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Anaphylaxis has been reported with amphotericin B desoxycholate and other amphotericin B-containing drugs. Anaphylaxis has been reported with ABELCET® (amphotericin b) with an incidence rate of < 0.1%. If severe respiratory distress occurs, the infusion should be immediately discontinued. The patient should not receive further infusions of ABELCET® (amphotericin b) .
As with any amphotericin B-containing product, during the initial dosing of ABELCET® (amphotericin b) , the drug should be administered under close clinical observation by medically trained personnel.
Acute reactions including fever and chills may occur 1 to 2 hours after starting an intravenous infusion of ABELCET® (amphotericin b) . These reactions are usually more common with the first few doses of ABELCET® (amphotericin b) and generally diminish with subsequent doses. Infusion has been rarely associated with hypotension, bronchospasm, arrhythmias, and shock.
Serum creatinine should be monitored frequently during ABELCET® therapy (see ADVERSE REACTIONS). It is also advisable to regularly monitor liver function, serum electrolytes (particularly magnesium and potassium), and complete blood counts.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
No long-term studies in animals have been performed to evaluate the carcinogenic potential of ABELCET® (amphotericin b) . The following in vitro (with and without metabolic activation) and in vivo studies to assess ABELCET® (amphotericin b) for mutagenic potential were conducted: bacterial reverse mutation assay, mouse lymphoma forward mutation assay, chromosomal aberration assay in CHO cells, and in vivo mouse micronucleus assay. ABELCET® (amphotericin b) was found to be without mutagenic effects in all assay systems. Studies demonstrated that ABELCET® (amphotericin b) had no impact on fertility in male and female rats at doses up to 0.32 times the recommended human dose (based on body surface area considerations).
There are no reports of pregnant women having been treated with ABELCET® (amphotericin b) . Teratogenic Effects. Pregnancy Category B: Reproductive studies in rats and rabbits at doses of ABELCET® (amphotericin b) up to 0.64 times the human dose revealed no harm to the fetus. Because animal reproductive studies are not always predictive of human response, and adequate and well-controlled studies have not been conducted in pregnant women, ABELCET® (amphotericin b) should be used during pregnancy only after taking into account the importance of the drug to the mother.
It is not known whether ABELCET® (amphotericin b) is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in breast-fed infants from ABELCET® (amphotericin b) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
One hundred eleven children (2 were enrolled twice and counted as separate patients), age 16 years and under, of whom 11 were less than 1 year, have been treated with ABELCET® (amphotericin b) at 5 mg/kg/day in two open-label studies and one small, prospective, single-arm study. In one single-center study, 5 children with hepatosplenic candidiasis were effectively treated with 2.5 mg/kg/day of ABELCET® (amphotericin b) . No serious unexpected adverse events have been reported.
Forty-nine elderly patients, age 65 years or over, have been treated with ABELCET® (amphotericin b) at 5 mg/kg/day in two open-label studies and one small, prospective, single-arm study. No serious unexpected adverse events have been reported.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/2/2009
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