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Ellence Generic Name & Formulations
Legal Class
Rx
General Description
Epirubicin HCl 2mg/mL; soln for IV inj; preservative-free.
Pharmacological Class
Anthracycline.
How Supplied
Single-dose vials (25mL, 100mL)—1
Manufacturer
Generic Availability
NO
Ellence Indications
Indications
Adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.
Ellence Dosage and Administration
Adult
Consider antiemetics before initiation. Give by IV bolus inj (into tubing of freely flowing IV infusion) over 15–20mins (may be less time for lower initial doses, but not <3mins). 100–120mg/m2 (total dose may be given on Day 1 of each cycle, or two equally divided doses given on Days 1 and 8 of each cycle). Administer in repeated 3–4 week cycles for a total of 6 cycles. Bone marrow dysfunction: consider lower starting dose (75–90mg/m2); see full labeling. 120mg/m2 regimen: give prophylactic antibiotics. Renal or hepatic impairment, dose modifications: see full labeling.
Children
Not established.
Ellence Contraindications
Contraindications
Severe myocardial insufficiency. Recent MI. Severe arrhythmias. Previous treatment with anthracyclines (max cumulative doses). Severe persistent drug-induced myelosuppression. Severe hepatic impairment.
Ellence Boxed Warnings
Boxed Warning
Cardiac toxicity. Secondary malignancies. Extravasation and tissue necrosis. Severe myelosuppression.
Ellence Warnings/Precautions
Warnings/Precautions
Risk of cardiac toxicity. Avoid cumulative doses of 900mg/m2. History of cardiovascular disease. Prior or concomitant radiotherapy to mediastinal/pericardial area. Previous anthracycline or anthracenedione therapy. Perform ECG, LVEF before initiation and during treatment; consider discontinuation if LVEF decreases and/or CHF develops. Increased risk of secondary malignancies (eg, AML, MDS). Avoid extravasation. Obtain CBCs, AST, total bilirubin, SCr prior to and during each treatment. Delay next dose if severe myelosuppression has not improved. Monitor blood uric acid, potassium, calcium, phosphate after starting therapy. Hepatic or severe renal impairment: reduce dose. Dialysis. Elderly (esp. females): monitor. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation; (avoid during 1st trimester). Monitor fetus and/or neonate in 2nd and/or 3rd trimesters. Advise use of effective contraception during and for 6mos (females of reproductive potential) or 3mos (males w. female partners) after last dose. Advise males (w. pregnant partners) to use condoms during and for ≥7 days after last dose. Nursing mothers: not recommended (during and for ≥7 days after last dose).
Ellence Pharmacokinetics
See Literature
Ellence Interactions
Interactions
Avoid concomitant cardiotoxic drugs; delay Ellence until other agents have cleared from circulation (eg, up to 7mos after stopping trastuzumab). Concomitant other cardioactive agents (eg, CCBs): monitor cardiac function closely. Avoid concomitant live vaccines. Potentiated by cimetidine; discontinue during Ellence therapy. Additive toxicity (esp. hematologic, GI effects) with other cytotoxic drugs. Incompatible in solutions with alkaline pH, heparin, fluorouracil. Inflammatory recall reaction possible with previous radiation therapy.
Ellence Adverse Reactions
Adverse Reactions
Leukopenia, neutropenia, anemia, thrombocytopenia, amenorrhea, lethargy, nausea, vomiting, mucositis, diarrhea, infection, conjunctivitis/keratitis, alopecia, local toxicity, rash/itch; cardiac toxicity, secondary malignancies, tissue necrosis, tumor lysis syndrome, thrombophlebitis, thromboembolism, potential radiation toxicity/recall.
Ellence Clinical Trials
See Literature
Ellence Note
Not Applicable
Ellence Patient Counseling
See Literature
