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Amphotec (Amphotericin B) - Side Effects and 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 StudiesComparative Studies [a]

Adverse
Event
AMPHOTEC
(n=572)
%
AMPHOTEC
Aspergillosis
Patients
(n=161)
%
AMPHOTEC
(n=150)
%
Amphotericin B
Deoxycholate
(n=146)
%
[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.
Body as a Whole
     Chills50557756
     Fever33345547
     Headache5843
     Chills and fever3372
Cardiovascular System
     Hypotension 109125
     Tachycardia 101295
     Hypertension7976
Digestive System
     Nausea81277
     Nausea and vomiting71147
     Vomiting68118
     Liver function test abnormal44118
Hemic and Lymphatic System
     Thrombocytopenia6711
Metabolic/Nutritional Disorders
     Creatinine
increased [b]
12122134
     Hypokalemia 872629
     Hypomagnesemia47611
     Hyperbilirubinemia321917
     Alkaline phosphatase increased3378
     Hyperglycemia 1169
Respiratory System
     Dyspnea5494
     Hypoxia5695

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

Drug label data at the top of this Page last updated: 2006-02-27

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