Ellence

Ellence is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Ellence is used to treat breast cancer.

Ellence may also be used for purposes not listed in this medication guide.

Ellence is given as an IV infusion into a vein. A healthcare provider will give you this injection.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Ellence.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Ellence is injected.

If any of this medicine accidentally gets on your skin, wash it thoroughly with soap and warm water.

Epirubicin affects your immune system. You may get infections more easily, even serious or fatal infections. Your blood will need to be tested often. Your heart function may also need to be checked using an electrocardiograph or ECG (sometimes called an EKG). Your cancer treatments may be delayed based on the results of these tests.

You may be given other medications to help prevent infections or certain side effects. Keep using these medicines for as long as your doctor has prescribed.

You should not use Ellence if you have an untreated or uncontrolled infection, severe liver disease, severe heart problems, or if you have recently had a heart attack. You may not be able to use Ellence if you have already been treated with a certain amount of other cancer medications.

Tell your caregivers if you feel any burning, pain, or swelling around the needle when Ellence is injected.

Ellence can cause dangerous effects on your heart that may not be reversible and could occur months to years after you receive Ellence. Call your doctor right away if you have symptoms of heart problems: swelling, rapid weight gain, shortness of breath.

Ellence affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests and your cancer treatments may be delayed.

Before you are treated with Ellence, tell your doctor about all other cancer medications and treatments you have received, including radiation.

You should not use Ellence if you are allergic to epirubicin or similar medications (such as daunorubicin, doxorubicin, idarubicin,mitoxantrone, or valrubicin), or if you have:

• an untreated or uncontrolled infection (including mouth sores);
• severe liver disease;
• severe heart problems; or
• if you have recently had a heart attack.

You may not be able to use Ellence if you have already been treated with a certain amount of other cancer medications.

To make sure Ellence is safe for you, tell your doctor if you have ever had:

• heart problems;
• radiation to your chest area;
• liver or kidney disease;
• bone marrow suppression; or
• chemotherapy with doxorubicin, daunorubicin, epirubicin, idarubicin, or mitoxantrone.

Using Ellence may increase your risk of developing other cancers, such as leukemia. Ask your doctor about this risk.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Epirubicin can harm an unborn baby if the mother or father is using this medicine. Women should keep using birth control for 6 months after the last dose. Men should use birth control for 3 months after the last dose, and should use a condom if their partner is pregnant during treatment and for at least 7 days after the last dose.

Epirubicin may cause you to stop having menstrual periods and may also cause premature menopause. Talk with your doctor if you have concerns about these risks.

You should not breastfeed while using Ellence and for at least 7 days after your last dose.

Get emergency medical help if you have signs of an allergic reaction to Ellence: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Epirubicin can cause dangerous effects on your heart that may not be reversible and could occur months to years after you receive Ellence. Call your doctor right away if you have symptoms of heart problems: swelling, rapid weight gain, shortness of breath.

Also call your doctor at once if you have:

• fast or slow heartbeats;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
• pain, blistering, redness, bruising, or skin changes where the injection was given;
• severe vomiting;
• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
• fluid build-up in or around the lungs - pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold and clammy skin, anxiety, rapid heartbeats;
• signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth; or
• signs of infection - fever, chills, flu symptoms, mouth sores, shallow breathing, pale or blue-colored skin.

Common Ellence side effects may include:

• nausea, vomiting, diarrhea;
• temporary hair loss;
• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• hot flashes, missed menstrual periods;
• discoloration of your skin or nails;
• lack of energy; or
• red-colored urine for 1 or 2 days after each injection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Breast Cancer -- Adjuvant:

Initial dose: 100 to 120 mg/m2 IV in repeated 3- to 4-week cycles; either total dose on Day 1 of each cycle, or divided equally and given on Days 1 and 8 of each cycle CEF-120 regimen (repeat every 28 days for 6 cycles): -Cyclophosphamide: 75 mg/m2 orally on Days 1 to 14 -Epirubicin: 60 mg/m2 IV on Days 1 and 8 -5-Fluorouracil: 500 mg/m2 IV on Days 1 and 8 FEC-100 regimen (repeat every 21 days for 6 cycles): -5-Fluorouracil: 500 mg/m2 IV on Day 1 -Epirubicin: 100 mg/m2 IV on Day 1 -Cyclophosphamide: 500 mg/m2 IV on Day 1 Recommended infusion rates: -For starting doses of 100 to 120 mg/m2, give the infusion over 15 to 20 minutes. -For patients who require lower starting doses due to organ dysfunction or who require modification of doses during therapy, the infusion time may be proportionally decreased, but should not be less than 3 minutes to minimize the risk of thrombosis or perivenous extravasation, which could lead to severe cellulitis, vesication, or tissue necrosis. -A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration. Venous sclerosis may result from injection into small vessels or repeated injections into the same vein. Comments: -Doses are manufacturer suggested. Consult local protocol. -Consider use of antiemetics when given in conjunction with other emetogenic drugs. -Patients administered the 120 mg/m2 regimen should receive prophylactic antibiotics. Use: As adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer

Call your doctor for instructions if you miss an appointment for your Ellence injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Epirubicin can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Do not receive a "live" vaccine while using Ellence. You could develop a serious or fatal infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Tell your doctor about all your other medicines, especially:

• cimetidine (Tagamet);
• other cancer medicines (especially trastuzumab); or
• heart or blood pressure medication.

This list is not complete. Other drugs may interact with epirubicin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.