Epirubicin hydrochloride

What is Epirubicin hydrochloride?

• Epirubicin hydrochloride (Ellence) is an anthracycline topoisomerase inhibitor used in combination with other medications to treat breast cancer in patients who have had surgery to remove the tumor.

Epirubicin structure

Epirubicin ball-and-stick

What are the uses of this medicine?

• Epirubicin hydrochloride (Ellence) used with other drugs to treat Breast cancer.
• It is used after surgery in patients whose cancer has spread to the lymph nodes under the arm.

How does this medicine work?

• Epirubicin is an anthracycline cytotoxic agent.
• Epirubicin forms a complex with DNA by intercalation of its planar rings between nucleotide base pairs, with consequent inhibition of nucleic acid (DNA and RNA) and protein synthesis.
• Such intercalation triggers DNA cleavage by topoisomerase II, resulting in cytocidal activity.
• Epirubicin also inhibits DNA helicase activity, preventing the enzymatic separation of double-stranded DNA and interfering with replication and transcription.
• Epirubicin is also involved in oxidation/reduction reactions by generating cytotoxic free radicals.
• The antiproliferative and cytotoxic activity of epirubicin is thought to result from these or other possible mechanisms.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Severe myocardial insufficiency
• Recent myocardial infarction or severe arrhythmias
• Severe persistent drug-induced myelosuppression
• Severe hepatic impairment
• Severe hypersensitivity to Ellence, other anthracyclines, or anthracenediones

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan); certain chemotherapy medications such as docetaxel (Taxotere) or paclitaxel (Abraxane, Onxol); or cimetidine (Tagamet).

Is this medicine FDA approved?

• Initial U.S. Approval: 1999

How should this medicine be used?

• Consider use of antiemetics when given in conjunction with other emetigenic drugs.
• Patients administered the 120 mg/m2 regimen of Ellence should receive prophylactic antibiotic therapy.

Recommended dosage:

• The recommended starting dose of Ellence is 100 to 120 mg/m2. Dosage reductions are possible when given in certain combinations.
• Reduce dose in patients with hepatic impairment.
• Consider lower doses in patients with severe renal impairment.
• Adjust dosage after the first treatment cycle based on hematologic and nonhematologic toxicities.

Administration:

• Administer intravenously in repeated 3- to 4-week cycles, either total dose on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 50 mg/25 mL (2 mg/mL), 200 mg/100 mL (2 mg/mL) solution in single-dose vials

This medicine is available in fallowing brand namesː

• Ellence

What side effects can this medication cause?

The most common side effects of this medicine include:

• leukopenia
• neutropenia
• anemia
• thrombocytopenia
• amenorrhea
• lethargy
• nausea/vomiting
• mucositis
• diarrhea
• infection
• conjunctivitis/keratitis
• alopecia
• local skin toxicity
• rash/itch

What special precautions should I follow?

• Ellence and other anthracycline drugs can result in either early (or acute) or late (delayed) cardiac toxicity. Perform a baseline ECG and evaluation of LVEF prior to initiating treatment with Ellence.
• The risk of developing secondary acute myelogenous leukemia and myelodysplastic syndrome (MDS), is increased following treatment with Ellence and other anthracyclines.
• Ellence can cause severe myelosuppression. Obtain complete blood counts prior to each treatment and carefully monitor patients during treatment for possible clinical complications due to myelosuppression.
• Monitor serum total bilirubin and AST levels before and during treatment with Ellence. In patients with elevated serum AST or serum total bilirubin, dosage reductions or discontinuation may be required.
• Ellence can induce tumor lysis syndrome in patients with rapidly growing tumors. Evaluate blood uric acid levels, potassium, calcium, phosphate, and creatinine after initial treatment. Consider hydration, urine alkalinization, and prophylaxis with allopurinol to minimize potential complications of hyperuricemia and tumor lysis syndrome.
• Thrombophlebitis and thromboembolic events, including pulmonary embolism (in some cases fatal) have been reported with the use of Ellence. Venous sclerosis may result from an injection into a small vessel or from repeated injections into the same vein.
• Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including Ellence, may result in serious or fatal infections.
• Administration of Ellence after previous radiation therapy may induce an inflammatory recall reaction at the site of the irradiation.
• Ellence can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• bone marrow aplasia
• mucositis
• gastrointestinal bleeding
• hyperthermia
• multiple organ failure
• lactic acidosis
• increased lactate dehydrogenase
• anuria

Management of overdosage:

• If an overdose occurs, provide supportive treatment (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.
• Observe patients carefully over time for signs of CHF and provided with appropriate supportive therapy.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action, Ellence can cause fetal harm when administered to a pregnant woman; avoid the use of Ellence during the 1st trimester.

Can this medicine be used in children?

• Safety and effectiveness of Ellence have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• EPIRUBICIN HYDROCHLORIDE

Inactive ingredients include:

• SODIUM CHLORIDE
• WATER
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

• It is marketed by Pfizer under the trade name Ellence in the US and Pharmorubicin or Epirubicin Ebewe elsewhere.

What should I know about storage and disposal of this medication?

• Store refrigerated between 2°C and 8°C (36°F and 46°F).
• Do not freeze.
• Protect from light.
• Solution for injection should be used within 24 hours after removal from refrigeration.
• Ellence is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Epirubicin hydrochloride
• FDA Epirubicin hydrochloride

Epirubicin hydrochloride Resources
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