–153 h (tissue redistribution); clearance at steady state 11–22 mL/hr/kg (dose-independent); excretion pathway not fully characterizedLong terminal half-life due to slow redistribution from tissues, not renal elimination; neither hemodialysis nor peritoneal dialysis removes amphotericin B liposomal effectively
SE

Side Effects of Amphotericin B Liposomal

Adverse event data are derived primarily from Study 94-0-002, a randomized double-blind trial of 687 febrile neutropenic patients comparing amphotericin B liposomal 3 mg/kg/day (n=343) with conventional amphotericin B 0.6 mg/kg/day (n=344), and from Study 94-0-013 in HIV-associated cryptococcal meningitis (n=267). Amphotericin B liposomal demonstrated a significantly lower incidence of nephrotoxicity and infusion-related reactions compared with conventional amphotericin B (FDA PI).

≥10% Very Common
Adverse EffectIncidenceClinical Note
Chills / rigors47.5%Most common infusion-related reaction; significantly less than conventional amphotericin B (75.9%); premedication with acetaminophen and diphenhydramine reduces severity
Hypokalemia42.9%Dose-related renal potassium wasting; monitor electrolytes daily; supplement aggressively to maintain K+ >3.5 mmol/L
Nausea39.7%Usually mild to moderate; antiemetic premedication may help
Diarrhea30.3%Generally self-limiting; assess for C. difficile if prolonged
Vomiting31.8%Often infusion-related; consider slowing infusion rate
Rash24.8%Non-specific; differentiate from anaphylaxis
Hyperglycemia23.0%Monitor blood glucose; may reflect steroid co-administration
Dyspnea23.0%Distinguish from infusion-related respiratory distress vs. underlying disease
Creatinine increased22.4%Lower than conventional amphotericin B (42.2%); nephrotoxicity defined as doubling of baseline creatinine: 18.7% vs. 33.7%
Alkaline phosphatase increased22.2%Monitor hepatic function panel; generally transient
BUN increased21.0%Part of nephrotoxicity profile; usually reversible on discontinuation
Hypomagnesemia20.4%Co-occurs with hypokalemia; supplement both electrolytes simultaneously
Abdominal pain19.8%Evaluate for GI pathology if severe
Headache19.8%Common; rule out meningeal disease in relevant populations
Blood product transfusion reaction18.4%Reflects underlying hematological condition rather than direct drug effect
Bilirubinemia18.1%Monitor LFTs; usually cholestatic pattern
Insomnia17.2%Steroid premedication may contribute
Hypotension14.3%Lower than conventional amphotericin B (21.5%); monitor vitals during infusion
Sepsis14.0%Reflects underlying immunocompromised state
ALT increased14.6%Monitor hepatic panel; hepatotoxicity generally reversible
Epistaxis14.9%Associated with thrombocytopenia from underlying disease
Tachycardia13.4%Lower than conventional amphotericin B (20.9%); infusion-related
Asthenia13.1%Multifactorial in critically ill patients
1–10% Common
Adverse EffectIncidenceClinical Note
Edema / peripheral edema14.3% / 14.6%Monitor fluid balance; adjust IV fluid administration
Anxiety13.7%Often situational in hospitalized immunocompromised patients
AST increased12.8%Usually mild; hepatocellular injury rare
Chest pain12.0%Differentiate infusion-related chest tightness from cardiac events
Confusion11.4%Consider metabolic causes including electrolyte disturbance
