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Genentech Notice on COVID-19, Hemlibra®, and Laboratory Assays

April 16, 2020
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Genentech recently distributed a notice relevant to its product Hemlibra®, reminding health care providers that it is known to interfere with certain laboratory assays used to measure blood coagulation. These tests are often used for patients with bleeding disorders such as hemophilia, and to diagnose and monitor individuals suffering from other conditions that affect coagulation such as disseminated intravascular coagulation (DIC), an uncommon yet serious condition that triggers abnormal clotting in the body’s blood vessels. This is an important point as severe COVID-19 patients, with or without hemophilia, may develop a COVID-19-associated coagulopathy resembling DIC. Further, physicians and laboratories encountering COVID-19 patients may not be very familiar with Hemlibra® and its ability to affect key assay results.

The notice which was addressed to HTCs, physicians, and other healthcare providers, includes a chart encompassing the assays most commonly used to diagnose, monitor, and manage patients with COVID-19-associated coagulopathy, whether these assays are affected by Hemlibra®, and possible alternatives where applicable.

Hemlibra® is currently indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors.

While this information is known within the hemophilia community, if an individual on Hemlibra® seeks treatment due to symptoms of COVID-19 infection, we recommend the above table or information is communicated proactively to the treating healthcare provider to ensure they are aware of this information and to remind them to consult the U.S. Prescribing Information. The long half-life (~30 days) of Hemlibra® should also be taken into consideration in the context of clinical management. Please consult U.S. Prescribing Information in all cases.”

The most up-to-date recommendations relevant to Hemlibra® are provided by NHF’s Medical and Scientific Advisory Council (MASAC) including a brief description of the therapy, its indications, and information meant to help inform treatment decisions relevant to the use of the product.
View and download Recommendation on the Use and Management of Emicizumab-kxwh (Hemlibra®) for Hemophilia A with and without Inhibitors.

Source: Genentech, April 14, 2020