Source: Health Products Regulatory Authority (IE) Revision Year: 2013 Publisher: Aspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland
In the treatment of leukaemias, particularly acute myeloblastic leukaemia and acute lymphoblastic leukaemia.
Lanvis is also used in the treatment of chronic granulocytic leukaemia.
The exact dose and duration of administration will depend on the nature and dosage of other cytotoxic drugs given in conjunction with Lanvis.
Lanvis is variably absorbed following oral administration and plasma levels may be reduced following emesis or intake of food.
Lanvis can be used at any stage prior to maintenance therapy in short term cycles e.g. induction, consolidation, intensification. However it is not recommended for use during maintenance therapy or similar long term continuous treatments due to the high risk of liver toxicity (see Warnings and precautions and Adverse reactions).
For adults, the usual dosage of Lanvis is between 60 and 200 mg/m² body surface area per day.
For children, similar dosages to those used in adults, with appropriate correction for body surface area, have been used.
There are no specific dosage recommendations in elderly patients (see Dosage in renal or hepatic impairment).
Lanvis has been used in various combination chemotherapy schedules in elderly patients with acute leukaemia at equivalent doses to those used in younger patients.
Consideration should be given to reducing the dosage in patients with impaired hepatic or renal function.
Signs: The principal toxic effect is on the bone-marrow and haematological toxicity is likely to be more profound with chronic overdosage than with a single ingestion of Lanvis.
Treatment: As there is no known antidote the blood picture should be closely monitored and general supportive measures, together with appropriate blood transfusion instituted if necessary.
5 years.
Do not store above 25°C. Store in the original bottle and in the carton in order to protect from light. Keep the bottle tightly closed in order to protect from moisture.
Lanvis tablets are supplied in amber (Type III) glass bottles with a polypropylene/HDPE child-resistant closure, containing 25 tablets.
It is recommended that the handling of Lanvis tablets follows the “Guidelines for the Handling of Cytotoxic Drugs” issued by the Royal Pharmaceutical Society of Great Britain Working Party on the Handling of Cytotoxic Drugs. If halving of a tablet is required, care should be taken not to contaminate the hands or inhale the drug. Pregnant staff should not handle cytotoxic agents.
Any unused product or waste material should be disposed of in accordance with local requirements.
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