Ellence

Ellence is a prescription medication used to treat breast cancer. It is commonly used in combination with other medications. Ellence belongs to a group of drugs called anthracyclines. It works by damaging parts of rapidly multiplying cancer cells, slowing or stopping their growth.

This medication comes in an injectable form to be given through a vein (IV) by a healthcare practitioner in a clinic or hospital. It is typically given once every 21 days for 6 cycles of therapy.

Common side effects include red urine for 1 to 2 days after receiving a dose, nausea, and hot flashes.

Ellence is a prescription medication used to treat breast cancer in patients who have had surgery to remove the tumor.

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

• Pharmacia and Upjohn Company

Common side effects of Ellence may include:

• urine that appears red for 1 to 2 days after receiving a dose (normal, no need for alarm)
• nausea and vomiting
• mild diarrhea
• hot flashes
• temporary hair loss
• unusual tiredness or weakness
• eye or eyelid irritation, soreness, pain, or redness
• decrease in the number of certain white blood cells

This is not a complete list of Ellence side effects. Ask your doctor or pharmacist for more information. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• cancer chemotherapy medications such as daunorubicin (Cerubidine), doxorubicin (Doxil), idarubicin (Idamycin), mitoxantrone (Novantrone), cyclophosphamide (Cytoxan), or trastuzumab (Herceptin)
• calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan)
• certain chemotherapy medications such as docetaxel (Taxotere) or paclitaxel (Abraxane, Onxol)
• cimetidine (Tagamet)

You should avoid "live" vaccines while receiving Ellence therapy.

This is not a complete list of Ellence drug interactions. Ask your doctor or pharmacist for more information.

Ellence is injected into a vein, however, it may leak into surrounding tissue causing severe irritation or damage. If you experience any of the following symptoms, call your doctor immediately: pain, itching, redness, swelling, blisters, or sores at the site of injection.

Ellence may increase your risk of serious or life-threatening heart problems at any time during your treatment or months to years after your treatment has ended. If you experience any of the following symptoms, tell your doctor right away: shortness of breath; difficulty breathing; swelling of the hands, feet, ankles or lower legs; or fast, irregular, or pounding heartbeat.

Ellence 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.

Ellence 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.

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

Other possible serious side effects:

• pain, itching, redness, swelling, blisters, or sores in the area of the injection (signs that the medicine is leaking from the vein into which it was injected);
• congestive heart failure, signs of which include: difficulty breathing, and swelling or rapid weight gain (especially in your face and midsection);
• heart rhythm changes;
• increased risk of developing leukemia (cancer of the white blood cells);
• liver disease, signs of which include: nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, yellowing of the skin or eyes;
• anxiety, sweating, severe shortness of breath, wheezing, gasping for breath;
• chest pain, sudden cough, cough with foamy mucus, rapid breathing, coughing up blood;
• lower back pain, blood in your urine, urinating less than usual or not at all;
• numbness or tingly feeling around your mouth, weak pulse, overactive reflexes, confusion, fainting;
• muscle weakness, tightness, or contraction;
• signs of an infection, including fever, chills, body aches, flu symptoms, cough, sores in your mouth and throat;
• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
• bruising easily

Talk to your doctor about the risks of receiving Ellence.

Do not take this medication if you are allergic to any ingredient in it.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ellence there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Ellence, tell your doctor about all of your medical conditions including if you:

• are allergic to Ellence or any other medicine
• have heart disease including congestive heart failure (CHF)
• have liver or kidney disease
• have neutropenia (lower than normal white blood cell levels)
• have an infection

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ellence falls into category D. Women who are pregnant should not receive Ellence therapy. While there are no studies of Ellence in pregnant women, it causes fetal harm in animals. Tell your doctor if you are pregnant or plan to become pregnant, or if you become pregnant while receiving Ellence.

Ellence can interfere with the normal menstrual cycle (period) in women, and may stop sperm production, or cause DNA damage to sperm in men. Men and women receiving Ellence should use effective birth control methods to avoid pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Ellence is excreted in human breast milk, and because of the potential for serious harm to occur, you and your doctor will need to determine whether you should stop nursing, or if a different medication would be a better choice for you.

Ellence comes as a liquid to be injected intravenously (into a vein) by a healthcare practitioner in a clinic or hospital.

Ellence injections may be given once every 21 days for 6 cycles of therapy or it may be given twice (on days 1 and 8) every 28 days for six cycles of therapy.

It is usually given along with other chemotherapy medications. Medications to prevent nausea, vomiting, or infections may also be given.

The dose of Ellence that your doctor recommends will depend on your height and weight, other medicines you are receiving, and your medical conditions.

The recommended dose of Ellence is 100 to 120 mg/m². Other cancer medications are given in combination with Ellence, and, if you receive the 120 mg/m² dose, you should also receive an antibiotic.

Ellence is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.
 

Keep all laboratory and doctor's appointments.

WARNING: RISK OF TISSUE NECROSIS, CARDIAC TOXICITY, SECONDARY ACUTE MYELOGENOUS LEUKEMIA, AND MYELOSUPPRESSION

1. Severe local tissue necrosis will occur if there is extravasation during administration. Ellence must not be given by the intramuscular or subcutaneous route.
2. Cardiac toxicity, including fatal congestive heart failure (CHF), may occur either during therapy with Ellence or months to years after termination of therapy. The probability of developing clinically evident CHF is estimated as approximately 0.9% at a cumulative dose of 550 mg/m2, 1.6% at 700 mg/m2, and 3.3% at 900 mg/m2. In the adjuvant treatment of breast cancer, the maximum cumulative dose used in clinical trials was 720 mg/m2. The risk of developing CHF increases rapidly with increasing total cumulative doses of Ellence in excess of 900 mg/m2; this cumulative dose should only be exceeded with extreme caution. Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Cardiac toxicity with Ellence may occur at lower cumulative doses whether or not cardiac risk factors are present.
3. Secondary acute myelogenous leukemia (AML) has been reported in patients with breast cancer treated with anthracyclines, including Ellence. The occurrence of refractory secondary leukemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The cumulative risk of developing treatment-related AML or myelodysplastic syndrome (MDS), in 7110 patients with breast cancer who received adjuvant treatment with Ellence-containing regimens, was estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years.
4. Severe myelosuppression may occur.