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Label Changes for:

Ellence (epirubicin hydrochloride) injection

September 2011

Changes have been made to the WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2011


*Conversion to PLR format, editorial changes


  • sections of the package insert to incorporate information related to cardiotoxicity relative to dosing with other cardiotoxic drugs and risk of infection following vaccination.
Injection-Related Reactions
  • Ellence injection is administered by intravenous infusion. Venous sclerosis may result from an injection into a small vessel or from repeated injections into the same vein. Extravasation…
  • Ellence can suppress bone marrow function as manifested by leukopenia, thrombocytopenia and anemia…
  • Do not administer Ellence in combination with other cardiotoxic agents unless the patient’s cardiac function is closely monitored. Patients receiving Ellence after stopping treatment with other cardiotoxic agents, especially…
Secondary Leukemia
  • The occurrence of secondary acute myelogenous leukemia, with or without a preleukemic phase, has been reported in patients treated with anthracyclines. Secondary leukemia is more common when such drugs are…
Coadministration with Cimetidine
  • Cimetidine increased the AUC of epirubicin by 50%. Stop Cimetidine treatment during treatment with Ellence.
  • Ellence can cause fetal harm when administered to a pregnant woman. Epirubicin was embryolethal and teratogenic in rats and rabbits. There are no adequate and well-controlled studies of Ellence in pregnant women. If this drug is used during pregnancy, or if the patient becomes
    pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Male Fertility and Reproductive Outcomes
  • Males with female sexual partners of childbearing potential should use contraception during and after cessation of fludarabine phosphate therapy. Fludarabine phosphate may damage testicular tissue and spermatozoa. Possible sperm DNA damage raises concerns about loss of fertility and genetic abnormalities in fetuses. The duration of this effect is uncertain.
Laboratory Testing
  • Assess blood counts, including absolute neutrophil counts, and liver function before and during each cycle of therapy with Ellence. Perform repeated evaluations of LVEF during therapy.
Inflammation following Irradiation
  • As with other anthracyclines, administration…


Cardioactive Compounds
  • Do not administer Epirubicin in combination with other cardiotoxic agents unless the patient’s cardiac function is closely monitored. Patients receiving epirubicin after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, may also be at an increased risk of developing cardiotoxicity...
  • Cimetidiene increases the exposure to epirubicin. Stop Cimetidine during treatment with Ellence.

Other Cytotoxic Drugs
  • Ellence used in combination with other cytotoxic drugs may show on-treatment additive toxicity, especially hematologic and gastrointestinal effects.
  • The administration of epirubicin immediately prior to or after paclitaxel increased the systemic exposure of epirubicin, epirubicinol and 7-deoxydoxorubicin aglycone.
  • The administration of epirubicin immediately prior to or after docetaxel did not have an effect on the systemic exposure of epirubicin, but increased the systemic exposure of epirubicinol and 7-deoxydoxorubicin aglycone.
Radiation Therapy
  • There are few data regarding the coadministration of radiation therapy and Ellence. In adjuvant trials of Ellence-containing CEF-120 or FEC-100 chemotherapies, breast irradiation was delayed until after chemotherapy was completed. This practice resulted in no apparent increase in local breast cancer recurrence relative to published accounts in the literature. A small number of patients received Ellence-based chemotherapy concomitantly with radiation therapy but had chemotherapy interrupted in order to avoid potential overlapping toxicities. It is likely that use of Ellence with radiotherapy may sensitize tissues to the cytotoxic actions of irradiation. Administration of Ellence after previous radiation therapy may induce an inflammatory recall reaction at the site of the irradiation.
Concomitant Therapies-Hepatic Function
  • Epirubicin is extensively metabolized by the liver. Changes…