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.

• Bayer HealthCare LLC - Consumer Care

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.

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.

Tell your healthcare provider about all of your medical conditions.

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and nonprescription medicines, such as over-the-counter medicines, supplements, or herbal remedies.

Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

Tell your healthcare provider if you have been told that you have inhibitors to Factor VIII (because Kovaltry may not work for you).

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.

You should always follow the specific instructions for using Kovaltry given by your healthcare provider. If you are unsure of the procedures, please call your healthcare provider before using.

Call your healthcare provider right away if bleeding is not controlled after using Kovaltry. Your healthcare provider will prescribe the dose that you should take.

Your healthcare provider may need to take blood tests from time to time.

Talk to your healthcare provider before traveling. You should plan to bring enough Kovaltry for your treatment during this time.

Reconstitute Kovaltry as directed. Follow the specific infusion instruction leaflet included with the infusion set provided.

Carefully handle Kovaltry. Dispose of all materials, including any leftover reconstituted Kovaltry product, in an appropriate container.

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.

If you receive too much Kovaltry, call your doctor or seek emergency medical treatment.

Do not freeze Kovaltry.

Store Kovaltry at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Kovaltry may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F.

Record the starting date of room temperature storage clearly on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature for 12 months, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light.

Administer reconstituted Kovaltry as soon as possible. If not, store at room temperature for no longer than 3 hours. Throw away any unused Kovaltry after the expiration date. Do not use reconstituted Kovaltry if it is not clear.