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