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epirubicin (Rx)Brand and Other Names:Ellence, Pharmorubicin

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL

powder for reconstitution

  • 50 mg
  • 200 mg
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Adjuvant Breast Cancer Treatment

Option 1 (Day 1 dose schedule)

  • Day 1: Epirubicin 100 mg/m² IV, AND 5-fluorouracil 500 mg/m² IV, AND cyclophosphamide 500 mg/m² IV 
  • Repeat q21Days x 6 cycles

Option 2 (Divided dose schedule)

  • First dose divided equally between days 1 & 8: Epirubicin 60 mg/m² IV, AND 5-fluorouracil 500 mg/m² IV, AND
  • Days 1-14: Cyclophosphamide 75 mg/m² PO
  • Repeat q28Days x 6 cycles

Dose Modifications

Adjustment if Total Dose Given on Day 1

  • Administer 75% of Day 1 dose in subsequent cycles if nadir platelet count <50,000/mm³, absolute neutrophil count (ANC) < 250/mm³, neutropenic fever present, grade 3/4 nonhematologic toxicity observed

Divided Dose Adjustment

  • Administer 75% of Day 1 dose on Day 8 if platelet count 75,000-100,000/mm³ and ANC < 1000-1499/mm³
  • Do not administer dose on day 8 if platelet count < 75,000/mm³ and ANC < 1000/mm³

Bone Marrow Dysfunction

  • Consider lower starting dose (75-90 mg/m²)

Renal Impairment

SCr >5 mg/dL [>442 micromoles/L]: Decrease dose by 50%; test cardiac ejection fraction via MUGA before starting treatment

Hepatic Impairment

Billirubin < 1.2 mg/dL: Dose adjustment not necessary

Bilirubin 1.2-3 mg/dL or AST 2-4 x ULN: 50% of recommended starting dose  

Bilirubin >3 mg/dL or AST > 4 x ULN: 25% of recommended starting dose (ie, decrease starting dose by 75%)

Severe hepatic impairment: Not recommended

Monitoring

LFTs, CBC, creatinine; multi-gated radionuclide angiography or ECHO

Safety & efficacy not established

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Interactions

Interaction Checker

epirubicin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Alopecia (96%)

            Nausea and vomiting (92%)

            Leukopenia or neutropenia (80%)

            Amenorrhea (72%)

            Anemia (72%)

            Mucositis (59%)

            Thrombocytopenia (49%)

            Lethargy (46%)

            Hot flashes (39%)

            Diarrhea (25%)

            Conjunctivitis (15%)

            1-10%

            Rash (9%)

            Fever (5%)

            Skin changes (5%)

            Anorexia (3%)

            <1%

            Acute lymphoid leukemia

            Acute myelogenous leukemia

            Atrioventricular block

            Esophagitis

            Hyperpigmentation

            Myelodysplastic syndrome

            Frequency Not Defined

            Myocardial toxicity (including CHF)

            Severe myelosuppression

            Risk of secondary AML

            Postmarketing Reports

            Infections and infestations: Sepsis, pneumonia

            Immune system disorders: Anaphylaxis

            Metabolism and nutrition disorders: Dehydration, hyperuricemia

            Vascular disorders: Shock, hemorrhage, embolism arterial, thrombophlebitis, phlebitis

            Respiratory, thoracic and mediastinal disorders: Pulmonary embolism

            Gastrointestinal disorders: Erosions, ulcerations, pain or burning sensation, bleeding, hyperpigmentation of the oral mucosa

            Skin and subcutaneous tissue disorders: Erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin (radiation-recall reaction), urticaria

            Renal and urinary disorders: Red coloration of urine for 1-2 days after administration

            General disorders and administration site conditions: Fever, chills

            Injury, poisoning and procedural complications: Chemical cystitis (following intravesical administration)

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            Warnings

            Black Box Warnings

            Reduce dosage with impaired hepatic function  

            Severe myelosuppression may occur  

            Administer only under the supervision of physician experienced in the use of cancer chemotherapeutic agents

            Extravasation

            • Severe local tissue necrosis associated with extravasation during administration; administer only by IV route (not IM or SC)

            Cardiotoxicity

            • Myocardial toxicity, manifested in its most severe form by potentially fatal congestive heart failure (CHF); may occur months to years after treatment discontinued
            • Probability of cardiotoxocity estimated to be 0.9% at a cumulative dose of 550 mg/m², 1.6% at 700 mg/m², and 3.3% at 900 mg/m²

            Secondary malignancies

            • Secondary acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS)
            • More common when given in combination with DNA-damaging antineoplastic agents, patients heavily pretreated with cytotoxic drugs, or with escalated anthracycline doses
            • Cumulative risk of developing treatment-related AML or MDS estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years

            Contraindications

            Hypersensitivity

            Baseline ANC<1500/mm³

            Cardiomypathy and/or heart failure, recent MI, or severe arrhythmias

            Cumulative dose achieved in previous anthracycline treatment

            Severe hepatic impairment

            Cautions

            Vesicant

            Increased dose-related risk of seondary leukemia (AML, MDS)

            Risk of cardiomyopathy

            Emetogenic

            Thrombophlebitis may occur

            Women of child-bearing potential should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in breast milk; do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Anthracycline; intercalates between DNA base pairs and triggers cleavage by topoisomerase II, which results in cytocidal activity

            Inhibits DNA helicase and generates cytotoxic free radicals

            Pharmacokinetics

            Half-Life: 31-35 hr

            Protein Bound: 77%

            Vd: 21-27 L/kg

            Metabolism: Hepatic

            Clearance: 65-69 L/hr

            Excretion: Feces (34-35%) & urine (20-27%)

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            Administration

            IV Incompatibilities

            Additive: Alkaline solutions, heparin, fluorouracil

            Syringe: Fluorouracil, ifosfamide with mesna

            IV Compatibilities

            Additive, Syringe: ifosfamide

            IV Administration

            Administer infuse into tubing of a freely flowing infusion (NS or D5W) over 3-5 min

            Avoid extravasation, associated with severe ulceration & soft tissue necrosis; flush with 5-10 mL of IV solution before & after drug administration

            Extravasation Management

            See Totect

            Storage

            Store refrigerated

            Protect from light

            Solution should be used within 24 hr of penetrating rubber stopper

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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