Generic Name and Formulations:
Epirubicin HCl 2mg/mL; soln for IV infusion; preservative-free.
Indications for ELLENCE:
Adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.
Give by IV infusion over 15–20 minutes. Administer in repeated 3–4 week cycles for a total of 6 cycles. Total dose may be given on Day 1 of each cycle; or divided equally and given on Days 1 and 8 of each cycle. Initially 100–120mg/m2. Bone marrow dysfunction: consider lower starting dose (75–90mg/m2). Renal or hepatic impairment, dose adjustments: see full labeling.
Baseline neutrophil count <1500 cells/mm3. Cardiomyopathy and/or heart failure. Recent MI. Severe arrhythmias. Previous treatment with anthracyclines (max cumulative doses). Severe hepatic dysfunction.
Cardiovascular disease. Prior or concomitant radiotherapy to mediastinal/pericardial area. Previous anthracycline therapy. Renal or hepatic impairment. Monitor CBCs, platelets, cardiac, renal, and hepatic function before and during each treatment cycle. Consider monitoring serum uric acid, potassium, calcium, phosphate after starting therapy. Avoid extravasation. Elderly (esp. female ≥70yrs). Advise women of child-bearing potential to avoid becoming pregnant during treatment and use effective contraceptive methods. Pregnancy (Cat.D). Nursing mothers: not recommended.
Caution with other cardiotoxic drugs. Avoid concomitant live vaccines. Potentiated by cimetidine; stop cimetidine during therapy. Inflammatory recall reaction possible with previous radiation therapy.
Myelosuppression (leukopenia, neutropenia, anemia, thrombocytopenia), amenorrhea, lethargy, nausea, vomiting, mucositis, diarrhea, infection, conjunctivitis/keratitis, alopecia, local toxicity, rash/itch; cardiotoxicity, hyperuricemia, acute myelogenous leukemia.
Single-use vials (25mL, 100mL)—1
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