Brand and Other Names:Ellence, Pharmorubicin
- Classes: Antineoplastics, Anthracycline
Dosing & Uses
Dosage Forms & Strengths
powder for reconstitution
- 50 mg
- 200 mg
Adjuvant Breast Cancer Treatment
Option 1 (Day 1 dose schedule)
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
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)
SCr >5 mg/dL [>442 micromoles/L]: Decrease dose by 50%; test cardiac ejection fraction via MUGA before starting treatment
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
LFTs, CBC, creatinine; multi-gated radionuclide angiography or ECHO
Safety & efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Nausea and vomiting (92%)
Leukopenia or neutropenia (80%)
Hot flashes (39%)
Skin changes (5%)
Acute lymphoid leukemia
Acute myelogenous leukemia
Frequency Not Defined
Myocardial toxicity (including CHF)
Risk of secondary AML
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)
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
- Severe local tissue necrosis associated with extravasation during administration; administer only by IV route (not IM or SC)
- 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 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
Cardiomypathy and/or heart failure, recent MI, or severe arrhythmias
Cumulative dose achieved in previous anthracycline treatment
Severe hepatic impairment
Increased dose-related risk of seondary leukemia (AML, MDS)
Risk of cardiomyopathy
Thrombophlebitis may occur
Women of child-bearing potential should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods
Pregnancy & Lactation
Pregnancy Category: D
Lactation: not known if excreted in breast milk; do not nurse
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.
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
Half-Life: 31-35 hr
Protein Bound: 77%
Vd: 21-27 L/kg
Clearance: 65-69 L/hr
Excretion: Feces (34-35%) & urine (20-27%)
Additive: Alkaline solutions, heparin, fluorouracil
Syringe: Fluorouracil, ifosfamide with mesna
Additive, Syringe: ifosfamide
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
Protect from light
Solution should be used within 24 hr of penetrating rubber stopper
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