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Amphotericin b cholesteryl sulfate Side Effects

For the Consumer

Applies to amphotericin b cholesteryl sulfate: intravenous suspension reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Shortness of breath.
  • Fever or chills.
  • Very bad dizziness or passing out.
  • Fast breathing.
  • A fast heartbeat.
  • Very bad headache.
  • Any unexplained bruising or bleeding.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Diarrhea.
  • Not hungry.
  • Weight loss.
  • Muscle pain.
  • Joint pain.
  • Belly pain.
  • Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to amphotericin b cholesteryl sulfate: intravenous powder for injection

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Hematologic

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

Nervous system

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

Hypersensitivity

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

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.[Ref]

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.[Ref]

Dermatologic

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

Local

Local inflammation at the injection site has been reported.[Ref]

Musculoskeletal

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

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.[Ref]

Genitourinary

Rare genitourinary side effects have included hematuria and vaginal bleeding.[Ref]

Psychiatric

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

References

1. "Product Information. Amphotec (amphotericin B cholesteryl sulfate)." Sequus Pharmaceuticals Inc, Menlo Park, CA.

2. Brogden RN, Goa KL, Coukell AJ "Amphotericin-B colloidal dispersion: A review of its use against systemic fungal infections and visceral leishmaniasis." Drugs 56 (1998): 365-83

3. Kauffman CA, Wiseman SW "Anaphylaxis upon switching lipid-containing amphotericin B formulations." Clin Infect Dis 26 (1998): 1237-8

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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