Generic Name: epirubicin (EP-i-ROO-bi-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 (eg, heart failure). These problems may occur during therapy or sometimes months to years after receiving Ellence. The risk may be increased if you are using certain medicines that may affect heart function (eg, trastuzumab), or have a history of heart problems, radiation treatment to the chest area, or previous therapy with other anthracyclines (eg, doxorubicin). The risk of developing heart problems varies depending on your dose and condition, although it can occur at any dose whether or not you are at risk. Notify your doctor immediately if you develop fast, slow, or irregular heartbeat; shortness of breath; sudden, unexplained weight gain; or swelling of the hands, ankles, or feet.
Another type of cancer (acute myelogenous leukemia [AML]) has been reported in patients with breast cancer treated with anthracyclines, including Ellence. The risk of developing AML varies depending on your dose and other medicines. Discuss any questions or concerns with your doctor.
Ellence may cause bone marrow suppression. Notify your doctor immediately if you develop easy bruising or bleeding, unusual tiredness or weakness, or signs of an infection (eg, fever, chills, persistent sore throat).
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 killing cancer cells. The exact way Ellence works is not fully understood.
Do NOT use Ellence if:
- you are allergic to any ingredient in Ellence, to similar medicines (eg, doxorubicin), or to mitoxantrone
- you have very low white blood cell levels
- you have heart failure, heart muscle problems, or a severe irregular heartbeat, or recently had a heart attack
- you have severe liver disease
- you have taken or will be taking palifermin within 24 hours before or after using Ellence
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, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- 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, an infection, bone marrow problems (eg, low blood platelet levels, low white blood cell levels), or mouth or tongue sores or swelling (stomatitis)
- if you have a history of heart problems (eg, heart block, irregular heartbeat) or radiation treatment, or if you have previously received Ellence or similar medicines (eg, doxorubicin, daunorubicin)
- if you are taking medicines that may affect heart function (eg, calcium channel blockers, trastuzumab). Ask your doctor if you are unsure if any of your medicines may affect heart function
Some MEDICINES MAY INTERACT with Ellence. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Calcium channel blockers (eg, diltiazem, verapamil) or trastuzumab because the risk of heart problems (eg, heart failure) may be increased
- Cimetidine, cyclosporine, docetaxel, or paclitaxel because they may increase the risk of Ellence's side effects
- Palifermin because if mouth or tongue sores develop, they may be more severe or last longer
- Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Ellence
- Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of Ellence's side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
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.
- Do not use Ellence if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.
- Do not take cimetidine while you are taking Ellence.
- 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 protective clothing (eg, gloves, goggles, gowns) while handling Ellence is recommended.
- If you miss a dose of Ellence, contact your doctor right away.
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.
- Tell your doctor or dentist that you take Ellence before you receive any medical or dental care, emergency care, or surgery.
- Ellence may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Ellence may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Ellence may cause a serious and possibly fatal condition called tumor lysis syndrome (TLS). Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness. Discuss any questions or concerns with your doctor.
- Ellence may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Ellence. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Ellence. Talk with your doctor before you receive any vaccine.
- Lab tests, including blood counts, liver and kidney function tests, and heart function tests, may be performed while you use Ellence. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Ellence with caution in the ELDERLY, especially elderly women; they may be more sensitive to its effects.
- Ellence should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- Caution is advised when using Ellence in CHILDREN; they may be more sensitive to its effects, especially heart problems (eg, heart failure).
- If you may become pregnant, you must use an effective form of birth control while you take Ellence. If you have questions about effective birth control, talk with your doctor.
- Ellence may damage sperm. Use effective birth control methods (eg, condoms) while using Ellence. Discuss any questions or concerns with your doctor.
- Women taking Ellence may develop absence of menstrual periods or early menopause.
- PREGNANCY and BREAST-FEEDING: Ellence may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ellence while you are pregnant. It is not known if this medicine is found 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; hair loss; hot flashes; menstrual period changes; nausea; skin changes; tiredness.
Severe allergic reactions (rash; hives; itching; 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; chest pain; coughing up blood; facial flushing; fast, slow, or irregular heartbeat; fever, chills, or persistent cough or sore throat; itching, pain, redness, or swelling at the injection site; redness or discharge of the eyes; shortness of breath; stomach pain or tenderness; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; swelling or soreness of the mouth or tongue; symptoms of dehydration (eg, dry mouth or eyes, decreased urination, fast heartbeat, sluggishness, unusual thirst); tenderness, pain, redness, or swelling of an arm or leg; unusual bruising or bleeding; unusual tiredness or weakness; vomiting.
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.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry, or bloody stools; difficulty urinating; fast or irregular heartbeat; shortness of breath; stomach pain or tenderness; swelling or soreness of the mouth or tongue; vomit that looks like coffee grounds; vomiting.Proper storage of Ellence:
Ellence is usually handled and stored by a health care provider. If you are using Ellence at home, store Ellence as directed by your pharmacist or health care provider. Keep Ellence out of the reach of children and away from pets.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Ellence or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ellence. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ellence. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Ellence.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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Other brands: Pharmorubicin PFS