(ep i roo' bi sin)

Brand Name(s): Ellence^®; also available generically

IMPORTANT WARNING:

Epirubicin should be administered only into a vein. However, it may leak into surrounding tissue causing severe irritation or damage. Your doctor or nurse will monitor your administration site for this reaction. If you experience any of the following symptoms, call your doctor immediately: pain, itching, redness, swelling, blisters, or sores in the place where the medication was injected.

Epirubicin may cause serious or life-threatening heart problems at any time during your treatment or months to years after your treatment has ended. Your doctor will order tests before and during your treatment to see if your heart is working well enough for you to safely receive epirubicin. These tests may include an electrocardiogram (ECG; test that records the electrical activity of the heart) and an echocardiogram (test that uses sound waves to measure your heart's ability to pump blood). Your doctor may tell you that you should not receive this medication if the tests show your heart's ability to pump blood has decreased. Tell your doctor if you have or have ever had any type of heart disease or radiation (x-ray) therapy to the chest area. Tell your doctor and pharmacist if you are taking or have ever received certain cancer chemotherapy medications such as daunorubicin (Cerubidine), doxorubicin (Doxil), idarubicin (Idamycin), mitoxantrone (Novantrone), cyclophosphamide (Cytoxan), or trastuzumab (Herceptin). If you experience any of the following symptoms, call your doctor immediately: shortness of breath; difficulty breathing; swelling of the hands, feet, ankles or lower legs; or fast, irregular, or pounding heartbeat.

Epirubicin may increase your risk for developing leukemia (cancer of the white blood cells), especially when it is given in high doses or together with certain other chemotherapy medications.

Epirubicin can cause a severe decrease in the number of blood cells in your bone marrow. This may cause certain symptoms and may increase the risk that you will develop a serious infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising.

Epirubicin should be given only under the supervision of a doctor with experience in the use of chemotherapy medications.

Talk to your doctor about the risk(s) of receiving epirubicin.

WHY is this medicine prescribed?

Epirubicin is used in combination with other medications to treat breast cancer in patients who have had surgery to remove the tumor. Epirubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Epirubicin comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a medical facility along with other chemotherapy medications. It may be injected once every 21 days for 6 cycles of therapy or it may be injected twice (on days 1 and 8) every 28 days for six cycles of therapy.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving epirubicin injection,

• tell your doctor and pharmacist if you are allergic to epirubicin, daunorubicin (Cerubidine, DaunoXome), doxorubicin (Doxil), idarubicin (Idamycin), any other medications, or any of the ingredients in epirubicin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving epirubicin injection.Your doctor may need to change the doses of your medications or monitor you carefully for side effects. .

• the following nonprescription product may interact with epirubicin injection: cimetidine. Be sure to let your doctor and pharmacist know that you are taking these medications before you start receiving epirubicin injection. Do not start any of these medications while receiving epirubicin injection without discussing with your healthcare provider.

• tell your doctor if you previously received radiation therapy or have or have ever had liver or kidney disease.

• you should know that epirubicin may interfere with the normal menstrual cycle (period) in women and may stop sperm production in men. However, you should not assume that you cannot get pregnant or that you cannot get someone else pregnant. Women who are pregnant or breast-feeding should tell their doctors before they begin receiving this drug. You should not become pregnant or breast-feed while you are receiving epirubicin injection. If you become pregnant while receiving epirubicin, call your doctor. Talk to your doctor about birth control methods to use during your treatment. Epirubicin may harm the fetus.

• do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Epirubicin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• sores in the mouth and throat
• stomach pain
• diarrhea
• loss of appetite or weight
• unusual tiredness or weakness
• hair loss
• hot flashes
• red discoloration of urine (for 1 to 2 days after dose)
• sore or red eyes
• eye pain
• darkening of the skin or nails

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• pale skin
• fainting
• dizziness
• rash
• hives
• itching
• difficulty breathing or swallowing

Epirubicin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• sores in the mouth and throat
• fever, sore throat, chills, or other signs of infection
• unusual bleeding or bruising
• black and tarry stools
• red blood in stools
• bloody vomit
• vomited material that looks like coffee grounds

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to epirubicin.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 20, 2024.