Hemlibra Approved for Hemophilia A Patients Without Inhibitors
Genentech announced the US Federal Drug Administration, FDA, approval of Hemlibra for routine treatment in adults and children, ages newborn and older, with hemophilia A without inhibitors. Hemlibra can be administered subcutaneously (under the skin) at multiple dosing options: once weekly, every two weeks, and every four weeks. Subcutaneous treatment is quite different from the current intravenous treatment, in which factor VIII is injected directly into a vein. This new expanded FDA approval is based on positive results from the phase III HAVEN 3 and HAVEN 4 studies. The therapy was already FDA approved (November 2017) for treatment in adults and children with hemophilia A with inhibitors.
Hemlibra does not replace missing factor VIII. Hemlibra is the first drug approved that stops bleeding by bridging factor IXa and factor X using a monoclonal antibody. Hemlibra is dosed in milligrams, unlike factor VIII, which is dosed in international units. The product is available in four different sizes: 30 mg, 60 mg, 105 mg, and 150 mg single use vials. The dosage is based on body weight. It may be stored in the refrigerator up to the expiration date printed on each vial, or at room temperature for a total of seven days.
The most common adverse reactions occurring in 10% or more of people treated with Hemlibra include injection site reactions, headaches, and joint pain. Hemlibra may interfere with laboratory tests that measure how well blood is clotting and may cause a false reading. Patients should talk to their healthcare provider about how this may affect their care. If you are interested in learning more about Hemlibra, please read the patient information on the Hemlibra website and contact your hemophilia treatment center. The Hemophilia of Georgia and Beacon pharmacies are working with commercial and government payers to gain coverage for clients. We will be glad to answer any questions you may have.