Epirubicin hydrochloride

Epirubicin hydrochloride
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Black Box Warning

WARNING: RISK OF TISSUE NECROSIS, CARDIAC TOXICITY, SECONDARY ACUTE MYELOGENOUS LEUKEMIA, AND MYELOSUPPRESSION See full prescribing information for complete Boxed Warning. * Severe local tissue necrosis will occur if there is extravasation during administration. ELLENCE must not be given by the intramuscular or subcutaneous route. Cardiac toxicity, including fatal congestive heart failure (CHF), may occur either during therapy with ELLENCE or months to years after termination of therapy. The probability of developing clinically evident CHF is estimated as approximately 0.9% at a cumulative dose of 550 mg/m2, 1.6% at 700 mg/m2, and 3.3% at 900 mg/m2. In the adjuvant treatment of breast cancer, the maximum cumulative dose used in clinical trials was 720 mg/m2. The risk of developing CHF increases rapidly with increasing total cumulative doses of ELLENCE in excess of 900 mg/m2; this cumulative dose should only be exceeded with extreme caution. Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Cardiac toxicity with ELLENCE may occur at lower cumulative doses whether or not cardiac risk factors are present. Secondary acute myelogenous leukemia (AML) has been reported in patients with breast cancer treated with anthracyclines, including epirubicin. The occurrence of refractory secondary leukemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The cumulative risk of developing treatment-related AML or myelodysplastic syndrome (MDS), in 7110 patients with breast cancer who received adjuvant treatment with ELLENCE-containing regimens, was estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years. Severe myelosuppression may occur

Overview

Epirubicin hydrochloride is an anthracycline topoisomerase II inhibitor that is FDA approved for the treatment of primary breast cancer with evidence of axillary node tumor involvement. There is a Black Box Warning for this drug as shown here. Common adverse reactions include leukopenia, neutropenia, anemia, thrombocytopenia, amenhorrhea, lethargy, nausea/vomiting, mucositis, diarrhea, infection, conjunctivitis/keratitis, alopecia, local toxicity and rash/itch.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

• Dosage: 100 to 120 mg/m2 for 3 to 4 week cycles

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Epirubicin hydrochloride in adult patients.

Non–Guideline-Supported Use

• Carcinoma of bladder
• Carcinoma of esophagus
• Gastric cancer
• Hodgkin's disease
• Malignant tumor of nasopharynx
• Metastatic breast cancer
• Non-Hodgkin's lymphoma
• Non-small cell lung cancer
• Ovarian cancer
• Small cell carcinoma of lung
• Soft tissue sarcoma

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and efficacy have not been established in pediatric patients

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Epirubicin hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Epirubicin hydrochloride in pediatric patients.

Contraindications

Patients should not be treated with ELLENCE Injection if they have any of the following conditions:

• Cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias.
• Previous treatment with maximum cumulative dose of anthracyclines.
• Hypersensitivity to ELLENCE, other anthracyclines, or anthracenediones

Warnings

WARNING: RISK OF TISSUE NECROSIS, CARDIAC TOXICITY, SECONDARY ACUTE MYELOGENOUS LEUKEMIA, AND MYELOSUPPRESSION See full prescribing information for complete Boxed Warning. * Severe local tissue necrosis will occur if there is extravasation during administration. ELLENCE must not be given by the intramuscular or subcutaneous route. Cardiac toxicity, including fatal congestive heart failure (CHF), may occur either during therapy with ELLENCE or months to years after termination of therapy. The probability of developing clinically evident CHF is estimated as approximately 0.9% at a cumulative dose of 550 mg/m2, 1.6% at 700 mg/m2, and 3.3% at 900 mg/m2. In the adjuvant treatment of breast cancer, the maximum cumulative dose used in clinical trials was 720 mg/m2. The risk of developing CHF increases rapidly with increasing total cumulative doses of ELLENCE in excess of 900 mg/m2; this cumulative dose should only be exceeded with extreme caution. Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Cardiac toxicity with ELLENCE may occur at lower cumulative doses whether or not cardiac risk factors are present. Secondary acute myelogenous leukemia (AML) has been reported in patients with breast cancer treated with anthracyclines, including epirubicin. The occurrence of refractory secondary leukemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The cumulative risk of developing treatment-related AML or myelodysplastic syndrome (MDS), in 7110 patients with breast cancer who received adjuvant treatment with ELLENCE-containing regimens, was estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years. Severe myelosuppression may occur

There is limited information regarding Epirubicin hydrochloride Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Epirubicin hydrochloride Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Epirubicin hydrochloride Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Epirubicin hydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Epirubicin hydrochloride in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Epirubicin hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Epirubicin hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Epirubicin hydrochloride in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Epirubicin hydrochloride in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Epirubicin hydrochloride in geriatric settings.

Gender

There is no FDA guidance on the use of Epirubicin hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Epirubicin hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Epirubicin hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Epirubicin hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Epirubicin hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Epirubicin hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Epirubicin hydrochloride Administration in the drug label.

Monitoring

There is limited information regarding Epirubicin hydrochloride Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Epirubicin hydrochloride and IV administrations.

Overdosage

There is limited information regarding Epirubicin hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Epirubicin hydrochloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Epirubicin hydrochloride Mechanism of Action in the drug label.

Structure

There is limited information regarding Epirubicin hydrochloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Epirubicin hydrochloride Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Epirubicin hydrochloride Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Epirubicin hydrochloride Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Epirubicin hydrochloride Clinical Studies in the drug label.

How Supplied

There is limited information regarding Epirubicin hydrochloride How Supplied in the drug label.

Storage

There is limited information regarding Epirubicin hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Epirubicin hydrochloride Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Epirubicin hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Epirubicin hydrochloride Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Epirubicin hydrochloride Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.