Intervene in the sickle cell disease ( SCD ) cascade
Oxbryta directly inhibits hemoglobin S ( HbS ) polymerization 1 , 2
Reduces red blood cell ( RBC ) sickling
Reduces hemolysis as measured in the secondary endpoint by indirect bilirubin ( -29 % vs -3 %) and percent reticulocyte count ( -20 % vs 5 %) vs baseline compared to placebo . Mean Hb improvement in the Oxbryta group was 1.1 g / dL at 24 weeks
Improves anemia as measured in the primary endpoint of greater than 1 g / dL hemoglobin ( Hb ) increase vs baseline ( 51 % vs 7 %) compared to placebo
Convenient oral dosing 3 tablets once a day , with or without hydroxyurea
INDICATIONS AND USAGE
Oxbryta is indicated for the treatment of sickle cell disease ( SCD ) in adults and pediatric patients 12 years of age and older .
This indication is approved under accelerated approval based on increase in hemoglobin ( Hb ). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial ( s ).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Oxbryta is contraindicated in patients with a history of serious drug hypersensitivity reaction to voxelotor or excipients .
WARNINGS AND PRECAUTIONS Hypersensitivity Reactions
Serious hypersensitivity reactions after administration of Oxbryta have occurred in < 1 % of patients treated . Clinical manifestations may include generalized rash , urticaria , mild shortness of breath , mild facial swelling , and eosinophilia .
If hypersensitivity reactions occur , discontinue Oxbryta and administer appropriate medical therapy . Do not reinitiate Oxbryta in patients who experience these symptoms with previous use .
Laboratory Test Interference
Oxbryta administration may interfere with measurement of Hb subtypes by ( HbA , HbS , and HbF ) HPLC . If precise quantitation of Hb species is
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