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Epribenz 10/50 Lyophilized Injection

Generic Name – Epirubicin hydrochloride

Drug Class – Antineoplastic agent

Epirubicin is an anthracycline topoisomerase II inhibitor, which is derived from doxorubicin. It is the most active single agent used in the management of patients with breast cancer. It produces its antitumor and cytotoxic effects by inhibiting nucleic acid and protein synthesis.

Product Description

Epribenz 10/50 (Epirubicin for injection) is a lyophilized powder available in single use vial. It provides an effective and stable formulation for enhanced response rates.

Indications and Usage

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

Dosage and Administration

  • Dosage Regimens for Breast Cancer

Recommended dose of Epirubicin is 100 to 120 mg/m2. The following combination regimens are recommended:

Cyclophosphamide, Epirubicin and 5-Flourouracil (CEF) Regimen
Cyclophosphamide 75 mg/m2 PO on days 1-14
Epirubicin 60 mg/m2 IV on days 1, 8
5-Flourouracil 500 mg/m2 IV on days 1, 8
Repeat every 28 days for 6 cycles
OR
5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) Regimen
5-Flourouracil 500 mg/m2 IV on days 1
Epirubicin 100 mg/m2 IV on days 1
Cyclophosphamide 500 mg/m2 IV on days 1
Repeat every 21 days for 6 cycles

Dosage Form and Strength

  • Supplied as a single use vial containing sterile lyophilized powder for intravenous use
  • Available as 10mg and 50mg for injection

Clinical Efficacy

  • Highly effective both for the treatment of patients with metastatic disease and as an adjuvant therapy
  • Produces higher response rates with improved survival outcomes and quality of life in patients with early and advanced breast cancer
  • Ideal for retreating patients who progress or relapse after receiving an anthracycline-/taxane-containing regimen with the same active drugs
  • Shows lower propensity to produce cardio toxic effects, thus allowing for more treatment cycles and higher doses

Adverse reactions

  • The most common adverse events occurring in patients treated with epirubicin are nausea/vomiting, diarrhea, leucopenia, neutropenia, anemia, thrombocytopenia, amenorrhea, lethargy, mucositis, infection, conjunctivitis/keratitis, alopecia, and skin rashes
  • Other serious adverse reactions includes myocardial toxicity, secondary acute myelogenous leukemia, thrombophlebitis and severe local tissue necrosis associated with extravasations during administration

Contraindications

  • It is contraindicated in patients with a known hypersensitivity to epirubicin and other anthracyclines
  • It is not recommended for use in patients with baseline neutrophil count < 1500 cells/mm3, cardiomyopathy and/or heart failure, recent myocardial infarction, severe arrhythmias, previous treatment with anthracyclines up to the maximum cumulative dose or severe hepatic dysfunction

Special Precautions

  • Patients should be carefully monitored for cardio toxicity and severe complications due to myelosuppression during therapy
  • Patients with impaired cardiac function should be carefully evaluated before treatment with epirubicin and it should not be used in combination with other cardio toxic agents
  • Dose should be reduced in patients with hepatic and severe renal impairment
  • Serum uric acid, potassium, calcium, phosphate, and creatinine levels should be monitored immediately after initial chemotherapy to prevent risk of hyperuricemia
  • Dose modifications should be considered based on hematologic and non-hematological toxicities
  • Patients administered with epirubicin as a component of combination chemotherapy should receive prophylactic antibiotic therapy to avoid injection related reactions
  • Prophylactic use of anti-emetics should be considered before using epirubicin, as it can cause nausea and vomiting
  • Use of epirubicin after previous radiotherapy may induce an inflammatory reaction at site of irradiation
  • Stop the use of cimetidine during treatment with epirubicin
  • Avoid administration of live or attenuated vaccines in patients receiving epirubicin as it may result in serious or fatal infections
  • Epirubicin can cause harm to fetus, therefore it is not recommended for use in pregnant and breast feeding mothers
Epirubicin Hydrochloride 50mg Injection | Brand Name EPRIBENZ