Why do we 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 patients 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 healthcare professionals (HCPs).
What are some limitations of the content in this website?
This website is not a comprehensive source of safety information on emicizumab-kxwh. Due to the voluntary nature of postmarketing adverse event reporting, information may be missing, duplicative, and/or incomplete. We evaluate these reports through our drug safety department, and attempt to verify the information to the extent possible. Additionally, the existence of an adverse event report does not establish causation. 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. Some of the investigations and assessments may be ongoing, and therefore the information is subject to change.
What are postmarketing adverse event reports?
An adverse event is an untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, whether or not related to a drug. A postmarketing adverse event report is defined on this site as a report received by Genentech regarding an adverse event that occurs after FDA approval of emicizumab-kxwh, meets adverse event reporting criteria, and 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 present adverse event information for thrombotic microangiopathy, serious thrombotic events, and fatalities?
This website was developed to provide timely and accurate information on targeted serious adverse events of interest for HEMLIBRA, specifically thrombotic microangiopathy, serious thrombotic events, as well as fatal events. Genentech has received multiple inquiries regarding these specific serious adverse events in patients who received emicizumab-kxwh. We understand there may be concerns regarding these serious events in people taking HEMLIBRA, and we are committed to being transparent about them. This website serves as just one of the ways in which we plan to communicate safety information about these events; the Prescribing Information remains the primary source of information.
How does Genentech/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 commercialization. All adverse event reports received by Genentech/Roche are reviewed and assessed to obtain the most complete and accurate information possible. The reports are then submitted to the FDA and other health authorities 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 postmarketing adverse event reports received by Genentech/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 postmarketing cases 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?
The current plan is for the website to be updated at least quarterly.
How do I get more information on the safety of emicizumab-kxwh?
The Prescribing Information is the primary source of
information on the known and potential risks of emicizumab-kxwh
for hemophilia A with or without FVIII inhibitors. You may contact our
Medical Communications department or a Medical Science Liaison (MSL) for any questions
you may have regarding emicizumab-kxwh.