Transcription of and consider a change in treatment - Genentech
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and consider a change in treatment - Genentech
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HEMLIBRA safely and effectively. See full prescribing information for HEMLIBRA. HEMLIBRA (emicizumab-kxwh) injection, for subcutaneous use Initial Approval: 2017 RECENT MAJOR CHANGES Dosage and Administration, Preparation and Administration ( ) 06/2020 Warnings and Precautions ( , ) 03/2021 Warnings and Precautions, Immunogenicity ( ) 12 /2021 INDICATIONS AND USAGE HEMLIBRA is a bispecific factor IXa- and factor X-directed antibody 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 (congenital factor VIII deficiency) with or without factor VIII inhibitors.
factor VIII (FVIII) inhibitor titers. Intrinsic pathway clotting-based laboratory tests should not be used. (5.4, 7.2) ADVERSE REACTIONS Most common advers e reactions (incidence ≥ 10%) are injection site reactions, headache, and arthralgia. (6.1)
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