IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

EPIRUBICIN HYDROCHLORIDE - INJECTION

(epp-ih-REWB-ih-sin)

COMMON BRAND NAME(S): Ellence

WARNING: Epirubicin must only be injected slowly and directly into a vein (IV) through other intravenous (IV) fluids. Do not inject this medication into the muscle (IM) or just beneath the skin (subcutaneously). If this medication accidentally leaks into surrounding tissue, the skin and/or muscle may be severely damaged. Notify your doctor immediately if redness, pain, or swelling occur at or around the injection site. Epirubicin may cause heart problems (including heart failure), bone marrow suppression, or other types of cancer (acute myelogenous leukemia). Notify your doctor immediately if you develop: irregular heartbeat, trouble breathing, swelling of the hands and feet, easy bruising or bleeding, dry cough, signs of infection (e.g., fever, unusual fatigue, or persistent sore throat). Heart problems may occur during therapy or sometimes months to years after receiving this medication. The risk of developing heart problems or leukemia varies depending on your dose, condition, and other medications. Tell your doctor if you have liver problems before starting treatment with this medication. You may require smaller doses of epirubicin.

USES: Epirubicin is used to treat breast cancer. It works by eliminating or stopping the growth of cancer cells.

HOW TO USE: Inject this medication into a vein (IV) through other IV fluids (e.g., saline, dextrose), usually over three to five minutes; or as directed by your doctor. Follow all instructions for proper mixing and dilution with the correct IV fluids. Ask your pharmacist if you have questions regarding the use of this medication. To minimize serious side effects, you may be given other medications (e.g., antiemetics, antibiotics) in addition to this drug. Follow all directions for the proper use of other medications. Consult your doctor or pharmacist if you have questions regarding the use of additional medications. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

SIDE EFFECTS: Nausea, hair loss, diarrhea, or stomach pain may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly. This medication may cause your urine to turn red in color. This is a normal effect of the drug. It is temporary and should disappear in one to two days. Notify your doctor if this effect persists longer than two days. Tell your doctor immediately if any of these serious side effects occur: pain or redness at the injection site, easy bruising or bleeding, persistent sore throat or fever, unusual tiredness, flushing, changes in menstrual period, eye problems, sores in the mouth or throat. Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/slow/irregular heartbeat, unexplained weight gain, bloating, loss of appetite, joint pain, sun sensitivity, changes in the appearance of the skin. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: previous chemotherapy or radiation treatments, kidney problems, allergies (especially to anthracyclines such as daunorubicin or doxorubicin, or anthracenediones such as mitoxantrone). This medication is not recommended for use if you have any of the following medical conditions: bone marrow suppression (e.g., leukopenia, neutropenia), heart problems (e.g., congestive heart failure, myocardial infarction), liver problems. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, use a sunscreen, and wear protective clothing when outdoors. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug. Because this medication may effect the production of sperm, it is recommended that men undergoing treatment with this drug use effective contraceptive methods (e.g., condoms). Consult your doctor or pharmacist for details. This medication can interfere with the menstrual cycle and cause premature menopause (change of life). Consult your doctor or pharmacist for details. This medication is not recommended for use during pregnancy. Consult your doctor for more details. Based on information of related drugs, this medication may pass into breast milk. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast- feeding.

DRUG INTERACTIONS: Tell your doctor or pharmacist of all prescription and nonprescription drugs you may use, especially of: other cancer chemotherapy (e.g., daunorubicin, doxorubicin), calcium channel blockers (e.g., diltiazem, nifedipine, verapamil), beta-blockers (e.g., atenolol, metoprolol), cimetidine. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include black stool, coffee ground-like vomit, trouble breathing, change in amount of urine.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., blood counts) will be performed to monitor for side effects and response to treatment.

MISSED DOSE: If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. If the dose is interrupted, contact your doctor or pharmacist immediately to establish new dosing.

STORAGE: Store vials at refrigerator temperature between 36 and 46 degrees F (2 and 8 degrees C) away from light and moisture. Do not freeze. Discard unused portion.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

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Copyright 2004 by First DataBank, Inc.