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Amphotec

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.

Read more at Wikipedia.org

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FDA Gives SEQUUS Go-Ahead To Include Expanded Safety Information In AMPHOTEC Label
From Business Wire, 9/18/97

MENLO PARK, Calif.--(BUSINESS WIRE)--Sept. 18, 1997--SEQUUS Pharmaceuticals, Inc. (Nasdaq:SEQU) today announced that the U.S. Food and Drug Administration has granted permission to include additional favorable safety and dosing information in the label of its antifungal drug AMPHOTEC(R) (amphotericin B cholesteryl sulfate complex for injection). The new labeling includes additional information on AMPHOTEC's strong renal safety profile, especially in patients receiving cyclosporine or tacrolimus therapy. In addition, the new labeling includes information on the safety of AMPHOTEC in pediatric patients.

"We are pleased that the FDA has agreed to include this additional information in the AMPHOTEC label," said Dr. I. Craig Henderson, Chairman and Chief Executive Officer of SEQUUS. "AMPHOTEC now has specific labeling to support its use in children and patients receiving potentially nephrotoxic concomitant therapy. Because of AMPHOTEC's strong safety profile and its efficacy at lower doses, we are confident that physicians will continue to choose AMPHOTEC."

AMPHOTEC was approved for market clearance by the FDA on November 22, 1996 and is indicated for the treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of conventional amphotericin B therapy in effective doses, and in patients where prior amphotericin B therapy has failed.

The new label states that AMPHOTEC's recommended dosage is 3-4 mg/kg/day as required. The original label recommended a dose of 3-4 mg/kg/day with the option to increase the dose, if needed, to up to 6 mg/kg/day.

The new label also includes additional safety and efficacy information from a comparative study designed primarily to compare the safety profiles of AMPHOTEC and amphotericin B as empiric therapy for febrile neutropenia.

In the randomized, double-blind, multicenter study, patients treated with AMPHOTEC experienced significantly less increases in serum creatinine levels than patients treated with amphotericin B. Adults and pediatric patients receiving cyclosporine or tacrolimus therapy with AMPHOTEC had a significantly lower rate of renal toxicity, compared to patients treated with amphotericin B. The study also showed that pediatric patients (< 16 years) treated with AMPHOTEC had significantly less renal toxicity than amphotericin B.

SEQUUS also announced that it has withdrawn its supplemental New Drug Application (sNDA) to expand AMPHOTEC s indication to include empiric treatment of neutropenic patients with fever of unknown origin (commonly referred to as FUO). "In standard practice, physicians often have a choice of antifungal drugs, including the new lipoid antifungals, to treat patients with FUO before receiving confirmation of fungal infections," said Dr. Henderson. "We believe AMPHOTEC is the gold standard of the lipid amphotericin B formulations and we are confident physicians will continue to choose AMPHOTEC for its strong renal safety and efficacy profile."

Established in 1981, with headquarters in Menlo Park, California (and with offices in London, England), SEQUUS is developing proprietary pharmaceutical products for the treatment of cancer, systemic fungal infections and other life threatening diseases. SEQUUS developed and is commercializing DOXIL(R), an anticancer product formulated in the Company's proprietary long-circulating STEALTH(R) liposomes, and AMPHOTECT(TM), an antifungal agent, in the United States, Europe, Latin America and other foreign markets. Pipeline products encompass additional anticancer drugs, including SPI-077, a STEALTH liposome formulation of cisplatin, Ciprofloxacin, CD4, radio-sensitizers, and development of the proprietary STEALTH technology platform to deliver a range of biotechnology and pharmaceutical products, including genes, proteins, peptides, antisense and small molecules.

CONTACT: SEQUUS Pharmaceuticals, Inc., Menlo Park

I. Craig Henderson, M.D.

415/323-9011

Ogilvy Adams & Rinehart, New York

(Media Inquiries)

Susan Eckstein, 212/880-5207

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