In the completed trial of 51 previously treated children, there were 0after 6 months on KOVALTRY®.1
Children with a history of inhibitors and those new to treatment were not included in the trial. Children with hemophilia A may develop inhibitors to rFVIII.1
In an ongoing study, one 13-year-old previously treated child tested positive for a low-titer inhibitor. His ABR was 0 and no change in treatment was required.1
The common side effects of KOVALTRY are headache, fever, and itchy rash, in addition to inhibitors in patients who were not previously treated or minimally treated with Factor VIII products.1
For additional safety information,.
KOVALTRY® is a medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.
KOVALTRY is used to treat and control bleeding in adults and children with hemophilia A. KOVALTRY can reduce the number of bleeding episodes in adults and children with hemophilia A when used regularly (prophylaxis). Your healthcare provider may give you KOVALTRY when you have surgery.
KOVALTRY is not used to treat von Willebrand Disease.
IMPORTANT SAFETY INFORMATION
You should not use KOVALTRY if you are allergic to rodents (like mice and hamsters) or any ingredients in KOVALTRY.
Tell your healthcare provider if you have heart disease or are at risk for heart disease.
The common side effects of KOVALTRY are headache, fever, and itchy rash, in addition to inhibitors in patients who were not previously treated or minimally treated with Factor VIII products.
Your body may make antibodies, called “inhibitors” against KOVALTRY, which may stop KOVALTRY from working properly. If your bleeding is not adequately controlled, it could be due to the development of Factor VIII inhibitors. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
Allergic reactions may occur with KOVALTRY. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, and nausea.
Tell your healthcare provider about any side effect that bothers you or that does not go away.
Call your healthcare provider right away if bleeding is not controlled after using KOVALTRY.
For additional important risk and use information, please see full Prescribing Information.
Reference: 1. KOVALTRY® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016.
You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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Site Last Modified 02/2021