Abelcet Side Effects

Please note - some side effects for Abelcet 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 Abelcet - for the Consumer

Abelcet

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 Abelcet:

Chills; coughing; fever; headache; loss of appetite; muscle or joint pain; nausea; rapid heartbeat; sleeplessness; stomach pain; weight loss.

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

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

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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Abelcet Side Effects - for the Professional

Abelcet

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.

Adverse Eventsa with an Incidence of ≥3% (N=556)
Adverse Event	Percentage (%) of Patients
Chills	18
Fever	14
Increased Serum Creatinine	11
Multiple Organ Failure	11
Nausea	9
Hypotension	8
Respiratory Failure	8
Vomiting	8
Dyspnea	7
Sepsis	7
Diarrhea	6
Headache	6
Heart Arrest	6
Hypertension	5
Hypokalemia	5
Infection	5
Kidney Failure	5
Pain	5
Thrombocytopenia	5
Anemia	4
Bilirubinemia	4
Gastrointestinal Hemorrhage	4
Leukopenia	4
Rash	4
Respiratory Disorder	4
Chest Pain	3
Nausea and Vomiting	3

 aThe causal association between these adverse events and Abelcet® is uncertain.

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.

Body as a whole: malaise, weight loss, deafness, injection site reaction including inflammation

Allergic: bronchospasm, wheezing, asthma, anaphylactoid and other allergic reactions

Cardiopulmonary: cardiac 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: coagulation defects, 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.

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Side Effects by Body System - for Healthcare Professionals

General

General side effects during infusions have included fever (15%), chills (15%), and shivering. These symptoms usually begin 1 to 2 hours after the beginning of an amphotericin B lipid complex infusion, and are more common with the first few doses administered.

Severe infusion-related side effects have been associated with conventional amphotericin B administration, and may be lessened by treatment with corticosteroids, acetaminophen, antihistamines, and meperidine.

Renal

Renal side effects have been reported less frequently with amphotericin B lipid complex than with conventional amphotericin B, and often included increased serum creatinine and BUN. Renal failure occurred in about 5% of treated patients. Decreased renal function, including oliguria, anuria, and renal tubular acidosis have also been reported.

Metabolic

Metabolic side effects have occurred less frequently with amphotericin B lipid complex than with conventional amphotericin B. Hypokalemia and hypomagnesemia often accompany amphotericin-induced nephrotoxicity. Hypocalcemia has also been reported in treated patients.

Gastrointestinal

Gastrointestinal (GI) side effects, including nausea, vomiting, or diarrhea in 5% to 8% of patients, have been associated with amphotericin B lipid complex infusions. GI hemorrhage, abdominal pain, anorexia, dyspepsia, epigastric pain, cramping, malaise, and weight loss have occurred less frequently.

Hematologic

Hematologic side effects have included thrombocytopenia, leukopenia, anemia, and less frequently, coagulation defects, blood dyscrasias, and leukocytosis.

Nervous system

Nervous system side effects have been reported rarely, except for headache, which occurred in about 4% of treated patients. Less frequently, convulsions, peripheral neuropathy visual impairment, including diplopia, hearing loss, tinnitus, and transient vertigo have been reported.

Hypersensitivity

Hypersensitivity side effects have been reported. These may present as bronchospasm, wheezing, or anaphylactoid reactions. Erythema multiforme has also been reported.

Cardiovascular

Cardiovascular side effects including cardiac arrest and hypotension have been reported in 6% to 8% of treated patients. Hypertension, cardiac failure, cardiomyopathy, arrhythmias, and ventricular fibrillation have been uncommonly reported.

Respiratory

Respiratory side effects including respiratory failure, dyspnea, pneumonia, or other respiratory disorders have been reported in treated patients.

Dermatologic

Dermatologic side effects have included maculopapular rash, pruritus, and exfoliative dermatitis. Exanthema has been reported in a patient who was treated concomitantly with amphotericin B lipid complex and imipenem-cilastatin. The exact cause is unknown.

Local

Local side effects including thrombophlebitis and inflammation at the injection site have been reported.

Musculoskeletal

Musculoskeletal side effects including generalized bone, joint, or muscle pain have been reported.

Hepatic

Hepatic side effects have been uncommonly reported. These have included liver failure, jaundice, hepatitis, and increased AST, ALT, and alkaline phosphatase levels.

Genitourinary

Genitourinary side effects have rarely included impotence.

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