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The total safety data base is composed of 921 patients treated with ABELCET® (amphotericin b) (5 patients were enrolled twice and counted as separate patients), of whom 775 were treated with 5 mg/kg/day. Of these 775 patients, 194 patients were treated in four comparative studies; 25 were treated in open-label, non-comparative studies; and 556 patients were treated in an open-label, emergency-use program. Most had underlying hematologic neoplasms, and many were receiving multiple concomitant medications. Of the 556 patients treated with ABELCET® (amphotericin b) , 9% discontinued treatment due to adverse events regardless of presumed relationship to study drug.
Adverse Eventsa with an Incidence of ≥ 3% (N=556)
|Adverse Event||Percentage (%) of Patients|
|Increased Serum Creatinine||11|
|Multiple Organ Failure||11|
|Nausea and Vomiting||3|
|a The causal association between these adverse events and ABELCET® is uncertain.|
The following adverse events have also been reported in patients using ABELCET® (amphotericin b) in open-label, uncontrolled clinical studies. The causal association between these adverse events and ABELCET® (amphotericin b) is uncertain.
Cardiopulmonary:cardiac failure, pulmonary edema, shock, myocardial infarction, hemoptysis, tachypnea, thrombophlebitis, pulmonary embolus, cardiomyopathy, pleural effusion, arrhythmias including ventricular fibrillation.
Musculoskeletal: myasthenia, including bone, muscle, and joint pains
Neurologic: convulsions, tinnitus, visual impairment, hearing loss, peripheral neuropathy, transient vertigo, diplopia, encephalopathy, cerebral vascular accident, extrapyramidal syndrome and other neurologic symptoms
Liver function test abnormalities: increased AST, ALT, alkaline phosphatase, LDH
Renal function test abnormalities: increased BUN
Read the Abelcet (amphotericin b injection) Side Effects Center for a complete guide to possible side effects
No formal clinical studies of drug interactions have been conducted with ABELCET® (amphotericin b) . However, when administered concomitantly, the following drugs are known to interact with amphotericin B; therefore, the following drugs may interact with ABELCET® (amphotericin b) :
Antineoplastic agents: Concurrent use of antineoplastic agents and amphotericin B may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly with ABELCET® (amphotericin b) with great caution.
Corticosteroids and corticotropin (ACTH): Concurrent use of corticosteroids and corticotropin (ACTH) with amphotericin B may potentiate hypokalemia which could predispose the patient to cardiac dysfunction. If used concomitantly with ABELCET® (amphotericin b) , serum electrolytes and cardiac function should be closely monitored.
Cyclosporin A: Data from a prospective study of prophylactic ABELCET® (amphotericin b) in 22 patients undergoing bone marrow transplantation suggested that concurrent initiation of cyclosporin A and ABELCET® (amphotericin b) within several days of bone marrow ablation may be associated with increased nephrotoxicity.
Digitalis glycosides: Concurrent use of amphotericin B may induce hypokalemia and may potentiate digitalis toxicity. When administered concomitantly with ABELCET® (amphotericin b) , serum potassium levels should be closely monitored.
Flucytosine: Concurrent use of flucytosine with amphotericin B-containing preparations may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion. Flucytosine should be given concomitantly with ABELCET® (amphotericin b) with caution.
Imidazoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.): Antagonism between amphotericin B and imidazole derivatives such as miconazole and ketoconazole, which inhibit ergosterol synthesis, has been reported in both in vitro and in vivo animal studies. The clinical significance of these findings has not been determined.
Leukocyte transfusions: Acute pulmonary toxicity has been reported in patients receiving intravenous amphotericin B and leukocyte transfusions. Leukocyte transfusions and ABELCET® (amphotericin b) should not be given concurrently.
Other nephrotoxic medications: Concurrent use of amphotericin B and agents such as aminoglcosides and pentamidine may enhance the potential for drug-induced renal toxicity. Aminoglycosides and pentamidine should be used concomitantly with ABELCET® (amphotericin b) only with great caution. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications.
Skeletal muscle relaxants: Amphotericin B-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g., tubocurarine) due to hypokalemia. When administered concomitantly with ABELCET® (amphotericin b) , serum potassium levels should be closely monitored.
Zidovudine: Increased myelotoxicity and nephrotoxicity were observed in dogs when either ABELCET® (amphotericin b) (at doses 0.16 or 0.5 times the recommended human dose) or amphotericin B desoxycholate (at 0.5 times the recommended human dose) were administered concomitantly with zidovudine for 30 days. If zidovudine is used concomitantly with ABELCET® (amphotericin b) , renal and hematologic function should be closely monitored.
Read the Abelcet Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/2/2009
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