Kovaltry

Kovaltry is a prescription medication used to treat and control bleeding in adult and children with hemophilia A. It belongs to a group of drugs called clotting factor replacement treatments. These work by replacing clotting factor that is missing in people with hemophilia A.

This medication comes as a dry powder to be mixed into a solution and injected into a vein (IV) by a healthcare provider. 

Common side effects include headache, fever and itchy rash. 

Kovaltry is a prescription medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally. 

Your healthcare provider may give you Kovaltry when you have surgery. Kovaltry can reduce the number of bleeding episodes in adults and children with hemophilia A when used regularly (prophylaxis).

Kovaltry is not used to treat von Willebrand Disease.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Your health care provider will determine the best dose for you based on several factors including your age, body weight, and the reason for using this medication.

Control of bleeding episodes and perioperative management

Required dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal or IU/dL) x reciprocal of expected/observed recovery (e.g., 0.5 for a recovery of 2 IU/dL per IU/kg).

Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg).

Routine prophylaxis

Adults and adolescents: 20-40 IU/kg 2 or 3 times per week.

Children ≤12 years old: 25-50 IU/kg 2 times per week, 3 times per week or every other day.

Hypersensitivity (allergic) reactions, including anaphylaxis, are possible. 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.

You should not use Kovaltry if you:

• are allergic to rodents (like mice and hamsters).
• are allergic to any ingredients in Kovaltry.

Common side effects of Kovaltry include:

• headache
• fever
• 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.

This is not a complete list of Kovaltry side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Tell your doctor if you are pregnant or plan to become pregnant.

There is no available data with Kovaltry use in pregnant women. Animal reproduction studies have not been conducted using Kovaltry. It is not known whether Kovaltry can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Kovaltry should be given to a pregnant woman only if clearly needed.

There is no information regarding the presence of Kovaltry in human milk, the effects on the breastfed infant, or the effects on milk production. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Kovaltry.