This is a medical website developed by healthcare professionals at Genentech/Roche and is intended to provide US healthcare professionals with information regarding emicizumab from available clinical research data, real-world data and data from registries. Our aim is to share new data and findings from ongoing studies and real world use with emicizumab, to give an up-to-date, full and comprehensive summary of emicizumab’s long-term safety and efficacy outcomes, providing valuable information that we hope will allow more informed treatment decision making.
You may read our letter to the hemophilia community from September 2020 about this website here.
A website has been developed for US patients and caregivers and may be accessed at www.emipatientinfo.com. The patient and caregiver website is intended to provide patients and caregivers with information on topics of interest for emicizumab, including patient-friendly summaries of these information. The information provided is only for educational purposes and is intended to support informed and meaningful treatment discussions between patients and their healthcare providers.
Further, we will ensure patient organizations receive the appropriate information regarding the safety and efficacy of emicizumab in a timely manner, so they may inform the patient communities that they serve. Patients and their caregivers should speak with their treating physician or local patient organizations, if they have any questions in respect to their hemophilia management. The Hemlibra Prescribing Information, as approved by the US Food and Drug Administration (FDA), should always be the primary source of information on the safety and efficacy of the medicine.
Updates on the number of fatalities in people treated with emicizumab, whether known to be related to emicizumab or not, are and will continue to be included in public safety registries and databases, such as FAERS (FDA Adverse Event Reporting System).
In regards to providing case details or causality, we are not able to provide extensive information related to serious adverse events or fatalities reported in the post-approval setting because the level of detail available and Genentech/Roche's ability to confirm individual details is variable. In addition, the information on adverse events provided to Genentech/Roche from consumers or physicians after approval is confidential, and detailed information cannot be shared without the consent of the reporting person, the patient or patient’s family. Patient privacy is very important to Genentech/Roche, so we are also careful not to disclose specific details about an adverse event that could jeopardize the privacy of either the patient or their family, or breach patient confidentiality.
We have worked with experts in the field to develop a series of manuscripts reviewing mortality in hemophilia A and using this to establish a framework to further assess the reported fatalities in people receiving emicizumab. These manuscripts were published in the Journal of Thrombosis and Hemostasis in December 2020 and can be found on this website under the Publications and Scientific Presentations/Hemophilia A and Mortality section.