Ellence

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Ellence


Generic Name: Epirubicin (EH-pih-ROO-bih-sin)
Brand Name: Ellence

Ellence is for injection into a vein only and should only be given under the supervision of a doctor experienced in the use of cancer chemotherapy agents. If Ellence accidentally leaks into surrounding tissue, the skin and/or muscle may be severely damaged. Notify your doctor at once if redness, pain, or swelling occurs at or around the injection site. Ellence may cause heart problems (including heart failure), bone marrow suppression, or other types of cancer (eg, acute myelogenous leukemia). Notify your doctor immediately if you develop an irregular heartbeat, trouble breathing, swelling of the hands and feet, easy bruising or bleeding, dry cough, or signs of an infection, such as fever, unusual fatigue, or persistent sore throat. Heart problems may occur during therapy or for months to years after receiving this medicine. The risk of developing heart problems or leukemia varies depending on your dose, condition, and other medicines. Tell your doctor if you have liver problems before starting treatment with Ellence . You may require smaller doses of Ellence .


Ellence is used for:

Treating certain types of breast cancer following surgery. It may also be used to treat other cancers as determined by your doctor.

Ellence is an antineoplastic. It works by interfering with the growth of cancer cells, making it easier for the body to kill them. The exact way Ellence works is not fully understood.

Do NOT use Ellence if:

  • you are allergic to any ingredient in Ellence or to similar medicines
  • you have a decreased blood cell count from other cancer medicines or radiation treatment
  • you have severe heart problems, abnormal heart rhythms, a history of heart insufficiency, or recently had a heart attack
  • you have severe liver disease
  • you have taken similar medicines (eg, anthracyclines) in the past

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ellence :

Some medical conditions may interact with Ellence . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, plan to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems, heart problems, or an infection

Some MEDICINES MAY INTERACT with Ellence . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Cimetidine, cyclosporine, or thiazide diuretics (eg, hydrochlorothiazide) because side effects such as decreased ability to fight infections and decreased blood cell counts may occur
  • Trastuzumab because side effects such as heart problems may occur
  • Carbamazepine, hydantoins (eg, phenytoin), quinolones (eg, ciprofloxacin), or valproic acid because effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ellence may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ellence :

Use Ellence as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

  • Ellence is usually administered as an injection at your doctor"s office, hospital, or clinic. Ask your doctor any questions that you may have about Ellence .
  • If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.
  • If Ellence accidentally spills on your skin, wash it off immediately with soap and water for approximately 15 minutes. Contact your doctor as soon as possible. The use of gloves while handling Ellence is recommended.
  • If you miss a dose of Ellence , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Ellence .

Important safety information:

  • Urine may appear red for 1 to 2 days after administration of Ellence . This is to be expected.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ellence .
  • Ellence may reduce the number of blood cells that are needed for clotting. To prevent bleeding, avoid situations where bruising or injury may occur.
  • Ellence may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection including fever, sore throat, rashes, or chills. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first.
  • Check with your doctor before having immunizations (vaccinations).
  • LAB TESTS, including blood counts and liver function tests, will be required to monitor therapy. Be sure to keep appointments.
  • Ellence is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
  • Ellence may damage sperm. Use effective birth control methods (eg, condoms) while using Ellence .
  • Women taking Ellence may develop absence of menstrual periods or early menopause.
  • PREGNANCY and BREAST-FEEDING: Ellence has been shown to cause harm to the human fetus. Do not become pregnant while using Ellence . If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Ellence during pregnancy. It is unknown if Ellence is excreted in breast milk. Do not breast-feed while taking Ellence .

Possible side effects of Ellence :

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:

Changes in menstrual periods; diarrhea; hair loss; hot flashes; loss of appetite; nausea; red-colored urine; skin changes; tiredness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); absence of menstrual cycle; black, tarry stools; blood in the urine or stools; burning, stinging, or pain during or after the injection of Ellence ; chills; cough; dehydration; facial flushing; fast or irregular heartbeat; fever; joint pain; itching; pain, redness, or swelling at the injection site; redness or discharge of the eyes; shortness of breath; stomach pain or tenderness; sore throat; sores on the mouth, nose, or lips; swelling of the ankles or feet; unusual bruising or bleeding; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include black, tarry stools; bloody stools; difficulty urinating; fast or irregular heartbeat; shortness of breath; stomach pain or tenderness; vomiting.

Proper storage of Ellence :

Store Ellence as directed on the prescription label. Keep Ellence out of the reach of children and away from pets.

General information:

  • If you have any questions about Ellence , please talk with your doctor, pharmacist, or other health care provider.
  • Ellence is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ellence . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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