Amphotec Side Effects

Please note - some side effects for Amphotec may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Amphotec - for the Consumer

Amphotec

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amphotec:

Chills; fever; headache; loss of appetite; muscle or joint pain; nausea; stomach pain; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Amphotec:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; convulsions; dark, bloody stools; decreased urination; diarrhea; dizziness; fast breathing; hearing loss; irregular heartbeat; pain or redness at the injection site; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Amphotec Side Effects - for the Professional

Amphotec

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) %
[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
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

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

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Side Effects by Body System - for Healthcare Professionals

General

General reactions such as fever and chills/rigors have been reported in 35% of patients. These symptoms usually begin within 1 to 3 hours of initiation of an amphotericin B cholesteryl sulfate infusion and diminish with subsequent infusions. Slowing the rate of infusion may control symptoms. Severe infusion-related side effects associated with conventional amphotericin B administration have been lessened by pretreatment/treatment with corticosteroids, acetaminophen, antihistamines, and meperidine.

Renal

Renal toxicity has been reported less frequently with amphotericin B cholesteryl sulfate than with conventional amphotericin B. Increased serum creatinine, BUN, and hypokalemia have occurred in patients receiving amphotericin B cholesteryl sulfate. Acute kidney failure, abnormal renal function including oliguria, albuminuria, dysuria, glycosuria, and urinary incontinence and retention have been reported.

Metabolic

Metabolic changes have occurred less frequently with amphotericin B cholesteryl sulfate than with conventional amphotericin B. Decreased serum concentrations of potassium, magnesium, sodium, and calcium often accompany amphotericin-induced nephrotoxicity and patients may require replacement therapy. Hyperglycemia, hypervolemia, and weight gain/loss have been reported.

Gastrointestinal

Common gastrointestinal side effects, including nausea, vomiting, and diarrhea have been reported. Gastrointestinal hemorrhage, abdominal pain, stomatitis, anorexia, dyspepsia, epigastric pain, cramping, malaise, and constipation have occurred less frequently.

Hematologic

Hematologic abnormalities associated with amphotericin B lipid complex therapy have occurred infrequently. Thrombocytopenia, anemia, coagulation defects, and altered leukocyte counts have been reported.

Nervous system

Nervous system side effects including headache, insomnia, anxiety, and confusion, convulsions, coma, peripheral neuropathy, and somnolence have occurred.

Hypersensitivity

Hypersensitivity may present as bronchospasm, wheezing, or anaphylactoid reactions. Cell mediated immunological reactions have occurred.

Cardiovascular

Cardiac side effects (primarily infusion-related) have occurred in approximately 9% of patients receiving amphotericin B cholesteryl sulfate. Side effects have included hypertension, hypotension, and tachycardia. Cardiac failure/arrest, chest pain, vasodilation, cardiomyopathy, and arrhythmias have been reported infrequently.

Respiratory

Infusion-related respiratory side effects have included dyspnea, and hypoxia. Increased cough, rhinitis, respiratory insufficiency/failure, hyperventilation, pneumonia, asthma, hemoptysis, and lung edema have been reported in treated patients.

Dermatologic

Dermatologic side effects have included alopecia, dry skin, skin discoloration, maculopapular rash, pruritus, sweating, flushing, and ulceration.

Local

Local inflammation at the injection site has been reported.

Musculoskeletal

Musculoskeletal side effects have included generalized bone, joint, or muscle pain.

Hepatic

Hepatic side effects associated with amphotericin B cholesteryl sulfate therapy have included elevated serum concentrations of alkaline phosphatase, ALT, AST, and bilirubin. Hepatocellular toxicity, hepatomegaly, and veno-occlusive liver disease have been reported.

Genitourinary

Rare genitourinary side effects have included hematuria and vaginal bleeding.

Psychiatric

Psychiatric side effects have included depression, hallucinations, and abnormal thought processes.

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