Monograph Details
|
|
Neoplasms
> Cytotoxic antibiotics
|
|
ELLENCE |
| Manufacturer |
|
Pfizer Labs |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Anthracycline. |
| Generic Name |
|
Epirubicin HCl 2mg/mL; soln for IV infusion; preservative-free. |
| Indications |
|
Adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. |
| Children |
|
Not recommended. |
| Adults |
|
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 literature. |
| Contraindications |
|
Baseline neutrophil count <1500 cells/mm3. Severe myocardial insufficiency. Recent MI. Severe arrhythmias. Previous treatment with anthracyclines (max cumulative doses). Severe hepatic dysfunction. |
| Precautions |
|
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. Avoid extravasation. Elderly (esp. female ≥70yrs). Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended. |
| Interactions |
|
Caution with other cardiotoxic drugs. Potentiated by cimetidine. Inflammatory recall reaction possible with previous radiation therapy. |
| Adverse Reactions |
|
Myelosuppression (leukopenia, neutropenia, anemia, thrombocytopenia), GI upset, mucositis, alopecia, lethargy, amenorrhea, infection, conjunctivitis/keratitis, cardiotoxicity, hyperuricemia; acute myelogenous leukemia. |
| How Supplied |
|
Single-use vials (25mL, 100mL)—1 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
