Active Ingredient: Epirubicin
When administered intravesically, epirubicin has been shown to be beneficial in the treatment of:
For this indication, competent medicine agencies globally authorize below treatments:
50 - 80 mg per m² of body surface area (BSA)
From 50 To 80 mg per m² of body surface area (BSA) once every 30 day(s)
Epirubicin can be given by intravesical administration for the treatment of superficial bladder cancer and carcinoma-in-situ. It should not be given intravesically for the treatment of invasive tumours that have penetrated the bladder wall, systemic therapy or surgery is more appropriate in these situations. Epirubicin has also been successfully used intravesically as a prophylactic agent after transurethral resection of superficial tumours to prevent recurrence.
For the treatment of superficial bladder cancer the following regimen is recommended, using the dilution table below:
8 weekly instillations of 50 mg/50 ml (diluted with saline or distilled sterile water).
If local toxicity is observed: A dose reduction to 30 mg/50 ml is advised.
Carcinoma-in-situ: Up to 80 mg/50 ml (depending on individual tolerability of the patient)
For prophylaxis: 4 weekly administrations of 50 mg/50 ml followed by 11 monthly instillations at the same dose.
Dilution table for bledder instillation solutions:
|Dose Epirubicin required||Volume of 2 mg/ml epirubicin hydrochloride injection||Volume of diluent sterile water for injection or 0.9% sterile saline||Total volume for bladder installation|
|30 mg||15 ml||35 ml||50 ml|
|50 mg||25 ml||25 ml||50 ml|
|80 mg||40 ml||10 ml||50 ml|
The solution should be retained intravesically for 1-2 hour. To avoid undue dilution with urine, the patient should be instructed not to drink any fluid in the 12 hours prior to instillation. During the instillation, the patient should be rotated occasionally and should be instructed to void urine at the end of the instillation time.
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