Frequently asked questions

These are a few of the questions you may have about hemophilia A and KOVALTRY®

How common is hemophilia A?

About 1 in every 5,000 males in the U.S. is born with hemophilia A.1

What causes hemophilia A?

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

What is Factor VIII?

Factor VIII is a protein in the body that helps blood to clot. People with hemophilia A produce less Factor VIII naturally.1

What is KOVALTRY® used for?

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.

What are the possible side effects associated with KOVALTRY®?

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.

How is KOVALTRY® designed to closely match natural Factor VIII?

KOVALTRY® is an unmodified version of the primary protein structure of Factor VIII.2

What is unmodified, full length Factor VIII?

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.

What is prophylaxis treatment in hemophilia A?

Prophylaxis treatment in hemophilia A is regular treatment to reduce bleeding, before bleeds actually happen.

What is on-demand treatment in hemophilia A?

On-demand treatment in hemophilia A is treatment of bleeds as they happen.

What is an ABR?

ABR, or annual bleed rate, is the number of bleeds a person would experience in a year.

What is an inhibitor?

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.

What is protein folding?

During a protein's development, folding occurs so the protein is shaped into its correct, 3-dimensional structure.3

What is 20-nanometer (nm) filtration?

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 centimeter.2

What is half-life?

Half-life is how long it takes for the amount of drug in the body to be reduced by one half.

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.

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®.

For additional important risk and use information, please see full Prescribing Information.

References: 1. U.S. National Library of Medicine. Genetics Home Reference: Conditions: Hemophilia. https://ghr.nlm.nih.gov/condition/hemophilia. Accessed March 24, 2016. 2. KOVALTRY® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016. 3. Cooper G, Hausman R. The Cell: A Molecular Approach. 4th ed. Sunderland, MA: Sinauer Associates; 2007.

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 02/2018