Download Glivec

Glivec®
Active ingredient: Imatinib
Marketing authorisation holder: Novartis Europharm Ltd
Availability: National Health Service
Variations: Data from small retrospective case series and case reports showed that longitudinal bone growth
may be influenced by imatinib. This would occur particularly in pre-pubertal period. The long term effects on
growth in children due to prolonged treatment is still not known. However, these patients should be closely
monitored. Due to limited number of events obtained from literature and spontaneous reports, it is unable to
determine the frequency and reversibility of the impact of drug administration.
A non-randomised open label study was carried out to evaluate the pharmacokinetic effects of imatinib with
paracetamol in newly diagnosed subjects suffering from previously untreated chronic myeloid leukaemia in
chronic phase. In vitro studies have shown that imatinib inhibits O-glucuronidation of paracetamol. However
this was observed in vivo when imatinib 400mg is administered with 1g paracetamol. Since no studies have
been carried out when higher doses of imatinib and paracetamol are administered, caution is recommended.
Reference: European Medicines Agency. Glivec. [online]. 2011 June 29 [cited 2011 July 30]; Available from: URL:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000406/human_med_000808.jsp&murl=menus/medicine
s/medicines.jsp&mid=WC0b01ac058001d124