Epirubicin Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.

Cytotoxic Chemotherapy

Epirubicin, an anthracycline with cytotoxic properties. It inhibits DNA and RNA synthesis by steric obstruction after intercalating between DNA base pairs that triggers DNA cleavage by by topoisomerase II. It also inhibits DNA helicase and generates cytotoxic free radicals.

Acute leukaemias; Lymphoma; Multiple myeloma; Solid tumours: As a single agent: 60-90 mg/m2 3-4 wkly. Max (total cumulative dose): 0.9-1 g/m2. Palliative care: 12.5-25 mg/m2 once wkly. Adjuvant treatment in axillary-node positive breast cancer: Recommended starting doses: 100-120 mg/m2 as a single dose on day 1 or as 2 divided doses on days 1 and 8 of each 28-day cycle. Repeat for 6 cycles.Intravesical Local treatment of bladder carcinoma: As 0.1% soln: 50 mg/wk for 8 wk; reduce dose if chemical cystitis develops.For carcinoma in-situ: 80 mg in 50 mL wkly. For prevention of recurrence in patients who have undergone transurethral resection: 50 mg/wk for 4 wk, followed by 50 mg/mth for 11 mth; retain soln in the bladder for 1 hr during each administration.

Cardioactive Compounds: Concomitant use of Epirubicin with other cardioactive compounds that could cause heart failure (e.g., calcium channel blockers), requires close monitoring of cardiac function throughout treatment.Cimetidine: Cimetidine increases the exposure to Epirubicin. Cimetidine should be stopped during treatment with Epirubicin.Other Cytotoxic Drugs: Epirubicin used in combination with other cytotoxic drugs may show on treatment additive toxicity, especially hematologic and gastrointestinal effects.Paclitaxel: The administration of Epirubicin immediately prior to or after Paclitaxel increased the systemic exposure of Epirubicin, Epirubicinol and 7-deoxydoxorubicin aglycone.Docetaxel: 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: Administration of Epirubicin after previous radiation therapy may induce an inflammatory recall reaction at the site of the irradiation.Hepatic Function: Epirubicin is extensively metabolized by the liver. Changes in hepatic function induced by concomitant therapies may affect Epirubicin metabolism, pharmacokinetics, therapeutic efficacy, and/or toxicity.

It is contraindicated in patients with known hypersensitivity to Epirubicin or other anthracyclines or anthracenediones or any other components of this product.

Most commonly reported adverse effects are- Myelosuppression, cardiotoxicity, alopecia, hyperpyrexia, lethargy, amenorrhoea, nausea, vomiting, diarrhea, fever, rash, anorexia, harmless reddish appearance of urine for 1-2days.

Discontinue nursing prior to taking Epirubicin. Not known if excreted in breast milk

Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours of equilibration at controlled room temperature (15°-25°C). Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Procedures for proper handling and disposal of anticancer drugs should be used when handling and preparing Epirubicin.Epirubicin Injection should be administered only under the supervision of qualified physicians experienced in the use of cytotoxic therapy. Before beginning treatment with Epirubicin, patients should be recovered from acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) of prior cytotoxic treatment. Also, initial treatment with Epirubicin should be preceded by a careful baseline assessment of blood counts; serum levels of total bilirubin, AST, and creatinine; and cardiac function as measured by left ventricular ejection function (LVEF). Patients should be monitored carefully during treatment for possible clinical complications due to myelosuppression. Supportive care may be necessary for the treatment of severe neutropenia and severe infectious complications. Monitoring for potential cardiotoxicity is also important, especially with greater cumulative exposure to Epirubicin.

If an overdose occurs, supportive treatment should be provided (including antibiotic therapy, blood and platelet transfusions, colony-stimulating factors, and intensive care as needed) until the recovery of toxicities. Delayed CHF has been observed months after anthracycline administration. Patients should be observed carefully over time for signs of CHF and provided with appropriate supportive therapy.

Store in refrigerator or at 2-8°C. Do not freeze. Protect from light and keep out of the reach of children.

Cytotoxic Chemotherapy

Epirubicin Hydrochloride, an anthracycline with cytotoxic properties. It inhibits DNA and RNA synthesis by steric obstruction after intercalating between DNA base pairs that triggers DNA cleavage by topoisomerase II. It also inhibits DNA helicase and generates cytotoxic free radicals.Distribution: Following IV administration, Epirubicin is rapidly and widely distributed into the tissues. Binding of Epirubicin to plasma proteins, predominantly albumin, is about 77% and is not affected by drug concentration.Metabolism: Epirubicin is extensively and rapidly metabolized by the liver and is also metabolized by other organs and cells, including red blood cells.Excretion: Epirubicin and its major metabolites are eliminated through biliary excretion and, to a lesser extent, by urinary excretion. Terminal elimination half-life is 30-40 hrs.

Pregnancy Category D. There are no adequate and well-controlled studies in pregnant women. It should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions from Epirubicin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.