Epirubicin HCl 50 mg/25 ml

18 Years Old and Above

Intravenous (IV) administration
Dosage is usually calculated on the basis of body surface area (mg/m²). The total epirubicin dose per cycle to be delivered may differ according to its use within a specific treatment regimen (e.g. given as a single agent or in combination with other cytotoxic drugs) and according to the therapeutic indication (e.g. in the treatment of breast and lung cancer epirubicin is also used at dose higher than conventional).

Intravenous administration of epirubicin should be performed with caution. It is recommended to administer epirubicin into the tubing of a freely flowing IV infusion (0.9% sodium chloride or 5% glucose solution) over a period of 3 to 5 minutes. This technique is intended to minimize the risk of thrombosis or perivenous extravasation which could lead to severe cellulitis, vesication and tissue necrosis. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration. In case of extravasation the administration should be immediately stopped.

Conventional dose
When epirubicin is used as a single agent, the recommended dose per cycle in Adults is 60-90 mg/m² of body surface area. The drug should be injected intravenous over 3-5 minutes and depending on the patient’s hematomedullary status, the dose should be repeated at 21 day intervals.

High dose
Epirubicin hydrochloride as a single agent for the high dose treatment of lung cancer should be administered according to the following regimens:

• Small cell lung cancer (previously untreated): 120 mg/m² day 1, every three weeks.
• Non-small cell lung cancer (squamous, large cell and adenocarcinoma, previously untreated): 135 mg/m² day 1 or 45 mg/m² days 1, 2, 3, every three weeks.

Epirubicin hydrochloride may be given as an intravenous bolus over 3-5 minutes or as an infusion up to 30 minutes.

Lower doses (60-75 mg/m² for conventional doses schedules or 105-120 mg/m² for high dose schedules) are recommended for patients whose bone marrow function has already been impaired by previous chemotherapy or radiotherapy, by age, or neoplastic bone marrow infiltration. The total dose per cycle may be divided over 2-3 successive days. When the drug is used in combination with other antitumor agents, the dose needs to be adequately reduced.

Intravesical administration
For the treatment of superficial bladder tumors, a therapy of 8 weekly instillations of 50 mg (in 25-50 ml of saline solution) is recommended. In the case of local toxicity (chemical cystitis), a dose reduction to 30 mg is advised. For carcinoma-in-situ, depending on the individual tolerability of the patient, the dose may be increased up to 80 mg. It should not be used in this way for the treatment of invasive tumors which have penetrated the bladder wall where systemic therapy or surgery is more appropriate. For prophylaxis of recurrences after transurethral resection of superficial tumors, 4 weekly administrations of 50 mg followed by 11 monthly instillations at the same dosage are recommended. Generally, the instillate should be retained in the bladder for one hour and during installation the pelvis of the patient should be rotated to ensure the most extensive contact of the solution with the vesical mucosa. To avoid undue dilution with the urine, the patient should be instructed not to drink any fluid in the twelve hours prior to instillation.