Infection11.1%Superinfection or new infection in immunocompromised host
Pruritus10.8%Usually mild; may be infusion-related
GI hemorrhage9.9%Monitor in thrombocytopenic patients
Hypertension7.9%Lower than conventional amphotericin B (16.3%); infusion-related
Back pain / flushing reaction2–10%Acute back pain with chest tightness can occur minutes after infusion start; resolves rapidly when infusion stopped; may not recur at slower rate
Serious Serious Adverse Effects (Regardless of Frequency)
Adverse EffectEstimated FrequencyTypical OnsetRequired Action
Nephrotoxicity (doubling of serum creatinine)18.7%Within first 1–2 weeks; cumulativeMonitor creatinine daily; aggressive saline loading (500–1000 mL NS before infusion) reduces risk; consider dose reduction if creatinine doubles; do not switch to conventional amphotericin B
Severe hypokalemia (≤2.5 mmol/L)6.7%Days to weeks of therapyMonitor potassium at least daily; supplement IV potassium aggressively; concurrent magnesium repletion essential for refractory hypokalemia; cardiac monitoring if K+ <3.0
Anaphylaxis / severe hypersensitivityRare (post-marketing)During or shortly after infusionStop infusion immediately; treat with epinephrine and supportive care; permanently discontinue amphotericin B liposomal; test dose not reliably predictive
Acute pulmonary toxicity (with leukocyte transfusions)RareDuring concurrent leukocyte infusionSeparate leukocyte transfusions from amphotericin B infusion by as long as possible; monitor respiratory status closely
Cardiac arrest / arrhythmia2–10% (arrhythmia); rare (arrest)Variable; often linked to electrolyte disturbanceMaintain potassium >3.5 and magnesium >1.5 mg/dL; cardiac monitoring in patients on digoxin or with pre-existing cardiac disease
Acute kidney failure2–10%Days to weeks; cumulative dose-relatedVolume expansion; avoid concurrent nephrotoxins; may require dose reduction or temporary discontinuation; renal function often recovers after stopping therapy
Hepatocellular damage / veno-occlusive liver disease2–10%VariableMonitor LFTs; discontinue if severe hepatotoxicity develops
RhabdomyolysisVery rare (post-marketing)VariableMonitor CK if myalgia develops; aggressive hydration; discontinue if confirmed
AgranulocytosisVery rare (post-marketing)VariableMonitor CBC; difficult to distinguish from underlying disease in neutropenic patients
Discontinuation Discontinuation Rates
AmBisome 3 mg/kg/day (Study 94-0-002)
14.3% vs 18.6% conventional amphotericin B
Top reasons: Toxicity or lack of efficacy; infusion-related reactions less likely to cause discontinuation than with conventional amphotericin B
AmBisome vs Abelcet (Study 97-0-034)
Lower with AmBisome vs amphotericin B lipid complex
Top reasons: Nephrotoxicity (doubling creatinine 14.5% AmBisome combined vs 42.3% ABLC); infusion-related chills
Reason for DiscontinuationAmBisomeContext
Nephrotoxicity18.7% (2x creatinine)vs 33.7% conventional amphotericin B in Study 94-0-002
Infusion-related reactionsLower than comparatorsNearly 3x fewer patients required dose reduction for toxicity vs conventional amphotericin B
Overall toxicity-related discontinuation14.3%Study 94-0-002; includes all causes
Managing Infusion-Related Reactions

