IMPORTANT: Contact your doctor or local hemophilia Treatment Center if you experience any problems with this procedure. These instructions are intended only as a visual aid for those patients who have been instructed by their doctor or hemophilia center on the proper way to self-infuse the product.
Do not attempt to self-infuse unless you have been taught how by your doctor or hemophilia center.
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1. In a quiet place, prepare a clean flat surface and gather all the materials you will need for the infusion. Check the expiration date, and let the vial with the ADVATE concentrate and the Sterile Water for Injection, USP (diluent) warm up to room temperature. Wash your hands and put on clean exam gloves. If infusing yourself at home, the use of gloves is optional.
2. Remove caps from the ADVATE concentrate and diluent vials to expose the centers of the rubber stoppers.
3. Disinfect the stoppers with an alcohol swab (or other suitable solution suggested by your doctor or hemophilia center) by rubbing the stoppers firmly for several seconds, and allow to
dry prior to use. Place the vials on a flat surface.
4. Open the BAXJECT II device package by peeling away the lid, without touching the inside of the package. Do not remove the BAXJECT II device from the package.
5. Turn the package with the BAXJECT II device upside down, and place it over the top of the diluent vial. Fully insert the clear plastic spike of the device into the center of the diluent vial’s stopper by pushing straight down. Grip the package at its edge and lift it off the device. Be careful not to touch the white plastic spike. Do not remove the blue cap from the BAXJECT II device.
The diluent vial now has the BAXJECT II device connected to it and is ready to be connected to the ADVATE vial.
6. To connect the diluent vial to the ADVATE vial, turn the diluent vial over and place it on top of the vial containing ADVATE concentrate. Fully insert the white plastic spike into the ADVATE vial’s stopper by pushing straight down. Diluent will flow into the ADVATE vial. This should be done right away to keep the liquid free of germs.
7. Swirl the connected vials gently and continuously until the ADVATE is completely dissolved. Do not shake. The ADVATE solution should look clear and colorless. If not, do not use it and notify Baxter immediately.
8. Take off the blue cap from the BAXJECT II device and connect the syringe. 
9. Turn over the connected vials so that the ADVATE vial is on top. Draw the ADVATE solution into the syringe by pulling back the plunger slowly. Disconnect the syringe from the vials. Attach the infusion needle to the syringe using a winged (butterfly) infusion set, if available. Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of
If you are using more than one vial of ADVATE, the contents of more than one vial may be drawn into the same syringe. However, you will need a separate diluent and
BAXJECT II device to mix each additional vial of ADVATE.
10. Apply a tourniquet, and get the injection site ready by wiping the skin well with an alcohol swab (or other suitable solution suggested by your doctor or hemophilia center).
11. Insert the needle into the vein, and remove the tourniquet. Slowly infuse the ADVATE. Do not infuse any faster than 10 mL per minute.12. Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.
Do not recap the needle.Place it with the used syringe in a hard-walled
Sharps container for proper disposal.
13. Remove the peel-off label from the ADVATE vial and place it in your logbook. Clean any spilled blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap and water, or any household disinfecting solution.
Indications:
ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] is indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes and for perioperative management of patients with hemophilia A.
ADVATE is not indicated for the treatment of von Willebrand’s disease.
Important Safety Information:
Let your doctor know if you have had any previous allergic reactions to other factor VIII products or mouse or hamster proteins.
The most common related adverse reactions observed during the ADVATE clinical studies include: strange taste in mouth, headache, dizziness, and redness in the face.
There is a possibility that you can have an allergic reaction to ADVATE. Symptoms of an allergic reaction may include rash, hives, itching, tightness in throat or chest, difficulty breathing, feeling dizzy or light-headed, or a weak pulse. If you experience any of these symptoms, stop the infusion immediately and promptly contact your doctor.
Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of factor VIII therapy.
