Why does emicizumab-kxwh have a safety website, and what are the objectives?
Genentech is committed to transparent, timely communication of adverse events associated with the use of emicizumab-kxwh in the prophylactic treatment of people with hemophilia A with or without factor VIII (FVIII) inhibitors. This website is meant to serve as just one of the ways we will provide updated, verified safety information to the hemophilia community, specifically about thrombotic microangiopathy, serious thrombotic events (blood clots), and fatalities in patients taking emicizumab-kxwh, whether or not such events are related to emicizumab-kxwh.
What are some limitations of the content in this website?
This website is not a complete source of safety information for emicizumab-kxwh. Some of the investigations remain ongoing, and therefore the information is subject to change.
The Prescribing Information remains the primary source of information on the known and potential risks of emicizumab-kxwh for hemophilia A with or without FVIII inhibitors.
What are postmarketing adverse event reports?
A postmarketing adverse event report is defined on this website as a report received by Genentech regarding an adverse event that occurs after FDA approval of emicizumab-kxwh. This report meets adverse event reporting criteria, and the event did not occur in a clinical trial, expanded access, or compassionate use.
While reports made in the postmarketing setting are a valuable source of information, they have limitations including that they may be incomplete, inaccurate, untimely, or unverified information. The existence of any given adverse event report does not establish or confirm a causal relationship between emicizumab-kxwh and the reported adverse event.
Why do you only provide adverse event information for thrombotic microangiopathy, thrombotic events (blood clots), and fatalities?
This website was developed to provide timely and accurate information about targeted serious adverse events of interest to the communication for emicizumab-kxwh, specifically thrombotic microangiopathy, serious thrombotic events (blood clots), and all fatal events.
This website serves as just one way in which we communicate safety information about emicizumab-kxwh. The Prescribing Information remains the primary source of information on the known and potential risks of emicizumab-kxwh for hemophilia A with or without FVIII inhibitors.
How do Genentech and Roche verify and report adverse events to the FDA?
Global systems are in place to continuously monitor the safety of a drug, from the time it is first evaluated in clinical studies through the time it is approved and available by prescription.
All adverse event reports received by Genentech and Roche are reviewed and assessed. The reports are then submitted to the FDA as per regulatory requirements.
Are there differences in the reported rates of adverse events between this site and those on the FDA Adverse Event Reporting System (FAERS) database?
Yes, this website includes verified reports of adverse events after FDA approval received by Genentech and Roche. As part of our global pharmacovigilance process, these adverse event reports are reviewed, assessed, and due diligence is performed.
The FAERS database generally includes cases after FDA approval reported by the Market Authorization Holder. However, FAERS may also include reports from clinical trials based on the specific requirements set in FDA regulations along with reports that are submitted voluntarily to the FDA by other resources. As the FDA acknowledges, unverified information, as well as incomplete or duplicate cases, can be reported in the FAERS dashboard.
How often is the website updated?
Genentech is committed to updating this site at least quarterly.
How can I get more information about the safety of emicizumab-kxwh?
Your healthcare provider should be the primary source of information about your medical condition and the safe and effective use of any medicine, including emicizumab-kxwh.
You may contact our Medical Communications department with questions
specific to this site: (800) 821-8590, Monday-Friday, 5:00A – 5:00P
Return to homepage by clicking here.