Premedicate with acetaminophen 650 mg, diphenhydramine 25–50 mg, and optionally hydrocortisone 25–50 mg IV 30 minutes before infusion. If chills/rigors occur, meperidine 25–50 mg IV is effective for acute rigors. Slow the infusion rate if reactions occur; the infusion may be extended beyond 2 hours. Most infusion-related reactions diminish with subsequent doses. On Day 1 without premedication, fever occurred in 17% of AmBisome patients vs 44% with conventional amphotericin B (FDA PI).

Int

Drug Interactions with Amphotericin B Liposomal

No formal clinical drug interaction studies have been conducted with amphotericin B liposomal. Because amphotericin B is not metabolized through cytochrome P450 enzymes, pharmacokinetic interactions are uncommon. However, pharmacodynamic interactions are clinically important, particularly those that compound nephrotoxicity or electrolyte disturbances. The interactions below are based on the known interaction profile of amphotericin B and the specific warnings in the AmBisome prescribing information.

Major Nephrotoxic Agents (aminoglycosides, vancomycin, cidofovir, foscarnet, cyclosporine, tacrolimus)
MechanismAdditive renal tubular toxicity
EffectIncreased risk of acute kidney injury, even with the liposomal formulation
ManagementMonitor creatinine and urine output daily; pre-hydrate with 500–1000 mL NS; avoid concomitant use when possible; if unavoidable, dose-adjust the nephrotoxin and extend monitoring
FDA PI
Major Digitalis Glycosides (digoxin)
MechanismAmphotericin B-induced hypokalemia potentiates digitalis cardiotoxicity
EffectIncreased risk of fatal cardiac arrhythmias, including ventricular tachycardia
ManagementMonitor serum potassium at least daily; maintain K+ >4.0 mmol/L if possible; monitor digoxin levels and ECG
FDA PI
Major Antineoplastic Agents
MechanismOverlapping organ toxicity (nephrotoxicity, bronchospasm, hypotension)
EffectEnhanced renal impairment, pulmonary complications, and hemodynamic instability
ManagementAdminister with caution; stagger administration times when possible; monitor renal function and respiratory status closely
FDA PI
Major Leukocyte Transfusions
MechanismPulmonary endothelial damage from activated leukocytes combined with amphotericin B membrane effects
EffectAcute pulmonary toxicity with dyspnea, hypoxia, and pulmonary infiltrates
ManagementSeparate leukocyte transfusions from amphotericin B infusion by the maximum feasible interval; monitor SpO2 continuously during both infusions
FDA PI
Moderate Corticosteroids / ACTH
MechanismCorticosteroids promote renal potassium excretion, compounding amphotericin B-induced hypokalemia
EffectSevere hypokalemia with risk of cardiac dysfunction
ManagementMonitor serum electrolytes and cardiac function closely; aggressive potassium and magnesium supplementation
FDA PI
Moderate Flucytosine (5-FC)
MechanismAmphotericin B-induced renal impairment reduces flucytosine clearance; enhanced cellular uptake through amphotericin pores
EffectIncreased flucytosine toxicity (myelosuppression, hepatotoxicity)
ManagementMonitor flucytosine levels (target peak 30–80 mcg/mL); monitor CBC and LFTs; dose-adjust flucytosine for renal function changes
FDA PI
Moderate Skeletal Muscle Relaxants (e.g., tubocurarine, vecuronium)
MechanismAmphotericin B-induced hypokalemia enhances neuromuscular blockade
EffectProlonged paralysis and respiratory depression
ManagementCorrect potassium before surgery; monitor neuromuscular function closely; anesthesia team should be informed
FDA PI
Minor Azole Antifungals (ketoconazole, fluconazole, itraconazole)
MechanismIn vitro and animal data suggest azoles may induce fungal resistance to amphotericin B by reducing ergosterol content
EffectTheoretical antagonism; clinical significance uncertain
ManagementSequential use (amphotericin B induction followed by azole consolidation) is standard practice and clinically appropriate; concurrent use requires clinical judgment, especially in immunocompromised patients
FDA PI
Laboratory Interaction: False Phosphate Elevation

The PHOSm assay (used in some Beckman Coulter analyzers) may report falsely elevated serum phosphate levels in patients receiving amphotericin B liposomal. If hyperphosphatemia appears inconsistent with the clinical picture, confirm with an alternative assay method before initiating treatment for hyperphosphatemia (FDA PI).

