Helixate FS (clotting factor) is a naturally occurring protein in the blood. People with hemophilia A have a deficiency in clotting factor VIII. Recombinant this medicine replaces clotting factor VIII in the blood.

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

Recombinant Helixate FS can help prevent joint damage in children who have hemophilia A and no prior joint damage.

Recombinant Helixate FS is not for use in treating von Willebrand disease.

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

Recombinant Helixate FS may also be used for purposes not listed in this medication guide.

Carefully follow all instructions about how to mix and store Helixate FS. Different brands of recombinant Helixate FS may have different storage instructions.

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

Your doctor will perform a blood test to make sure recombinant Helixate FS 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 Helixate FS 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 Helixate FS 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 Helixate FS 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 Helixate FS, making it less effective. Call your doctor if Helixate FS 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 Helixate FS 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 Helixate FS 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 Helixate FS 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.

You should not use this medicine if you have ever had a severe allergic reaction to Helixate FS, 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.

Since recombinant Helixate FS is used when needed, you may not be on a routine dosing schedule. However, you may need to use the medicine for several days in a row to control a bleeding episode. Keep using the medicine as directed and tell your doctor if your bleeding continues.

Use any missed dose as soon as you remember. Do not use two doses at one time.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

Helixate FS may cause serious side effects. Call your doctor at once if you have:

• increased bleeding episodes;

• any bleeding that will not stop;

• chest pain; or

• a light-headed feeling, like you might pass out.

Common side effects of Helixate FS 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.

Other drugs may affect recombinant Helixate FS, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.