Risk of severe haemorrhage with Cotellic™ (cobimetinib)

Roche would like to inform healthcare professionals of the risk of severe haemorrhage associated with the use of Cotellic™ (cobimetinib). Haemorrhage is a known adverse drug reaction of Cotellic™. An analysis on post-marketing safety reports and ongoing clinical trials has identified additional severe haemorrhage events in patients receiving Cotellic™, including intracranial and gastrointestinal tract bleeds. In most cases of severe haemorrhage, the patients had additional risk factors for bleeding, such as central nervous system metastasis, pre-existing gastrointestinal disorders, and/or concomitant medications that increase the risk of bleeding, such as antiplatelet or anticoagulant therapy. Healthcare professionals are advised to take into consideration the above safety information when prescribing Cotellic™, and to discuss the risks that may be associated with Cotellic™ therapy with patients and their caregivers.
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.