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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.

In general, the adverse events most commonly reported with ABELCET® (amphotericin b) were transient chills and/or fever during infusion of the drug.

Adverse Eventsa with an Incidence of ≥ 3% (N=556)

Adverse Event Percentage (%) of Patients
Chills 18
Fever 14
Increased Serum Creatinine 11
Multiple Organ Failure 11
Nausea 9
Hypotension 8
Respiratory Failure 8
Vomiting 8
Dyspnea 7
Sepsis 7
Diarrhea 6
Headache 6
Heart Arrest 6
Hypertension 5
Hypokalemia 5
Infection 5
Kidney Failure 5
Pain 5
Thrombocytopenia 5
Abdominal Pain 4
Anemia 4
Bilirubinemia 4
Gastrointestinal Hemorrhage 4
Leukopenia 4
Rash 4
Respiratory Disorder 4
Chest Pain 3
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.

Body as a whole: malaise, weight loss, deafness, injection site reaction including inflammation

Allergic: bronchospasm, wheezing, asthma, anaphylactoid and other allergic reactions

Cardiopulmonary:cardiac failure, pulmonary edema, shock, myocardial infarction, hemoptysis, tachypnea, thrombophlebitis, pulmonary embolus, cardiomyopathy, pleural effusion, arrhythmias including ventricular fibrillation.

Dermatological: maculopapular rash, pruritus, exfoliative dermatitis, erythema multiforme

Gastrointestinal:acute liver failure, hepatitis, jaundice, melena, anorexia, dyspepsia, cramping, epigastric pain, veno-occlusive liver disease, diarrhea, hepatomegaly, cholangitis, cholecystitis

Hematologic:coagulation defects, leukocytosis, blood dyscrasias including eosinophilia

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

Urogenital: oliguria, decreased renal function, anuria, renal tubular acidosis, impotence, dysuria

Serum electrolyte abnormalities: hypomagnesemia, hyperkalemia, hypocalcemia, hypercalcemia

Liver function test abnormalities: increased AST, ALT, alkaline phosphatase, LDH

Renal function test abnormalities: increased BUN

Other test abnormalities: acidosis, hyperamylasemia, hypoglycemia, hyperglycemia, hyperuricemia, hypophosphatemia