ALKERAN TABLET 2 mg (Revised formula)

TABLET, FILM COATED

**Dosage and Administration** **General** _ALKERAN_ is a cytotoxic drug which falls into the general class of alkylating agents. It should be prescribed only by physicians experienced in the management of malignant disease with such agents. Since _ALKERAN_ is myelosuppressive, frequent blood counts are essential during therapy and the dosage should be delayed or adjusted if necessary ( _see Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The absorption of _ALKERAN_ after oral administration is variable. Dosage may need to be cautiously increased until myelosuppression is seen, in order to ensure that potentially therapeutic levels have been reached. **Multiple myeloma** A typical oral dosage schedule is 0.15 mg/kg bodyweight/day in divided doses for 4 days repeated at intervals of 6 weeks. Numerous regimens have, however, been used and the scientific literature should be consulted for details. The administration of oral _ALKERAN_ and prednisone may be more effective than _ALKERAN_ alone. The combination is usually given on an intermittent basis. Prolonging treatment beyond one year in responders does not appear to improve results. **Advanced ovarian adenocarcinoma** A typical regimen is 0.2 mg/kg bodyweight/day orally for 5 days. This is repeated every 4 to 8 weeks, or as soon as the peripheral blood count has recovered. **Carcinoma of the breast** _ALKERAN_ has been given orally at a dose of 0.15 mg/kg bodyweight or 6 mg/m2 body surface area/day for 5 days and repeated every 6 weeks. The dose was decreased if bone marrow toxicity was observed. **Polycythaemia rubra vera** For remission induction, doses of 6 to 10 mg daily for 5 to 7 days have been used, after which 2 to 4 mg daily were given until satisfactory disease control was achieved. A dose of 2 to 6 mg once per week has been used for maintenance therapy. In view of the possibility of severe myelosuppression if _ALKERAN_ is given on a continuous basis, it is essential that frequent blood counts are taken throughout therapy, with dosage adjustment or breaks in treatment, as appropriate, to maintain careful haematological control. **Use in children** _ALKERAN_ within the conventional dosage range, is only rarely indicated in children and absolute dosage guidelines cannot be provided. **Use in the elderly** Although _ALKERAN_ is frequently used at conventional dosage in the elderly, there is no specific information available relating to its administration to this patient subgroup. **Dosage in renal impairment** ( _See Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _ALKERAN_ clearance, though variable, is decreased in renal impairment. Currently available pharmacokinetic data do not justify an absolute recommendation on dosage reduction when administering _ALKERAN_ tablets to patients with renal impairment, but it may be prudent to use a reduced dosage initially until tolerance is established.