Mon

Monitoring for Amphotericin B Liposomal

  • Serum Creatinine & BUN Baseline, then daily
    Routine
    Nephrotoxicity occurs in ~19% of patients (doubling creatinine). Trend creatinine daily; if doubling occurs, consider dose reduction or temporary hold. Pre-hydration with 500–1000 mL normal saline is protective.
  • Serum Potassium Baseline, then daily
    Routine
    Hypokalemia (≤2.5 mmol/L) occurs in ~7% of patients. Renal potassium wasting is the primary mechanism. Supplement aggressively; refractory hypokalemia often reflects concurrent hypomagnesemia.
  • Serum Magnesium Baseline, then daily
    Routine
    Hypomagnesemia occurs in ~20% of patients. Must be repleted alongside potassium; magnesium depletion impairs potassium conservation.
  • Hepatic Function Panel Baseline, then 2–3x/week
    Routine
    Elevated alkaline phosphatase (~22%), bilirubin (~18%), and transaminases (~13–15%) are common. Hepatotoxicity is generally reversible but monitor for veno-occlusive disease in transplant recipients.
  • Complete Blood Count Baseline, then 2x/week
    Routine
    Anemia occurs in 27–48% (dose-dependent); thrombocytopenia in 6–13%. Monitor for hematologic recovery in neutropenic patients.
  • Vital Signs During Infusion Every infusion, especially first doses
    Routine
    Monitor temperature, blood pressure, heart rate, respiratory rate, and SpO2 during infusion. Infusion-related fever (17%), chills (18%), hypotension (3.5%), and tachycardia (2.3%) were reported on Day 1.
  • Serum Phosphate If hyperphosphatemia reported
    Trigger-based
    False elevation possible with PHOSm assay on Beckman Coulter analyzers. Confirm with alternative assay if result is clinically unexpected.
  • Blood Glucose Daily during therapy
    Routine
    Hyperglycemia (~23%); may be compounded by concurrent corticosteroid use. Adjust insulin as needed.
CI

Contraindications & Cautions for Amphotericin B Liposomal

Absolute Contraindications

  • Known hypersensitivity to amphotericin B deoxycholate or any component of the liposomal formulation (phospholipids, cholesterol, alpha-tocopherol, sucrose) — unless the treating physician determines that the benefit of therapy outweighs the risk of a hypersensitivity reaction (FDA PI)

Relative Contraindications (Specialist Input Recommended)

  • Pre-existing severe renal impairment (CrCl <10 mL/min): While amphotericin B liposomal is significantly less nephrotoxic than conventional amphotericin B and has been used successfully in patients with pre-existing renal impairment, risk-benefit assessment and nephrologist consultation are warranted. Dialysis does not effectively remove the drug.
  • Concurrent use with other nephrotoxic agents: If avoidable, defer concurrent nephrotoxic drug therapy; if unavoidable, intensive renal monitoring and pre-hydration are essential.
  • Patients with non-invasive fungal infections: Amphotericin B liposomal should not be used for non-invasive fungal infections (e.g., oral thrush, vaginal candidiasis, esophageal candidiasis) in patients with normal neutrophil counts. The toxicity profile does not justify use for these indications.

Use with Caution

  • Pregnancy: No adequate controlled studies in pregnant women. Animal studies showed no teratogenicity in rats (up to 5 mg/kg) or rabbits (up to 3 mg/kg), but higher doses in rabbits were associated with increased spontaneous abortions. Use only if the potential benefit justifies the potential risk to the fetus.
  • Lactation: It is unknown whether amphotericin B liposomal is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision must be made whether to discontinue nursing or the drug.
  • Pediatric patients <1 month of age: Safety and effectiveness not established in neonates under 1 month.
  • Elderly patients (≥65 years): Limited experience (72 patients in clinical program); no dose adjustment required, but monitor renal function closely.
  • Hepatic impairment: The effect of hepatic impairment on the disposition of amphotericin B liposomal is unknown. Monitor hepatic function.
  • Patients on concurrent digitalis glycosides: Hypokalemia potentiates digitalis toxicity; maintain potassium levels meticulously.
FDA Class-Wide Regulatory Warning Formulation Non-Interchangeability

Amphotericin B liposomal (AmBisome) is NOT interchangeable with other amphotericin B-containing products on a mg-per-mg basis. Conventional amphotericin B deoxycholate, amphotericin B lipid complex (Abelcet), and amphotericin B cholesteryl sulfate (Amphotec) differ substantially in pharmacokinetics, dosing, and toxicity. Overdosage due to formulation confusion may result in severe nephrotoxicity and death. Always verify the specific amphotericin B formulation before prescribing and dispensing.

FDA Warning Anaphylaxis Risk

Anaphylaxis has been reported with amphotericin B-containing drugs, including AmBisome. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of amphotericin B liposomal. During the initial dosing period, patients should be under close clinical observation by medically trained personnel.

