Composition
Inj: Per ml: Epirubicin HCI 2 mg; 5 ml (10 mg), 25 ml (50 mg).
Indications & Dosage
Treatment and prophylaxis of certain forms of superficial bladder cancer: BY IV INF: Adults: IV: 100-120 mg/m2 once weekly every 3-4 wk or 50-60 mg/m, days 1 and 8 every 3-4 week. Treatment of breast cancer: Adult: CEF-120: 60 mg/m2 on days 1 and 8 for 8 cycles. FEC-100: 100 mg/m2 on day 1 every 21 days 6 cycles.
Administration
Epirubicin should be administered into the tubing of a freely flowing IV infusion (0.9% NaCI or 5% glu-cose solution). The infusion time ranges between 3-20 min, depending on dosage and volume of the infusion solution. Avoid direct push injection. Flush well with a heparin-free solution before and after epirubicin administration.
Compatibility
Stable in D5W, LR, NS; Incompatible with any solution of alkaline pH incompatible with heparin, fluorouracil.
Stability
Store vials of injection solution in a refrigerator at 2C-8C (36F-46F). Do not freeze. Store vials of powder for solution at 25C (77F); excursions are permitted to 15C-30C (59F-86F). Protect from light. Discard unused portion. Store upright. Reconstituted solutions are stable for 24 hours when stored at 2C-8C (36F-46F) and protected from light, or 25C (77F) in normal lighting conditions. Epirubicin solution is preservative-free and should be used within 24 hours of the first penetration of the rubber stopper.
Contraindications
When used as a bladder instillation: Catheterisation difficulties, haematuria, invasive tumours penetrating the bladder and urinary tract infections. Myocardiopathy, previous treatment with maximum cumulative doses of epirubicin or other anthracycline, recent myocardialinfarction, severe arrhythmia, severe myocardial insufficiency, unstable angina, severe hepatic impairment
Precautions
Caution is necessary with concomitant use of cardiotoxicdrugs, or drugs that reduce cardiac contractility. Monitor blood counts, cardiac function and uric acid levels. Evaluate liver function prior to and during therapy. Redude dose in hepatic and renal impairment
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding.
Side Effects
Alopecia, bone-marrow suppression, Cardiotoxicity, extravasation, hyperpigmentation of nails, oral mucosa and skin, hyperuricaemia, nausea, oral mucositis, redcolouration of the urine, thromboembolism, tumourlysis syndrome, vomiting, hyperpyrexia, myelosuppression