ALKERAN Ref.[4460] Active ingredients: Melphalan

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.

Multiple myeloma: A typical oral dosage schedule is 0.15mg/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 0.2mg/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 6mg/m² body surface area/day for 5 days and repeated every 6 weeks. The dose was decreased if bone marrow toxicity was observed.

Polycythemia vera: For remission induction doses of 6 to l0mg daily for 5 to 7 days have been used, after which 2 to 4mg daily were given until satisfactory disease control was achieved. A dose of 2 to 6mg 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 treatment, as appropriate, to maintain careful haematological control.

Use in children: Alkeran 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 sub-group. However, caution should be taken where there is renal impairment.

Dosage in renal impairment: (see also Special Warnings and Special Precautions for Use). 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.

Symptoms and signs

Gastro-intestinal effects, including nausea, vomiting and diarrhoea are the most likely early signs of acute oral overdosage.

Treatment

General supportive measures, together with appropriate blood and platelet transfusions, should be instituted if necessary and consideration given to hospitalisation cover with anti-infective agents, and the use of haematological growth factors.

There is no specific antidote. The blood picture should be closely monitored for at least four weeks following overdosage until there is evidence of recovery.

3 years.

Store in a refrigeration 2°C to 8°C.

Alkeran Tablets are supplied in amber glass bottles of 25 or 50 tablets with a child-resistant closure.

Not all pack sizes may be marketed.

The handling of Alkeran formulations should follow guidelines for the handling of cytotoxic drugs according to prevailing local recommendations.

Pregnant Staff should not handle cytotoxics. Protective clothing, including gloves, should be worn.

Alkeran Tablets should not be divided.

Provided the outer coating of the tablet is intact, there is no risk in handling Alkeran Tablets.

Disposal

Alkeran Tablets should be destroyed in accordance with relevant local regulatory requirements concerning the disposal of cytotoxic drugs.

Adequate care should be taken in the disposal of waste material, including containers and any other contaminated material.