Pt

Patient Counselling for Amphotericin B Liposomal

Purpose of Therapy

Amphotericin B liposomal is a powerful antifungal medication used to treat serious, potentially life-threatening fungal infections. It is given by intravenous infusion in a hospital or supervised clinical setting. The liposomal formulation is designed to be gentler on the kidneys than older versions of the same medication, but close monitoring is still essential throughout the course of treatment.

How Treatment Is Given

The medication is infused through a vein over approximately 2 hours, typically once daily. Treatment duration varies by the type and severity of infection and may last from several days to several weeks. Blood tests will be performed frequently during treatment to check kidney function, electrolyte levels, and blood counts.

Infusion-Related Reactions (Chills, Fever, Rigors)
Tell patient Shaking chills, fever, nausea, or headache during or shortly after the infusion are common, especially during the first few doses. Pre-medications (acetaminophen, antihistamines) are given to reduce these symptoms. These reactions usually become less severe over subsequent infusions.
Call prescriber If experiencing severe shortness of breath, chest tightness, swelling of the face or throat, or persistent high fever that does not respond to treatment — these could indicate a serious allergic reaction requiring immediate medical attention.
Kidney Effects
Tell patient This medication can affect kidney function even in its gentler liposomal form. Blood tests will be done daily to monitor kidney health. Staying well-hydrated helps protect the kidneys, and IV fluids will be given before each dose.
Call prescriber If noticing a significant decrease in urine output, unusual swelling in the legs or ankles, or persistent nausea and fatigue that may indicate worsening kidney function.
Electrolyte Changes (Low Potassium and Magnesium)
Tell patient The medication can cause the body to lose potassium and magnesium through the kidneys. Supplements may be given to replace these minerals. Symptoms of low potassium include muscle weakness, cramps, and irregular heartbeat.
Call prescriber If experiencing palpitations, severe muscle weakness, muscle cramps that do not resolve, or fainting spells.
Nausea, Vomiting, and Diarrhea
Tell patient Gastrointestinal symptoms are common (affecting approximately one-third of patients) but are usually manageable with anti-nausea medications. Report persistent symptoms to ensure adequate nutrition and hydration are maintained.
Call prescriber If unable to keep down fluids, if diarrhea becomes severe or bloody, or if abdominal pain is worsening.
Back Pain or Chest Tightness During Infusion
Tell patient A small number of patients experience sudden back pain, flushing, or chest tightness within minutes of starting the infusion. This typically resolves quickly when the infusion is slowed or briefly stopped. It does not necessarily recur with subsequent doses.
Call prescriber Inform the nursing team immediately if these symptoms occur during infusion so the rate can be adjusted.
Ref

