Kovaltry (recombinant)

Kovaltry (clotting factor) is a protein that naturally occurs in the blood. People with hemophilia A do not have enough of clotting factor VIII. Recombinant Kovaltry replaces clotting factor VIII in the blood.

Recombinant Kovaltry is used to treat or prevent bleeding episodes in adults and children with hemophilia A. Kovaltry is sometimes given before surgery.

Recombinant Kovaltry can help prevent joint damage in children who have hemophilia A and no previous joint damage.

Recombinant Kovaltry is not for treating von Willebrand disease.

Jivi is not approved for anyone younger than 12 years old.

Recombinant Kovaltry may also be used for reasons not mentioned in this medication guide.

Carefully follow all instructions for mixing and storing Kovaltry. Different brands of recombinant Kovaltry may have different storage instructions.

Your body may develop antibodies to Kovaltry, which can make it less effective. Call your doctor if this medicine appears to be less effective in controlling your bleeding.

You should not use this medicine if you have ever had a severe allergic reaction to Kovaltry, or if you are allergic to mouse or hamster proteins. You should not use the brand Recombinate if you are allergic to beef proteins.

Tell your doctor if you have ever had:

• heart disease;
• a latex allergy; or
• if you have ever been told that you have inhibitors to Factor VIII.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, numbness, tingling; fever, dizziness, nausea; fast heartbeats, chest tightness, wheezing, difficult breathing; pale skin, cold sweat, feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Kovaltry may cause serious side effects. Call your doctor right away if you have:

• increased bleeding episodes;
• any bleeding that will not stop;
• chest pain; or
• a light-headed feeling, like you might faint.

Common side effects of Kovaltry may include:

• nose bleeds;
• nausea, vomiting, diarrhea;
• headache, dizziness;
• muscle or joint pain;
• rash;
• flushing (sudden warmth, redness, or tingly feeling);
• fever, chills;
• cough;
• weakness; or
• pain, swelling, itching, or redness where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Your doctor will perform a blood test to make sure recombinant Kovaltry is the right treatment for your clotting factor deficiency.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your doctor may occasionally change your dose. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Recombinant Kovaltry is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Recombinant Kovaltry must be mixed with a liquid (diluent) before using it. Ask your doctor or pharmacist if you don't understand how to properly mix and store the medicine.

Always wash your hands before preparing and giving your injection.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Recombinant Kovaltry doses are based on weight. Your dose needs may change if you gain or lose weight.

You will need frequent medical tests.

Your body may develop antibodies to Kovaltry, making it less effective. Call your doctor if Kovaltry seems to be less effective in controlling your bleeding.

Get your prescription refilled before you run out of medicine completely. While traveling away from home, be sure you have enough medicine and injection supplies with you.

Store unmixed recombinant Kovaltry in the original package in a refrigerator. Do not freeze. Take the medicine out of the refrigerator and let it reach room temperature before preparing your dose.

You may also store unmixed recombinant Kovaltry at room temperature, but you must not return it to the refrigerator. Some brands of this medicine can be stored at room temperature for only a certain number of months, or until the expiration date (whichever comes first).

Carefully follow all instructions about how to store this medicine. Different brands of recombinant Kovaltry may have different storage instructions.

Do not store in bright light. Do not use past the expiration date on the label.

After mixing the medicine and diluent, keep the mixture at room temperature (not in a refrigerator) and use it within 3 hours.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

In case of emergency, wear or carry medical identification to let others know you have a bleeding or blood-clotting disorder.

Since Kovaltry (recombinant) is used as needed, you might not have a regular dosing schedule. However, you may need to use the medicine for several days in a row to manage a bleeding episode. Continue using the medicine as instructed and inform your doctor if your bleeding does not stop.

Take any missed dose as soon as you remember. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Other drugs may affect Kovaltry (recombinant), including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all your current medicines and any medicine you begin or discontinue.