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Ellence®

Brand Name: Ellence®
Active Ingredient:   epirubicin
Strength(s): 50 mg/25 ml & 200 mg/100 ml single-use vials
Dosage Form(s):   Intravenous injection
Company Name:    Pharmacia & Upjohn Co.
Availability:         Prescription only
*Date Approved by FDA:   September 15, 1999
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Ellence used for? 

Ellence is used together with other chemotherapy drugs to treat breast cancer that has spread to the lymph nodes under the arm following breast cancer surgery.

Who should not be given Ellence? 

You should not be given Ellence if you have had any of the following conditions:

  • Low levels of white blood cells in the body
  • Severe heart failure
  • Recent heart attack
  • Treatment in the past with this class of drugs (anthracyclines) up to the maximum total dose
  • Allergic reactions to Ellence or other similar medications
  • Severe liver problems

Special Warning(s) with Ellence:

Side effects involving the heart are a known risk of treatment with this class of drugs. Side effects may occur during treatment or even after you have stopped taking Ellence. Discuss with your doctor the possible short and long-term side effects of being given Ellence.

Treatment with Ellence can cause leukemia, which may not be seen for up to 3 years following treatment. Talk to your doctor about follow-up medical examinations.

If you have liver problems, your doctor will decide if Ellence is right for you.

Ellence may temporarily cause a decrease in your body’s ability to produce bone marrow, which is needed to form several components of the blood.

General Precautions with Ellence: 

Ellence may cause premature menopause in women.

What should I tell my doctor or health care provider? 

Because certain other medications can interact with Ellence, review all medications that you are taking with your health care provider, including those that you take without a prescription.

Tell your doctor right away about any side effects you experience. Ellence, when used with certain other medications, may show a combined increase in side effects. Some examples of these types of medications are:

  • Chemotherapy medications
  • Medications that could cause heart failure (e.g., calcium channel blockers)
  • Cimetidine

If you have been treated with radiation in the past, Ellence may cause an inflammation reaction (swelling, tenderness, or redness) at the site of that treatment.

Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding. Because Ellence may cause birth defects, women of childbearing age should avoid becoming pregnant and stop nursing while taking Ellence.

Men and women being treated with Ellence should use effective birth control methods, because Ellence can cause damage to men’s sperm and can cause damage to the unborn baby in women.

What are some possible side effects of Ellence? (This is NOT a complete list of side effects reported with Ellence. Your health care provider can discuss with you a more complete list of side effects.)   

Tell your doctor if you experience any of the following possible side effects while being treated with Ellence:

  • Nausea
  • Vomiting
  • Diarrhea
  • Mouth sores
  • Dehydration (lack of fluids)
  • Fever
  • Signs of infection
  • Symptoms of congestive heart failure (such as ankle swelling, shortness of breath)
  • Pain, burning or stinging at the injection site

Do not be concerned if your urine appears red for 1-2 days after being given Ellence.

Other side effects include:

  • Hair loss (usually reversible after treatment is finished)
  • Low red blood cell counts (anemia)
  • Temporary or permanent loss of menstrual cycle in women
  • Feeling tired
  • Hot flashes
  • Rash/Itch

For more detailed information about Ellence, ask your health care provider.

http://www.fda.gov/cder/foi/label/1999/50778lbl.pdf    Link to Ellence's Approved Label 

Posted: 5/8/00
Revised: 3/15/01

 

Back to Drug Side Effects


source: FDA


last update: December 2004





This information is not intended to be a substitute for professional medical advice. You should not use this material to diagnose or treat a health condition or disease without consulting with your healthcare provider.
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