Exploring the LEOPOLD Kids Part A trial

KOVALTRY® was studied to determine its effectiveness and safety in children, in a trial called LEOPOLD Kids Part A1

Clinical Trial Study Setup - Children

There were 51 previously treated children (0 to 12 years old) with severe hemophilia A in LEOPOLD Kids Part A, studied for 6 months.1

Clinical Trial Outcomes - Children

Doctors studied annual bleed rate (ABR), choosing either 2x/week prophylaxis (22 children), or 3x/week or every‑other‑day prophylaxis (29 children) based on each child's needs.1

Clinical Trial – Dosing - Children

These dosing regimens were chosen because they most closely resemble the way doctors prescribe treatment for their younger patients.2

INDICATIONS

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.

References: 1. KOVALTRY® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016. 2. Coppola A, Di Capua C, De Simone C. Primary prophylaxis in children with haemophilia. Blood Transfus. 2008;6(suppl 2):s4-s11.

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