Alkeran Dosage/Direction for Use

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 Precautions).
Thromboembolic events: ALKERAN in combination with lenalidomide and prednisone or thalidomide and prednisone or dexamethasone is associated with an increased risk of venous thromboembolism (predominantly deep vein thrombosis and pulmonary embolism).
Thromboprophylaxis should be administered for at least the first 5 months of treatment especially in patients with additional thrombotic risk factors. The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors (see Precautions and Adverse Reactions).
If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started. Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, ALKERAN in combination with lenalidomide and prednisone or thalidomide and prednisone or dexamethasone may be restarted at the original dose dependent upon a benefit-risk assessment. The patient should continue anticoagulation therapy during the course of ALKERAN treatment.
Posology: Multiple myeloma: A typical oral dosage schedule is 0.15 mg/kg bodyweight/day in divided doses for 4 days repeated at intervals of six 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 given orally in divided doses for 5 days. This is repeated every 4 to 8 weeks, or as soon as the bone marrow 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 l0 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.
Paediatric population: ALKERAN is only rarely indicated in the paediatric population and absolute dosage guidelines cannot be provided.
Older people: Although ALKERAN is frequently used at conventional dosage in the older people, there is no specific information available relating to its administration to this patient sub‑group. However, caution should be taken where there is renal impairment.
Renal impairment: ALKERAN clearance, though variable, may be decreased in renal impairment (see Precautions).
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.
Method of administration: Oral administration in adults: 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.