Safety and tolerability profile

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I am... well established with respect to safety profile and tolerability1‑5

The liposomal formulation of AmBisome® reduces nephrotoxicity vs. other amphotericin B formulations.1,6

Liposomal delivery restricts cell death to targeted fungal cells, which reduces the potential for freely circulating amphotericin B and off‑target toxicity vs. other formulations of amphotericin B.6,7

Liposomes

Individual AmBisome® liposomes have been shown to penetrate the porous fungal cell well intact.6

Amphotericin B and liposomes

Amphotericin B remains bound within the liposome during entry, then dissociates from the liposomes and binds irreversibly with ergosterol in the fungal cell membrane.6,8,9

The liposomal delivery of AmBisome® reduces nephrotoxicity, infusion-related reactions, and hypokalaemia, which may positively impact length of hospital stay10,11

vs.

Other forms of amphotericin B1,7,8,10‑16

Scroll down to discover how the liposomal delivery of AmBisome® is associated with lower toxicity compared with other amphotericin B formulations

Frequency of severe nephrotoxicity*10

2.4%

AmBisome®

vs. (p=0.046)

7.2%

Conventional amphotericin B

11.5%

Amphotericin B lipid complex

Adapted from Falci et al. 2015

*Data from a retrospective cohort study of 431 patients who received either amphotericin B deoxycholate (conventional amphotericin B; n=236), liposomal amphotericin B (AmBisome®; n=105), or amphotericin B lipid complex (n=90).10

Infusion-related reactions**11

KEY
  • AmBisome®
  • Conventional amphotericin B

Infusion-related increases in temperatures of more than 1°C

AmBisome® 7.4%
7.4% (n=267)
vs.
Conventional amphotericin B 16.0%
16.0% (n=544) p<0.001

Infusion-related reactions without fever

AmBisome® 20.6%
20.6% (n=746)
vs.
Conventional amphotericin B 52.2%
52.2% (n=1776) p<0.001

Adapted from Walsh 1999.

**Data from 687 febrile, neutropenic patients who either received liposomal amphotericin B (AmBisome® 3mg/kg/day; n=343) or conventional amphotericin B (0.6 mg/kg/day; n=344), a total of 3,622 infusions. The study included a broad range of patients in terms of age (liposomal amphotericin B: 2-79 years; conventional amphotericin B: 2-80 years), gender, race, risk category, and primary diagnosis.11

Hypokalaemia†11

KEY
  • AmBisome®
  • Conventional amphotericin B
AmBisome® 6.7%
(n=23)
vs.
Conventional amphotericin B 11.6%
(n=40); p=0.02

Adapted from Walsh et al. 1999.

†Data from 687 febrile, neutropenic patients who either received liposomal amphotericin B (AmBisome® 3 mg/kg/day; n=343) or conventional amphotericin B (0.6 mg/kg/day; n=344). The study included a broad range of patients in terms of age (liposomal amphotericin B: 2-79 years; conventional amphotericin B: 2-80 years), gender, race, risk category, and primary diagnosis.11

Median hospital stay‡10

26 days
AmBisome®
vs. (p=0.071, not significant)
34 days
Conventional amphotericin B
35 days
Amphotericin B lipid complex

Adapted from Falci et al. 2015.

‡Data from a retrospective cohort study of 431 patients who received either amphotericin B deoxycholate (conventional amphotericin B; n=236), liposomal amphotericin B (AmBisome®; n=105) or amphotericin B lipid complex (n=90).10

Adverse events associated with AmBisome®1

AmBisome® has a well-established safety and tolerability profile with over 30 years of clinical experience1,5

Explore below to learn more about some of the reported adverse events (very common and common) associated with AmBisome®

  • Head

    • Very common: Rigors, pyrexia
    • Common: Headache

  • Heart/chest

    • Common: Tachycardia, chest pain, hypotension, vasodilation, flushing, dyspnoea

  • Stomach/belly

    • Very common: Nausea, vomiting
    • Common: Diarrhoea, abdominal pain

  • Kidneys

    • Very common: Hypokalaemia
    • Common: Increased creatinine, increased blood urea, hyponatremia, hypocalcaemia, hypomagnesaemia, hyperglycaemia

  • Liver

    • Common: Abnormal liver function tests, hyperbilirubinaemia, increased alkaline phosphatase

  • Arm/skin

    • Common: Rash

  • Back

    • Common: Back pain

Adverse reactions have been attributed to AmBisome® based on clinical trial data and post-marketing experience. The frequency is based on analysis from pooled clinical trials of 688 AmBisome®-treated patients; the frequency of adverse reactions identified from post-marketing experience is not known. Adverse reactions are sorted by frequency, and within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10).

30 years

Over 30 years of clinical
experience5

Over 2 million patients treated

Over 2 million patients have been treated with AmBisome®3

63 countries

Approved for use in 63 countries around the world, across nearly every continent4

With over 30 years' experience, take on invasive fungal infections (IFIs) with confidence with AmBisome®'s well-established safety and tolerability profile1,5

Dive into more data with our interactive gallery

View the gallery

References:

  1. AmBisome® Summary of Product Characteristics (UK). Available at: https://www.medicines.org.uk/emc/product/1022/smpc#gref. [Last accessed: April 2022].
  2. Gilead. Data on File. AMBUK1402.
  3. Gilead. Data on File: AmBisome® Periodic Safety Update Report/Periodic Benefit-Risk Report (Period covered: March 2020–March 2021). Published May 2021.
  4. Gilead. Data on File. Worldwide marketing authorization status: AmBisome®. October 2020.
  5. AmBisome® Summary of Product Characteristics (Ireland). Available at: https://www.medicines.ie/medicines/ambisome-liposomal-amphotericin--31254/spc#tabs. [Last accessed: April 2022].
  6. Walker L et al. MBio. 2018;9(1):e02383-17.
  7. Adler-Moore JP et al. Med Mycol. 2016;54(3):223–231.
  8. Stone NR et al. Drugs. 2016;76(4):485–500.
  9. Mesa-Arango AC et al. Front Microbiol. 2012;3:286.
  10. Falci DR et al. Mycoses. 2015;58:104–112.
  11. Walsh TJ et al. N Engl J Med. 1999;340(10):764–771.
  12. Adler-Moore JP and Proffitt RT. J Antimicrob Chemother. 2002;49(Suppl.1):21–30.
  13. Keady S and Panesar P. EJHP Practice. 2010;16(3):78–80.
  14. Ullmann A et al. Clin Infect Dis. 2006;43:e29–e38.
  15. Wingard JT et al. Clin Infect Dis. 2000;31:1155–1163.
  16. Leenders AC et al. Br J Haematol. 1998;103:205–212.

Job code: IHQ-AMB-0527
Date of Preparation: April 2022