Exploring the KOVALTRY® versus Advate® Study
Dosing and PK parameters of KOVALTRY® in a study of adults1
The recommended dosing of KOVALTRY for routine prophylaxis is 20-40 IU/kg 2x/week or 3x/week in adults.
In a study of KOVALTRY, PK parameters were measured after a single 50-IU/kg dose of KOVALTRY in 21 previously treated patients ≥18 years old.
The average area under the curve was 2103.4 IU•h/dL.
The average maximum concentration was 133.1 IU/dL.
The average half-life was 14.2 hours.
PK study of KOVALTRY and Advate®
Half-life and other PK parameters of KOVALTRY and Advate were studied in previously treated adults with severe hemophilia A, aged 18 to 65 years (N=18).
All patients in the study were exposed to both treatments (50-IU/kg infusion) with a washout period (time to allow the drug to be eliminated from the body) between treatments.
FVIII levels were measured for each treatment.
FVIII=Factor VIII.
Definitions of PK terms
Pharmacokinetics, or PK, measures a drug’s activity in the blood, and can help determine how a drug is dosed. There are many different things that are measured during PK testing—half-life and FVIII levels over time are just a couple of these.
Area under the curve: A measure of the overall amount of a drug in the bloodstream over time after a dose.
Concentration: A measure of how much drug is in the blood. For a FVIII treatment, this is sometimes called FVIII level, and is measured in international units per deciliter (IU/dL).
Maximum concentration: The highest amount of a drug in the blood measured after a dose.
Half-life: How much time it takes for the amount of a drug in the blood to decline by one half.
Talk to your healthcare provider about KOVALTRY They can help you schedule a PK test, understand PK results, and find the dosing schedule that’s right for you.
Talk to your healthcare provider about KOVALTRY
They can help you schedule a PK test, understand PK results, and find the dosing schedule that’s right for you.
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.
Reference: 1. KOVALTRY® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2021.
