Amphotericin B chemical structure
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Amphotericin B (Fungilin®, Fungizone®, Abelcet®, AmBisome®, Fungisome®, Amphocil®, Amphotec®) is a polyene antimycotic drug, used intravenously in systemic fungal infections. It was originally extracted from Streptomyces nodosus fungi. Currently the drug is available as plain Amphotericin B, as cholesteryl sulfate complex, as lipid complex, and as liposomal formulation. The latter formulations have been developed to improve tolerability for the patient but may show considerable pharmacokinetic characteristics compared to plain Amphotericin B. more...

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Uses

Oral preparations of amphotericin B are used to treat oral thrush; these are virtually nontoxic. The main i.v. use is in systemic fungal infections (e.g. in immunocompromised patients), and in visceral leishmaniasis. Aspergillosis, cryptococcus infections (e.g. meningitis) and candidiasis are treated with amphotericin B. It is also used empirically in febrile immunocompromised patients who do not respond to broad-spectrum antibiotics.

Method of action

As with other polyene antifungals, amphotericin B associates with ergosterol, a membrane chemical of fungi, forming a pore that leads to K+ leakage and fungal cell death. Recently, however, researchers found evidence that pore formation is not necessarily linked to cell death (i.e. Angewandte Chemie Int. Ed. Engl. 2004). The actual mechanism of action may be more complex and multi-faceted.

Side effects

Very often a most serious acute reaction after the infusion (1 to 3 hours later) is noted consisting of fever, shaking chills, hypotension, anorexia, nausea, vomiting, headache, dyspnea, and tachypnea. This reaction sometimes subsides with later applications of the drug and may in part be due to histamine liberation. An increase in prostaglandin-synthesis may also play a role. Often the most difficult decision has to be made, whether the fever is disease- or drug-related. In order to decrease the likelihood and severity of the symptoms, initial doses should be low and increased slowly. The liposomal preperation obviously has a lower incidence of the syndrome. Acetaminophen, pethidine, diphenhydramine and/or hydrocortisone have all be used to treat or prevent the syndrome, but the prophylactic use of these drugs should be limited.

Nephrotoxicity (kidney damage) is a major issue and can be severe and/or irreversible. It is much milder when amphotericin B is delivered in liposomes (AmBisome). Electrolyte imbalances (e.g. hypokalema and hypocalcemia) may also occur.

Increased liver enzymes and hepatotoxicity up to acute liver failure, several forms of anemia and other blood dyscrasias (leukopenia, thrombopenia), serious cardiac arrhythmias (including ventricular fibrillation), and cardiac failure have also been reported frequently. Skin reactions, including serious forms, are also possible.

Interactions

  • Flucytosine : Toxicity of Flucytosine increased and vice versa
  • Diuretics or Cisplatin : Increased renal toxicity and incrised risk of hypokalema
  • Corticosterioids : Increased risk of hypokalema
  • Cytostatic drugs : Increased risk of kidney damage, hypotension and bronchospasms.
  • Other nephrotoxic drugs : Increased risk of serious renal damage. Monitor patients closely.
  • Foscarnet, Ganciclovir, Tenofovir, Adefovir : Risk of hematological and renal side-effects of Amphotericin B increased.
  • Transfusion of Leukocytes : Risk of pulmonal (lung) damage. Space intervalls between the application of Amphotericin B and the transfusion and monitor pulmonal function.

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Gilead Sciences, Inc - Corporate Capabilities
From Pharmaceutical Technology, 12/1/03

Company description

Gilead Sciences is an independent biopharmaceutical company that discovers, develops, and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has demonstrated its capability to develop and commercialize products throughout the world over the last 15 years. Gilead has successfully marketed its anti-infective product line consisting of AmBisome[R] (amphotericin B) liposome for injection, Viread[R] (tenofovir disoproxil fumarate), Hepsera[TM] (adefovir dipivoxil), Vistide[R] (cidofovir injection), and DaunoXome[R] (liposomal daunorubicin). Liposomal products include AmBisome, which is approved in 46 countries for treating life-threatening fungal infections, and DaunoXome, which is approved in more than 20 countries for the treatment of AIDS-related Kaposi's Sarcoma.

Gilead continues to leverage its expertise and proprietary technology in the field of liposomal drug delivery through its own internal development of product candidates as well as through collaborations with third parties for formulation, development, and manufacturing services relevant to their needs. Gilead's facilities in San Dimas, California are dedicated to liposome research and development and to pilot through commercial scale production of both liquid and lyophilized presentations.

Technology description

At Gilead, we have the proven scientific and regulatory expertise in liposomal drug development to maximize the success of your therapeutic compounds. Gilead's Liposome Technology Group offers an in-depth understanding of the subtleties of liposome formulation and a proven track record in designing liposomes that are amenable to scale-up, regulatory approval, and commercialization. While Gilead has successfully commercialized anti-infective and anti-cancer liposomal products, it has expertise in formulating active agents from a wide range of other therapeutic categories. Whether drug solubilization or therapeutic index improvement is the goal in formulating a compound, Gilead's SOLVE[SM] and VECTOR[SM] systems provide formulation options. Gilead has partnered with companies requiring assistance at all stages of the product development cycle from initial formulation development through commercial-scale manufacturing. For more information on Gilead's Liposome Technology Group, please visit www.gilead.com or call our business development department at 909.394.4179.

Gilead Sciences, Inc.

650 Cliffside Dr.

San Dimas CA 91773

TELEPHONE

909.394.4179

FAX

909.592.8530

WEB SITE

www.gilead.com

E-MAIL

cskenes@gilead.com

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COPYRIGHT 2003 Advanstar Communications, Inc.
COPYRIGHT 2004 Gale Group

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