Amphotericin B adverse reactions: Difference between revisions
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==Adverse Reactions== | ==Adverse Reactions== | ||
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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. | 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.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5587db37-f21a-4a39-a319-e1077032ced9 | publisher = | date = | accessdate = }}</ref> | In general, the adverse events most commonly reported with ABELCET® were transient chills and/or fever during infusion of the drug. | ||
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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. | |||
'''General''': [[malaise]], [[weight loss]], [[deafness]], injection site reaction including [[inflammation]] | |||
'''Allergic''': [[bronchospasm]], [[wheezing]], [[asthma]], [[anaphylactoid]] and other allergic reactions | |||
'''Cardiopulmonary''': [[heart 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''': [[coagulopathy]], [[leukocytosis]], blood [[dyscrasia]]s 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 drugsafety@sigmatau.com or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ABELCET (AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) INJECTION [SIGMA-TAU PHARMACEUTICALS, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5587db37-f21a-4a39-a319-e1077032ced9 | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Latest revision as of 04:57, 12 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
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.
 |
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.
General: malaise, weight loss, deafness, injection site reaction including inflammation
Allergic: bronchospasm, wheezing, asthma, anaphylactoid and other allergic reactions
Cardiopulmonary: heart 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: coagulopathy, 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 drugsafety@sigmatau.com or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.[1]
References
Adapted from the FDA Package Insert.