Other safety alerts
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| Cotellic™ (cobimetinib): Important Drug Warning: Additional cases of severe haemorrhage |
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Roche Hong Kong Limited (Roche HK), a registration certificate holder of pharmaceutical product, informed the Department of Health (DH) that additional cases of severe haemorrhage have been reported with Cotellic™ (cobimetinib).
Roche HK informed healthcare professionals on the following:
• Post-marketing safety reports and ongoing clinical trials have identified additional severe haemorrhage events in patients receiving Cotellic, including intracranial and gastrointestinal tract bleeds.
• Cotellic should be used with caution when given to patients with additional risk factors for bleeding, such as brain metastases, and/or concomitant medications that increase the risk of bleeding including antiplatelet or anticoagulant therapy.
• Dose modification advice for Hemorrhage events includes the following
- For Grade 4 hemorrhage event or cerebral hemorrhage of all grades:
- Interrupt Cotellic treatment. Permanently discontinue Cotellic for hemorrhage events attributed to Cotellic.
- For Grade 3 events:
- Interrupt Cotellic treatment. There is no data on the effectiveness of Cotellic dose modification for hemorrhage events. Clinical judgment should be applied when considering restarting Cotellic treatment. Zelboraf dosing can be continued when Cotellic treatment is interrupted if clinically indicated.
Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Roche HK advised that as described in the current product information, haemorrhage is an 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. At the time of the analysis, a total of thirty cases of severe haemorrhage have been reported from an estimated 2817 patients exposed to Cotellic. These severe haemorrhage events include 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. To appropriately represent this risk, the Cotellic product information will be updated to add haemorrhage events to the Warnings and Precautions section of the product information along with dose modification advice.
Roche HK advised healthcare professionals to discuss the risks that may be associated with Cotellic therapy with patients and their caregivers.
In Hong Kong, Cotellic Tablets 20mg (HK-64797) is a pharmaceutical product registered by Roche HK, and is a prescription only medicine. Roche HK notified DH that the company is going to issue a “Dear Healthcare Professional Letter” to oncologist and pharmacists on the above risk. So far, DH has not received any adverse drug reaction report related to the product. DH will maintain close contact with Roche HK to monitor any action deemed necessary, and remain vigilant on any safety update regarding the product by overseas drug regulatory authorities.
Ends/ Wednesday, January 11, 2017
Issued at HKT 09:00
As confirmed with Roche HK, the "Dear Healthcare Professional Letter" on additional cases of severe haemorrhage reported with Cotellic™ (cobimetinib) was issued to local oncologists and pharmacists on 11 January 2017.
Content last updated: Thursday, June 1, 2017 |
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