epirubicin 200 mg/100 mL intravenous solution

Generic name:
Epirubicin - injection

Pronunciation
(epp-ih-REWB-ih-sin)

Brand name(s)
Ellence

Epirubicin must be given only by injection slowly into a vein. Do not inject into a muscle or under the skin. If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Tell your doctor right away if you notice redness, pain, or swelling at or near the injection site.

This medication may rarely cause serious (rarely fatal) heart problems (including heart failure). This may occur both during treatment or months to years after treatment is completed. The risk of heart problems is affected by your dose, medical history (including previous heart disease, radiation treatment to the chest area), and previous use of this and other drugs (including doxorubicin). Tell your doctor right away if you notice symptoms such as fast/slow/irregular heartbeat, shortness of breath, swelling ankles/feet, unusual tiredness, or unusual/sudden weight gain.

Epirubicin may cause certain severe blood and bone marrow disorders (low or abnormal red blood cells/white blood cells/platelets). This can affect your body's ability to stop bleeding or fight infection. Tell your doctor right away if you develop unusual tiredness, easy bleeding/bruising, or signs of infection (such as sore throat that doesn't go away, fever, chills).

Very rarely, people with cancer who are treated with this type of medication have developed other cancers (such as secondary leukemia). The risk may be increased when this medication is given with certain anti-cancer drugs (especially in high doses) or radiation treatment. Consult your doctor for more details.

Epirubicin is used to treat breast cancer. It belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for other cancers (such as bone cancer).

This medication is given by injection into a vein by a health care professional, as directed by your doctor. The dosage is based on your medical condition, body size, and response to treatment.

If this medication touches your skin, immediately wash the area well with plenty of water. You may also use soap and water or a mixture of baking soda (sodium bicarbonate) in plenty of water. If this medication gets in your eye, open the eyelids and flush with water for 15 minutes, then get medical help right away.

Drink plenty of fluids while using this medication unless otherwise directed by your doctor. Doing so helps decrease the risk of certain side effects (such as increased uric acid).

See also Warning section.

Nausea, vomiting, diarrhea, abdominal pain, flushing, or skin/nail color changes may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects last or get worse, tell your doctor or pharmacist promptly.

This medication may cause your urine to turn a reddish color. This is a normal, harmless effect of the drug that usually stops within 2 days after each dose and should not be mistaken for blood in your urine.

Temporary hair loss is a common side effect. Normal hair growth should return after treatment has ended.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• menstrual changes (such as stopped periods)
• unusual bleeding/bruising (such as small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds)

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Severe nausea, vomiting, and diarrhea may rarely cause dehydration. Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin.

Epirubicin sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:

• low back/side pain (flank pain)
• signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine)
• muscle spasms/weakness

Get medical help right away if you have any very serious side effects, including:

• chest pain
• coughing up blood
• sudden pain/swelling/redness usually in the leg

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• trouble breathing
• severe dizziness

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using epirubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (such as doxorubicin); or to anthracenediones (such as mitoxantrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood/bleeding disorders (such as anemia, low blood cell counts)
• gout
• heart disease (such as heart failure, recent heart attack, fast/slow/irregular heartbeat)
• kidney disease
• liver disease
• radiation treatment (especially to chest area)

Epirubicin can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using epirubicin before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug.

Children may be more sensitive to the side effects of this drug, especially effects on the heart.

This medication can affect menstruation in females and cause premature menopause. Consult your doctor or pharmacist for details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using epirubicin. Epirubicin may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. Men with pregnant partners should use condoms during treatment and for at least 7 days after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for at least 7 days after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• cimetidine
• other drugs that may affect the heart (including trastuzumab, anthracyclines such as doxorubicin)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, liver/heart function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.