ADVERSE REACTIONS The total safety data base is composed of 921 patients treated with ABELCET® (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®, 9% discontinued treatment due to adverse events regardless of presumed relationship to study drug. In general, the adverse events most commonly reported with ABELCET® 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 Cardiac Arrest 6 Hypertension 5 Hypokalemia 5 Infection 5 Kidney Failure 5 Pain 5 Thrombocytopenia 5 Anemia 4 Hyperbilirubinemia 4 Gastrointestinal Hemorrhage 4 Leukopenia 4 Rash 4 Respiratory Disorder 4 Chest Pain 3 Nausea and Vomiting 3 aThe causal association between these adverse events and ABELCET® is uncertain. The following adverse events have also been reported in patients using ABELCET® in open-label, uncontrolled clinical studies. The causal association between these adverse events and ABELCET® 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 To report SUSPECTED ADVERSE REACTIONS, contact Sigma-Tau Pharmaceuticals, Inc. at 1-888-393-4584 or by email at [email protected]
or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.