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adverse reactions
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. 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: Summary of Probably and Possibly Related Adverse Events Reported by ≥ 5% of AMPHOTEC Patients Non-Comparative Studies Comparative Studies [a] Adverse Event AMPHOTEC (n=572) % AMPHOTEC Aspergillosis Patients (n=161) % AMPHOTEC (n=150) % Amphotericin B Deoxycholate (n=146) % Body as a Whole Chills 50 55 77 56 Fever 33 34 55 47 Headache 5 8 4 3 Chills and fever 3 3 7 2 Cardiovascular System Hypotension 10 9 12 5 Tachycardia 10 12 9 5 Hypertension 7 9 7 6 Digestive System Nausea 8 12 7 7 Nausea and vomiting 7 11 4 7 Vomiting 6 8 11 8 Liver function test abnormal 4 4 11 8 Hemic and Lymphatic System Thrombocytopenia 6 7 1 1 Metabolic/Nutritional Disorders Creatinine increased [b] 12 12 21 34 Hypokalemia 8 7 26 29 Hypomagnesemia 4 7 6 11 Hyperbilirubinemia 3 2 19 17 Alkaline phosphatase increased 3 3 7 8 Hyperglycemia 1 1 6 9 Respiratory System Dyspnea 5 4 9 4 Hypoxia 5 6 9 5 [a] From AMPHOTEC (4 or 6 mg/kg/day) and amphotericin B deoxycholate (0.8 or 1 mg/kg/day) patients in prospectively randomized double-blinded studies of empiric treatment of febrile and neutropenic patients or treatment of first-line aspergillosis, respectively. [b] Includes patients with “kidney function abnormal” which was associated with an increase in creatinine. 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 Hematuria 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