Epirubicin Hydrochloride

Epirubicin Hydrochloride is used in the treatment of various types of cancers of blood, breast, stomach, lung, ovaries and soft tissues. It also helps to prevent the recurrence of bladder cancer after surgery.

It is given as a drip or infusion vein with extreme caution by a qualified medical professional. It can be used alone, or sometimes given together with certain other medicines as part of combination chemotherapy.

Epirubicin Hydrochloride is an anti-cancer medication. It works by suppressing the activity of an enzyme (topoisomerase II) involved in DNA multiplication of the breast cancer cells. It also forms harmful chemicals (free radicals) which cause DNA damage. This slows the growth of breast cancer cells and eventually kills them.

• 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.

Cytotoxic Chemotherapy

Anthracycline Antitumor Antibiotic

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.

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 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.

Your doctor or nurse will give you this medicine. Kindly do not self administer. Epirubicin Injection should be administered by intravenous infusion.

If you miss a dose of Epirubicin Hydrochloride, please consult your doctor.

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)

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.

Contraindications:

• Cardiac impairment, severe or recent MI
• Previous full cumulative doses of anthracyclines
• Hypersensitivity
• Severe hepatic dysfunction
• Pregnancy, lactation

Drug Interactions:

• Paclitaxel and other anthracyclines: May interact.
• Cimetidine: Increases exposure to Epirubicin; should be stopped during treatment.
• Heparin: May interact.
• Antineoplastic drugs, cardiotoxic drugs, radiation: May show additive toxicity.
• Paclitaxel or Docetaxel: May increase systemic exposure of Epirubicin.
• Radiation Therapy: May induce an inflammatory recall reaction at the site of the irradiation.

Food Interactions: It is unsafe to consume alcohol with Epirubicin Hydrochloride. Avoid alcohol.

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.

Use in Lactation: Epirubicin Hydrochloride is unsafe to use during breastfeeding. Data suggests that the drug may cause toxicity to the baby.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Pediatric patients may be at greater risk for anthracycline-induced cardiotoxicity.

Geriatric Use: Particular care should be taken in monitoring toxicity when administered to female patients ≥70 years of age.

Renal Impairment: Probably safe to use in patients with kidney disease. Limited data suggests dose adjustment may not be needed. Consider lower doses if SCr >5 mg/dL.

Hepatic Impairment: Use with caution in patients with liver disease. Dose adjustment may be needed. Not recommended in patients with severe liver disease.

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.

Epirubicin Hydrochloride