其 他 安 全 警 示
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| The United Kingdom: Ponatinib (Iclusig▼): reports of posterior reversible encephalopathy syndrome (English Only) |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that post-marketing cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving ponatinib; the risk could be up to 1 in 100 people taking the medicine.
A routine European Union (EU) review assessed cases of PRES reported in patients receiving ponatinib. In a cumulative review, 5 cases of PRES were identified, 2 of which were confirmed with MRI. Two cases showed a positive de-challenge effect (symptoms improved after ponatinib withdrawal). In both cases, signs and symptoms of PRES did not reappear when ponatinib was restarted at a lower dose (negative re-challenge at reduced dose).
Risk of PRES has been added to the list of adverse events associated with ponatinib in the Summary of Product Characteristics and Patient Information Leaflet with a frequency of uncommon (could affect up to 1 in 100 people taking the medicine).
No United Kingdom (UK) Yellow Card reports have been received for PRES association with ponatinib treatment, but use in the UK is low and continued vigilance is recommended.
PRES is a neurological disorder that can present with signs and symptoms such as seizure, headache, decreased alertness, altered mental functioning, vision loss, and other visual and neurological disturbances. Characteristic radiographic findings include bilateral regions of subcortical vasogenic oedema that resolve within days or weeks. Hypertension including hypertensive crisis is an established reaction associated with ponatinib treatment and may contribute to the risk of PRES.
Healthcare professionals are advised to interrupt treatment if PRES is confirmed and resume treatment only once the event is resolved and if the benefit of continued treatment outweighs the risk of PRES, and advise patients to contact their healthcare professional immediately if they develop sudden-onset severe headache, confusion, seizures, or vision changes.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/ponatinib-iclusig-reports-of-posterior-reversible-encephalopathy-syndrome
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Oct 12, 2018
Issued at HKT 17:00
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