Sources

Regulatory (PI / SmPC)
  1. AmBisome (amphotericin B) liposome for injection. Full Prescribing Information. Astellas Pharma US, Inc. / Gilead Sciences, Inc. Revised 2024. FDA Label (PDF) Primary source for all FDA-approved dosing, indications, adverse events, and pharmacokinetic data presented in this monograph.
  2. DailyMed. Amphotericin B liposome — amphotericin B injection, powder, lyophilized, for solution. U.S. National Library of Medicine. DailyMed Continuously updated FDA label database for the most current prescribing information.
Key Clinical Trials
  1. Walsh TJ, Finberg RW, Arndt C, et al. Liposomal amphotericin B for empirical therapy in patients with persistent fever and neutropenia. N Engl J Med. 1999;340(10):764–771. doi:10.1056/NEJM199903113401004 Landmark RCT (Study 94-0-002) establishing equivalence of AmBisome to conventional amphotericin B in febrile neutropenia with superior safety.
  2. Leenders AC, Reiss P, Portegies P, et al. Liposomal amphotericin B (AmBisome) compared with amphotericin B both followed by oral fluconazole in the treatment of AIDS-associated cryptococcal meningitis. AIDS. 1997;11(12):1463–1471. doi:10.1097/00002030-199712000-00010 Pivotal trial comparing AmBisome dosing regimens (3 and 6 mg/kg) to conventional amphotericin B for HIV-associated cryptococcal meningitis.
  3. Herbrecht R, Denning DW, Patterson TF, et al. Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis. N Engl J Med. 2002;347(6):408–415. doi:10.1056/NEJMoa020191 Established voriconazole as preferred first-line for invasive aspergillosis; positions liposomal amphotericin B as alternative.
  4. Cornely OA, Maertens J, Bresnik M, et al. Liposomal amphotericin B as initial therapy for invasive mold infection: a randomized trial comparing a high-loading dose regimen with standard dosing (AmBiLoad trial). Clin Infect Dis. 2007;44(10):1289–1297. doi:10.1086/514341 Showed no benefit of 10 mg/kg loading dose over standard 3 mg/kg for invasive mold infections, with increased nephrotoxicity at higher doses.
Guidelines
  1. Patterson TF, Thompson GR 3rd, Denning DW, et al. Practice guidelines for the diagnosis and management of aspergillosis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2016;63(4):e1–e60. doi:10.1093/cid/ciw326 IDSA guideline positioning liposomal amphotericin B as alternative first-line therapy for invasive aspergillosis when voriconazole is contraindicated.
  2. Cornely OA, Alastruey-Izquierdo A, Arenz D, et al. Global guideline for the diagnosis and management of mucormycosis: an initiative of the ECMM in cooperation with the MSG ERC. Lancet Infect Dis. 2019;19(12):e405–e421. doi:10.1016/S1473-3099(19)30312-3 Global consensus guideline strongly recommending high-dose liposomal amphotericin B (minimum 5 mg/kg/day) as first-line treatment for mucormycosis.
  3. Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guideline for the management of candidiasis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2016;62(4):e1–e50. doi:10.1093/cid/civ933 IDSA candidiasis guideline recommending amphotericin B as the preferred antifungal in pregnancy and as salvage therapy for invasive candidiasis.
  4. Skiada A, Lanternier F, Groll AH, et al. Diagnosis and treatment of mucormycosis in patients with hematological malignancies: guidelines from the 3rd European Conference on Infections in Leukemia (ECIL 3). Haematologica. 2013;98(4):492–504. doi:10.3324/haematol.2012.065110 ECIL guidelines recommending liposomal amphotericin B at 5 mg/kg/day minimum with surgical debridement for mucormycosis.
Mechanistic / Basic Science
  1. Laniado-Laborin R, Cabrales-Vargas MN. Amphotericin B: side effects and toxicity. Rev Iberoam Micol. 2009;26(4):223–227. doi:10.1016/j.riam.2009.06.003 Review of the mechanistic basis for amphotericin B toxicity, including ergosterol-binding selectivity and renal tubular injury pathways.
  2. Adler-Moore J, Proffitt RT. AmBisome: liposomal formulation, structure, mechanism of action and pre-clinical experience. J Antimicrob Chemother. 2002;49(Suppl 1):21–30. doi:10.1093/jac/49.suppl_1.21 Detailed review of the liposomal delivery system, explaining the mechanism by which the unilamellar lipid bilayer reduces toxicity while preserving antifungal activity.
Pharmacokinetics / Special Populations
  1. Heinemann V, Bosse D, Jehn U, et al. Pharmacokinetics of liposomal amphotericin B (AmBisome) in critically ill patients. Antimicrob Agents Chemother. 1997;41(6):1275–1280. doi:10.1128/AAC.41.6.1275 Characterization of nonlinear pharmacokinetics and dose-dependent volume of distribution in critically ill patients.
  2. Groll AH, Piscitelli SC, Walsh TJ. Clinical pharmacology of systemic antifungal agents: a comprehensive review of agents in clinical use, current investigational compounds, and putative targets for antifungal drug development. Adv Pharmacol. 1998;44:343–500. doi:10.1016/S1054-3589(08)60129-5 Comprehensive pharmacological review covering amphotericin B formulations, with detailed tissue distribution and elimination data relevant to dose selection.
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