Frequently asked questions
These are a few of the questions you may have about hemophilia A and KOVALTRY®
About 1 in every 5,000 males in the U.S. is born with hemophilia A.1
Hemophilia A is genetic, or inherited. There is a gene that determines how the body makes Factor VIII, and that gene is different for people with hemophilia A.1
Factor VIII is a protein in the body that helps blood to clot. People with hemophilia A produce less Factor VIII naturally.1
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.
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.
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.
Your body can also make antibodies, called "inhibitors," against KOVALTRY®, which may stop KOVALTRY® from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
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®.
These are not all the possible side effects with KOVALTRY®. You can ask your healthcare provider for information that is written for healthcare professionals.
KOVALTRY® is an unmodified version of the primary protein structure of Factor VIII.2
In unmodified, full length Factor VIII, no other molecules have been added to the protein structure, and no parts of the Factor VIII protein have been removed.
Prophylaxis treatment in hemophilia A is regular treatment to reduce bleeding, before bleeds actually happen.
On-demand treatment in hemophilia A is treatment of bleeds as they happen.
ABR, or annual bleed rate, is the number of bleeds a person would experience in a year.
An inhibitor is an antibody that your body can produce, which may stop Factor VIII products from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
During a protein's development, folding occurs so the protein is shaped into its correct, 3-dimensional structure.3
The KOVALTRY® manufacturing process uses a microscopic, 20-nm filter designed to remove potential viruses—even those that are very small. There are 10 million nanometers in a single centimeter2
Half-life is how long it takes for the amount of drug in the body to be reduced by one half.
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.
