Ponatinib (Iclusig▼): risk of vascular occlusive events—updated advice on possible dose reduction
- Medicines and Healthcare products Regulatory Agency
- 24 April 2017
- Therapeutic area:
- Cancer and Haematology
Prescribers should consider reducing the dose of ponatinib to 15 mg a day for patients with chronic phase chronic myeloid leukaemia (CP-CML) who have achieved a major cytogenetic response.
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, see the summary of product characteristics.
In November 2014, we informed you about the conclusions of a European-level review of the risk of serious vascular occlusive events with ponatinib and highlighted advice on risk minimisation. Additional long-term follow-up data are now available that provide further information and support new advice on dose modifications to reduce this risk.
The available evidence shows that the risk of arterial occlusion with ponatinib is likely to be dose-dependent and that dose reduction may therefore reduce the risk of life-threatening vascular events. The additional data from long-term follow-up of clinical trial patients with chronic phase chronic myeloid leukaemia (CP-CML) who have undergone dose reduction after achieving a major cytogenetic response provide reassurance that ponatinib continues to be effective in maintaining this response when a lower dose is taken.
The recommended starting dose of ponatinib remains at 45 mg once a day for all patients.
Prescribers should consider reducing the dose of ponatinib to 15 mg a day for patients with CP-CML who have achieved a major cytogenetic response while on treatment.
The following factors should be taken into account in the individual patient assessment:
side effects of ponatinib therapy (including cardiovascular and other dose-related toxicity)
time to cytogenetic response
BCR-ABL transcript levels
If dose reduction is undertaken, close monitoring of response is recommended.
Call for reporting
Please continue to report any suspected adverse reactions via the Yellow Card Scheme.
Article citation: Drug Safety Update volume 10, issue 9, April 2017: 2.
Published: 24 April 2017