Amphotericin B cholesteryl sulfate adverse reactions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Adverse Reactions
The following adverse events are based on the experience of 572 AMPHOTEC patients from 5 open studies of patients with systemic fungal infections, of whom 526 were treated with a daily dose of 3 - 6 mg/kg. Additionally, comparative adverse event data from 150 AMPHOTEC (4 or 6 mg/kg/day) and 146 amphotericin B deoxycholate (0.8 or 1 mg/kg/day) patients in prospectively randomized doubleblinded studies of empiric treatment of febrile and neutropenic patients or treatment of aspergillosis are also provided.
Infusion-related adverse events: Infusion-related adverse events (1 to 3 hours after starting intravenous infusion) occurred most frequently in association with the first infusion of AMPHOTEC. Their frequency and severity decreased with subsequent dosing. Based on the combined non-comparative studies, 35% (197/569) of the patients reported chills or chills and fever, possibly or probably related to AMPHOTEC, on the first day of dosing, compared to 14% (58/422) by the seventh dose. In the comparative studies, a similar decreasing trend was noted for AMPHOTEC and amphotericin B deoxycholate.
More Common Adverse Events
Adverse events that were considered to be possibly or probably related to AMPHOTEC and that occurred in 5% or more of the patients are summarized in the table below:
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Additionally, the following adverse events also occurred in 5% or more of AMPHOTEC patients; however, the causal relationship of these adverse events is uncertain:
General (body as a whole)
Abdomen enlarged, abdominal pain, back pain, chest pain, face edema, injection site inflammation, mucous membrane disorder, pain, sepsis
Cardiovascular System
Cardiovascular disorder, hemorrhage, postural hypotension
Digestive System
Diarrhea, dry mouth, hematemesis, jaundice, stomatitis
Hemic and Lymphatic System
Anemia, coagulation disorder, prothrombin decreased
Metabolic and Nutritional Disorders
Edema, generalized edema, hypocalcemia, hypophosphatemia, peripheral edema, weight gain
Nervous System
Confusion, dizziness, insomnia, somnolence, thinking abnormal, tremor
Respiratory System
Apnea, asthma, cough increased, epistaxis, hyperventilation, lung disorder, rhinitis
Skin and Appendages
Maculopapular rash, pruritis, rash, sweating
Special Senses
Eye hemorrhage
Urogenital
Less Common Adverse Events
The following adverse events occurred in 1% to less than 5% of AMPHOTEC patients. The causal association between these adverse events and AMPHOTEC is uncertain.
General (body as a whole)
Accidental injury, allergic reaction, asthenia, death, hypothermia, immune system disorder, infection, injection site pain, injection site reaction, neck pain
Cardiovascular System
Arrhythmia, atrial fibrillation, bradycardia, congestive heart failure, heart arrest, phlebitis, shock, supraventricular tachycardia, syncope, vasodilatation, venoocclusive liver disease, ventricular extrasystoles
Digestive System
Anorexia, bloody diarrhea, constipation, dyspepsia, fecal incontinence, gamma glutamyl transpeptidase increased, gastrointestinal disorder, gastrointestinal hemorrhage, gingivitis, glossitis, hepatic failure, melena, mouth ulceration, oral moniliasis, rectal disorder
Hemic and Lymphatic System
Ecchymosis, fibrinogen increased, hypochromic anemia, leukocytosis, leukopenia, petechia, thromboplastin decreased
Metabolic and Nutritional Disorders
Acidosis, BUN increased, dehydration, hyponatremia, hyperkalemia, hyperlipemia, hypernatremia, hypervolemia, hypoglycemia, hypoproteinemia, lactic dehydrogenase increased, AST (SGOT) increased, ALT (SGPT) increased, weight loss
Musculoskeletal System
Arthralgia, myalgia
Nervous System
Agitation, anxiety, convulsion, depression, hallucinations, hypertonia, nervousness, neuropathy, paresthesia, psychosis, speech disorder, stupor
Respiratory System
Hemoptysis, lung edema, pharyngitis, pleural effusion, respiratory disorder, sinusitis
Skin and Appendages
Acne, alopecia, petechial rash, skin discoloration, skin disorder, skin nodule, skin ulcer, urticaria, vesiculobullous rash
Special Senses
Amblyopia, deafness, ear disorder, tinnitus
Urogenital System
Albuminuria, dysuria, glycosuria, kidney failure, oliguria, urinary incontinence, urinary retention, urinary tract disorder.[1]
References
Adapted from the FDA Package Insert.