Recommended Topic Related To:

Ellence

"The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.

HER2 is a protein involved in normal cell growth. It is foun"...

Ellence

ELLENCE®
(epirubicin hydrochloride) Injection

Ellence

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 [see WARNINGS AND PRECAUTIONS].
  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 [see WARNINGS AND PRECAUTIONS].
  3. Secondary acute myelogenous leukemia (AML) has been reported in patients with breast cancer treated with anthracyclines, including epirubicin. 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 [see WARNINGS AND PRECAUTIONS].
  4. Severe myelosuppression may occur [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

ELLENCE Injection (epirubicin hydrochloride injection) is an anthracycline cytotoxic agent, intended for intravenous administration. ELLENCE is supplied as a sterile, clear, red solution and is available in polypropylene vials containing 50 and 200 mg of epirubicin hydrochloride as a preservative-free, ready-to-use solution. Each milliliter of solution contains 2 mg of epirubicin hydrochloride. Inactive ingredients include sodium chloride, USP, and water for injection, USP. The pH of the solution has been adjusted to 3.0 with hydrochloric acid, NF. Epirubicin hydrochloride is the 4-epimer of doxorubicin and is a semi-synthetic derivative of daunorubicin. The chemical name is (8S-cis)-10[(3-amino-2,3,6-trideoxy-α-L- arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-naphthacenedione hydrochloride. The active ingredient is a red-orange hygroscopic powder, with the empirical formula C27H29NO11 HCl and a molecular weight of 579.95. The structural formula is as follows:

ELLENCE® (epirubicin hydrochloride)  Structural Formula Illustration

What are the possible side effects of epirubicin (Ellence)?

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

Call your doctor at once if you have a serious side effect such as:

  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • severe burning, stinging, pain, swelling, redness, or skin changes around the IV needle;
  • white patches or sores inside your mouth or on your lips;
  • severe vomiting, thirst, and hot dry skin;
  • fever, chills, body aches, flu...

Read All Potential Side Effects and See Pictures of Ellence »

What are the precautions when taking epirubicin hydrochloride (Ellence)?

Before using epirubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or to anthracenediones (e.g., 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 (e.g., anemia, low blood cell counts), gout, heart disease (e.g., congestive heart failure, recent heart attack, fast/slow/irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area).

Do not have immunizations/vaccinations without the consent of your doctor, and...

Read All Potential Precautions of Ellence »

Last reviewed on RxList: 3/7/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Breast Cancer

Find support and advances in treatment.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations