Papillary transitional cell carcinoma of the bladder, carcinoma-in-situ of the bladder

Active Ingredient: Epirubicin

Indication for Epirubicin

Population group: only adults (18 years old or older)

When administered intravesically, epirubicin has been shown to be beneficial in the treatment of:

  • Papillary transitional cell carcinoma of the bladder
  • Carcinoma-in-situ of the bladder.
  • Prophylaxis of recurrences of superficial bladder carcinoma following transurethral resection

For this indication, competent medicine agencies globally authorize below treatments:

50-80 mg once monthly

Route of admnistration


Defined daily dose

50 - 80 mg per m² of body surface area (BSA)

Dosage regimen

From 50 To 80 mg per m² of body surface area (BSA) once every 30 day(s)

Detailed description

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 requiredVolume of 2 mg/ml epirubicin hydrochloride injectionVolume of diluent sterile water for injection or 0.9% sterile salineTotal volume for bladder installation
30 mg15 ml35 ml50 ml
50 mg25 ml25 ml50 ml
80 mg40 ml10 ml50 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.

Active ingredient


Epirubicin is a cytotoxic active antibiotic from the anthracycline group. The mechanism of action of epirubicin is related to its ability to bind to DNA. Cell culture studies have shown rapid cell penetration, localisation in the nucleus and inhibition of nucleic acid synthesis and mitosis.

Read more about Epirubicin

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