See updated dose advice for some patients who have achieved a major cytogenetic response on ponatinib (Iclusig▼).
Article date: November 2014
Ponatinib (Iclusig▼) is a treatment for adults with chronic myeloid leukaemia or Philadelphia-chromosome-positive acute lymphoblastic leukaemia. Its authorised use is restricted to patients who have limited alternative treatment options with tyrosine kinase inhibitors. For full information on the authorised indication, please see the summary of product characteristics.
In December 2013 we told you of the risk of serious vascular occlusive events with ponatinib (Iclusig▼) and highlighted preliminary advice on risk minimisation. An in-depth EU review of this risk has now been completed. The full recommendations have been published by the European Medicines Agency.
To summarise, the available evidence shows that the risk of blood vessel blockage with ponatinib is likely to be dose-dependent. However, the data are insufficient to recommend reducing the ponatinib dose. Also, there is a risk that a lower dose might not be as effective as the current dose in all patients and in long-term treatment. Therefore, the recommended starting dose of ponatinib remains at 45 mg once a day.
The product information will be updated with strengthened warnings about the risks associated with ponatinib. The latest evidence will also be added in case you wish to consider reducing the dose in patients with chronic phase chronic myeloid leukaemia who are responding well to treatment, and who might be at high risk of blood vessel blockage. Stop ponatinib if a complete response has not occurred within 3 months of treatment and monitor patients for high blood pressure or signs of heart problems.
Call for reporting
Please continue to report any suspected adverse reactions to ponatinib or any other medicine via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard)
Article citation: Drug Safety Update volume 8 issue 4, November 2014: S2
Published 11 December 2014