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Background

Ponatinib (Iclusigâ–�) 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 .

Updated data

In November 2014, we informed you about the conclusions of a 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.

»Ê¹ÚÌåÓýapp 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. »Ê¹ÚÌåÓýapp 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.

Dose advice

»Ê¹ÚÌåÓýapp 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.

»Ê¹ÚÌåÓýapp following factors should be taken into account in the individual patient assessment:

• cardiovascular risk

• 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 .

Article citation: Drug Safety Update volume 10, issue 9, April 2017: 2.