KOVALTRY Treatment
for Adolescents and Adults
LEOPOLD I: Main Study
Study Design
62 previously treated adolescents and adults (aged 12 to 65 years) with severe hemophilia A were studied for 1 year. Doctors studied bleeds per year, choosing either 2x/week prophylaxis (18 people) or 3x/week prophylaxis (44 people) 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.
LEOPOLD I: 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 and efficacy profile of treatment with KOVALTRY (up to 2 years of treatment in the main and extension period).
Patients aged 12 to 17 years (N=10) and aged ≥18 years (N=52) who completed the 1-year main study period could be enrolled in the extension to collect additional safety and efficacy data.
Of these 55 patients, 8 patients were 12 to 17 years of age and 47 patients were ≥18
*43 patients completed the extension study
Efficacy3
Median percentage of joint bleeds affecting target joints decreased from main to extension study, and median time to first bleed was prolonged from main to extension study.3
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.
*A myocardial infarction occurred in one patient with known risk factors for cardiovascular events. The event was determined not to be related to the specific study drug. The patient recovered after two weeks.
†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.
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. Saxena K, Lalezari S, Oldenburg J, et al. Efficacy and safety of BAY 81-8973, a full-length recombinant factor VIII: results from the LEOPOLD I trial. Haemophilia. 2016;22(5):706-712. 3. Bayer Data on File, April 2024. LEOPOLD I Extension. BAY 81-8973. 12594 Extension. Clinical Study Report Addendum 1, PH37225.
