Other safety alerts
|
| |
| Singapore: Risk of pancreatitis associated with vemurafenib |
| |
Vemurafenib (Zelboraf®, Roche Singapore Pte Ltd) is a low molecular weight inhibitor of BRAF serine-threonine kinase. It has been registered locally since February 2013 for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Reviews on the risk of pancreatitis have been conducted by the EMA and Health Canada. Details of the reviews can be found in the HSA's website.
To date, HSA has not received any adverse reaction report of pancreatitis associated with vemurafenib. The local package insert (PI) for Zelboraf® currently lists pancreatitis as an uncommon adverse drug reaction. In view of overseas safety signals, the Singapore PI has been strengthened to include information on patient monitoring and detection of pancreatitis.
Healthcare professionals are advised to remain vigilant to the possible signs and symptoms of pancreatitis in patients who are prescribed vemurafenib, and to consider the possibility of pancreatitis in the event of unexplained abdominal pain.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../risk-of-pancreatitisassociatedwithvemurafenib.html
In Hong Kong, Zelboraf Film-coated Tab 240mg (HK-61970) is a registered pharmaceutical product, and is a prescription-only medicine. Related news has been issued by Health Canada, and was posted on the Drug Office website on 13 February 2015. Letters to inform local healthcare professionals of the warning were issued on the same day. So far, the Department of Health (DH) has not received any adverse drug reaction case on vemurafenib. The package insert of Zelboraf has already included the warning on pancreatitis. DH will remain vigilant on any safety updates of the drug.
Ends/ Thursday, October 08, 2015
Issued at HKT 15:00
|
| |
|
