Epirubicin (Injection)

Brand Name(s)

Ellence, Novaplus Epirubicin Hydrochloride

When This Medicine Should Not Be Used

Warnings While Using This Medicine

• This medicine can cause birth defects if it is used by the mother while she is pregnant or by the father when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease, congestive heart failure, gout, or any type of infection.
• Your doctor may monitor your heart before you start receiving epirubicin and while you are getting treatments with this medicine. Call your doctor right away if you have any chest pain, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, rapid weight gain, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems.
• This medicine can rarely cause leukemia (cancer of the blood). Talk with your doctor if you have concerns about this.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• If epirubicin accidentally leaks out of the vein into which it is injected, it may damage some tissues and may cause scarring. Tell the doctor right away if you notice redness, pain, or swelling at the injection site.
• This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.
• This medicine may turn your urine red for 1 or 2 days after your treatment. This is normal and is nothing to worry about. You may want to protect your clothing from being stained.
• Cancer medicines can cause nausea and/or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Introduction

Epirubicin Hydrochloride (ep-i-ROO-bi-sin hye-droe-KLOR-ide)

Used with other cancer medicines to treat breast cancer.

How to Use This Medicine

Injectable

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• This medicine must be given slowly, so the IV tube must remain in place for at least 15 to 20 minutes. It is usually given every 3 to 4 weeks.
• You may also receive other medicines to help prevent allergic reactions and nausea or vomiting from epirubicin.
• Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using cimetidine (Tagamet®), trastuzumab (Herceptin®), or certain blood pressure medicines (such as diltiazem, nifedipine, verapamil, Cardizem®, Norvasc®, or Verelan®). Tell your doctor if you are also using certain cancer medicines (such as docetaxel, paclitaxel, Taxol®, or Taxotere®) or a radiation treatment.
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast, slow, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Pain, itching, burning, redness, swelling, or a lump under your skin where the needle is placed.
• Painful mouth sores that keep you from drinking liquids.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

• Burning, dry, or itching eyes.
• Changes in menstrual periods.
• Diarrhea, nausea, vomiting, or loss of appetite.
• Hair loss.
• Rash or itching skin.
• Unusual drowsiness, dullness, tiredness, or feeling of sluggishness.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088