LEUKERAN Tablets Ref.[2641] Active ingredients: Chlorambucil

Adults

Hodgkin’s Disease: Used as a single agent in the palliative treatment of advanced disease a typical dosage is 0.2 mg/kg/day for 4-8 weeks. Leukeran is usually included in combination therapy and a number of regimes have been used. Leukeran has been used as an alternative to nitrogen mustard with a reduction in toxicity but similar therapeutic results.

Non-Hodgkin’s Lymphoma: Used as a single agent the usual dosage is 0.1-0.2 mg/kg/day for 4-8 weeks initially, maintenance therapy is then given either by a reduced daily dosage or intermittent courses of treatment. Leukeran is useful in the management of patients with advanced diffuse lymphocytic lymphoma and those who have relapsed after radiotherapy. There is no significant difference in the overall response rate obtained with chlorambucil as a single agent and combination chemotherapy in patients with advanced non-Hodgkin’s lymphocytic lymphoma.

Chronic Lymphocytic Leukaemia: Treatment with Leukeran is usually started after the patient has developed symptoms or when there is evidence of impaired bone marrow function (but not bone marrow failure) as indicated by the peripheral blood count. Initially Leukeran is given at a dosage of 0.15 mg/kg/day until the total leucocyte count has fallen to 10,000 per µL. Treatment may be resumed 4 weeks after the end of the first course and continued at a dosage of 0.1 mg/kg/day.

In a proportion of patients, usually after about 2 years of treatment, the blood leucocyte count is reduced to the normal range, enlarged spleen and lymph nodes become impalpable and the proportion of lymphocytes in the bone marrow is reduced to less than 20 per cent. Patients with evidence of bone marrow failure should first be treated with prednisolone and evidence of marrow regeneration should be obtained before commencing treatment with Leukeran. Intermittent high dose therapy has been compared with daily Leukeran but no significant difference in therapeutic response or frequency of side effects was observed between the two treatment groups.

Waldenstrom’s Macroglobulinaemia: Leukeran is the treatment of choice in this indication. Starting doses of 6-12 mg daily until leucopenia occurs are recommended followed by 2-8 mg daily indefinitely.

Children

Leukeran may be used in the management of Hodgkin’s disease and non-Hodgkin’s lymphomas in children. The dosage regimes are similar to those used in adults.

Use in the Elderly

No specific studies have been carried out in the elderly, however, it may be advisable to monitor renal or hepatic function and if there is serious impairment then caution should be exercised.

Reversible pancytopenia was the main finding of inadvertent overdoses of Leukeran. Neurological toxicity ranging from agitated behaviour and ataxia to multiple grand mal seizures has also occurred. As there is no known antidote the blood picture should be closely monitored and general supportive measures should be instituted, together with appropriate blood transfusion if necessary.

3 years.

Store at 2°C – 8°C.

Leukeran are brown film-coated, round, biconvex tablets engraved “GX EG3” on one side and “L” on the other, supplied in amber glass bottles with a child resistant closure containing 25 tablets.

Leukeran is an active cytotoxic agent for use only under the direction of physicians experienced in the administration of such agents.

Safe handling of Leukeran Tablets: The handling of Leukeran Tablets should follow guidelines for the handling of cytotoxic drugs according to prevailing local recommendations and/or regulations (for example, Royal Pharmaceutical Society of Great Britain Working Party on the Handling of Cytotoxic Drugs).

Provided that the outer coating of the tablet is intact, there is no risk in handling Leukeran Tablets. Leukeran Tablets should not be divided.