Erubin 50

• Cancer: Indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. Used for lymphoma, multiple myeloma, solid tumors, acute leukemias.

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.

Adult Dose:

• Adjuvant Breast Cancer (FEC-100): 5-Fluorouracil 500 mg/m² + Epirubicin 100 mg/m² + Cyclophosphamide 500 mg/m² IV Day 1, q21Days x 6 cycles.
• CEF-120: Cyclophosphamide 75 mg/m² PO D 1-14 + Epirubicin 60 mg/m² IV D 1,8 + 5-Fluorouracil 500 mg/m² IV D 1,8; q28Days x 6 cycles.
• Single Agent: 60-90 mg/m² every 3-4 weeks; Max total cumulative dose: 0.9-1 g/m².
• Palliative Care: 12.5-25 mg/m² once weekly.

Hepatic Impairment: Bilirubin 3 mg/dL or AST > 4 x ULN: 25% of recommended starting dose; Severe hepatic impairment: Not recommended.

Renal Dose: SCr >5 mg/dL: Decrease dose by 50%; test cardiac ejection fraction via MUGA before starting treatment.

Common Side Effects:

• Myelosuppression
• Cardiotoxicity
• Alopecia (hair loss)
• Hyperpyrexia
• Lethargy
• Amenorrhea (menstrual cessation)
• Nausea
• Vomiting
• Diarrhea
• Fever
• Rash
• Anorexia
• Reddish appearance of urine (1-2 days)

Use in Pregnancy: Category D. There are no adequate and well-controlled studies in pregnant women. Should be used only if the potential benefit justifies the potential risk to the fetus.

Precautions:

• Epirubicin Hydrochloride may cause side effects which could affect your ability to drive.
• It may make you feel tired or sleepy. Do not drive or do anything requiring mental focus until you know how it affects you.
• Use a reliable contraceptive method during treatment and for 6 months after stopping treatment.
• Your doctor may get regular blood tests done to monitor your blood cells, liver, and heart function during treatment.
• Inform your doctor immediately if you notice any signs of infection such as fever, sore throat or rash.
• Procedures for proper handling and disposal of anticancer drugs should be used when handling and preparing Epirubicin.
• Should be administered only under the supervision of qualified physicians experienced in the use of cytotoxic therapy.

Overdose: Supportive treatment should be provided (including antibiotic therapy, blood and platelet transfusions, colony-stimulating factors, and intensive care) until recovery of toxicities. Delayed CHF has been observed months after anthracycline administration.

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