What is this medication?

EPIRUBICIN (ep i ROO bi sin) is a chemotherapy drug. This medicine is used to treat breast cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Ellence

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• heart disease
• history of irregular heartbeat
• history of low blood counts caused by a medicine
• kidney disease
• liver disease
• recent heart attack
• recent or ongoing radiation therapy
• recently received or scheduled to receive a vaccine
• an unusual or allergic reaction to epirubicin, other chemotherapy agents, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a healthcare professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

This medicine may interact with the following medications:

• calcium channel blockers
• cimetidine
• docetaxel
• paclitaxel
• trastuzumab
• live virus vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work done while you are taking this medicine.

This medicine may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your healthcare professional tells you to stop.

Your urine may turn red for a few days after your dose. This is not blood. If your urine is dark or brown, call your doctor.

This medicine may increase your risk of getting an infection. Call your healthcare professional for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. Call your healthcare professional if you are around anyone with measles, chickenpox, or if you develop sores or blisters that do not heal properly.

Call your healthcare professional for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This medicine decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your healthcare professional. These medicines may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Do not become pregnant while taking this medicine or for 6 months after stopping it. Women should inform their healthcare professional if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 3 months after stopping it. There is potential for serious side effects to an unborn child. Talk to your healthcare professional for more information.

Do not breast-feed an infant while taking this medicine or for at least 7 days after stopping it.

This medicine has caused ovarian failure in some women. This medicine may make it more difficult to get pregnant. Talk to your healthcare professional if you are concerned about your fertility.

This medicine has caused decreased sperm counts in some men. This may make it more difficult to father a child. Talk to your healthcare professional if you are concerned about your fertility.

There is a maximum amount of this medicine you should receive throughout your life. The amount depends on the medical condition being treated and your overall health. Your healthcare professional will watch how much of this medicine you receive. Tell your healthcare professional if you have taken this medicine before.

This medicine can make you more sensitive to the sun. Keep out of the sun, If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• chest pain or palpitations
• feeling faint or lightheaded, falls
• pain, redness, or irritation at site where injected
• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
• signs and symptoms of heart failure like breathing problems, fast, irregular heartbeat, sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in skin or nail color
• diarrhea
• dizziness
• hair loss
• increased skin sensitivity to the sun
• loss of appetite
• mouth sores
• nausea, vomiting
• red urine

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.