KOVALTRY Treatment for Children
LEOPOLD Kids: Main Study
Part A Study Design
51 previously treated children (aged 0 to <12 years) with severe hemophilia A were studied for 6 months. Doctors studied bleeds per year, choosing either 2x/week prophylaxis (22 children), or 3x/week or every-other-day prophylaxis (29 children) based on individual needs.
Definitions of PK Terms
- Area under the curve A measure of the overall amount of a drug in the bloodstream over time after a dose.
- Maximum concentration The highest amount of a drug in the blood measured after a dose. For a FVIII treatment, this is sometimes called FVIII level, and is measured in international units per deciliter (IU/dL).
- Half-life How much time it takes for the amount of a drug in the blood to decline by one half.
- These measures are all related to FVIII levels in the blood over time—from the time that the treatment is infused to the time that it’s eliminated from the body.
- a Only Chromogenic Substrate Assay was used for PK parameter assessment in LEOPOLD Kids.
- b n=5
- c One subject considered PK outlier was excluded.
LEOPOLD Kids: Main and Extension Study
Extension Study Design3
The extension was an optional continuation of the prophylaxis treatment for up to 12 additional months, during which time patients were treated with KOVALTRY. The extension study aimed to assess the long-term safety of KOVALTRY in previously treated patients who had been treating with KOVALTRY for 100 accumulated days across the main and extension studies.
Patients ages 0 to <6 years (n=25) and ages 6 to <12 years (n=26) could roll over after reaching at least 50 days of treatment with KOVALTRY, in order to achieve at least 100 cumulative days of treatment with KOVALTRY.
*45 patients completed the extension study
Safety1,2,3
The common side effects of KOVALTRY are fever, headache and rash in addition to inhibitors in patients who were not previously treated or minimally treated with Factor VIII products.
No confirmed cases of neutralizing antibodies (inhibitors) to FVIII occurred.
*People with a history of inhibitors or new to FVIII therapy were not included in the trials. People with hemophilia A may develop inhibitors to rFVIII.
†One 13-year-old previously treated child tested positive for a low-titer inhibitor. His number of bleeds per year (ABR) was 0 and no change in treatment was required.
INDICATION FOR KOVALTRY®
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 fever, headache, and 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; 2021. 2. Ljung R, Kenet G, Mancuso ME, et al; on behalf of the investigators of the LEOPOLD Kids Trial. BAY 81-8973 safety and efficacy for prophylaxis and treatment of bleeds in previously treated children with severe haemophilia A: results of the LEOPOLD Kids Trial. Haemophilia. 2016;22(3):354-360. 3. Bayer Data on File, April 2024. LEOPOLD Kids Extension. BAY 81-8973. 13400 Extension. Clinical Study Report, PH-41325.
