CHMP recommends restricting use of ponatinib
- PDF / 113,667 Bytes
- 1 Pages / 595.245 x 841.846 pts (A4) Page_size
- 90 Downloads / 174 Views
1
CHMP recommends restricting use of ponatinib Changes in the use of ponatinib [Iclusig] have been recommended to help minimise the risk of occlusive vascular events, according to an EMA press release. The recommendations follow a review by the EMA’s CHMP of updated clinical trial data indicating a higher incidence or arterial and venous thrombotic events in patients receiving ponatinib than that observed at the time of marketing authorisation. The CHMP recommends that ponatinib should not be used in patients with a history of myocardial infarction or stroke unless the potential benefits of treatment outweigh the risks. Before starting treatment with ponatinib, the cardiovascular status of patients should be assessed and cardiovascular risk factors managed actively. During treatment, patients’ cardiovascular status should be monitored and hypertension well controlled. If hypertension is not controlled, treatment with ponatinib may need to be discontinued. Patients should also be monitored for any signs of vascular occlusion or thromboembolism. Treatment should be discontinued immediately if any such signs occur. A review of relevant data for a benefit-risk assessment will be conducted by the EMA.* * See also Reactions 1477 p2; 803095471 EMA. European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots. Internet Document : [3 pages], 22 Nov 2013. Available from: URL: http:// 803096494 www.ema.europa.eu
0114-9954/13/1481-0001/$14.95 Adis © 2013 Springer International Publishing AG. All rights reserved
Reactions 7 Dec 2013 No. 1481
Data Loading...
