Place your infusion materials on a clean, flat surface.

Check the expiration date and verify the correct potency to be infused.

Allow ADVATE to warm to room temperature.

Wash your hands. Use of exam gloves is optional, if infusing yourself at home.

Remove ADVATE with BAXJECT III system from the packaging by peeling away the lid. And set it down on the flat surface with the diluent vial on top. You can identify the diluent vial by the blue stripe.

With one hand holding the ADVATE housing, press down firmly on the diluent vial with the other hand until the system is fully collapsed and the diluent flows down into the ADVATE vial. Swirl gently until the ADVATE is completely dissolved.

The solution should be clear and colorless.

Remove the blue cap.

Take the syringe and push the plunger all the way in.

Screw the syringe into the system and turn the system over so that the diluent vial with the blue stripe is on the bottom and the vial containing ADVATE solution is on top. Slowly draw the solution into the syringe. Be careful not to inject air into the system.

It is acceptable for a small amount of liquid to remain in the vial.

Once you've collected the reconstituted ADVATE you are ready to continue with the infusion process.

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

What is ADVATE?

• ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia).
• ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A. Your healthcare provider (HCP) may give you ADVATE when you have surgery.
• ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).

ADVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

Who should not use ADVATE?

Do not use ADVATE if you:

• Are allergic to mice or hamsters.
• Are allergic to any ingredients in ADVATE.

Tell your HCP if you are pregnant or breastfeeding because ADVATE may not be right for you.

What should I tell my HCP before using ADVATE?

Tell your HCP if you:

• Have or have had any medical problems.
• Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
• Have any allergies, including allergies to mice or hamsters.
• Are breastfeeding. It is not known if ADVATE passes into your milk and if it can harm your baby.
• Are or become pregnant. It is not known if ADVATE may harm your unborn baby.
• Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

What important information do I need to know about ADVATE?

• You can have an allergic reaction to ADVATE. Call your HCP right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
• Do not attempt to infuse yourself with ADVATE unless you have been taught by your HCP or hemophilia center.

What else should I know about ADVATE and Hemophilia A?

• Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

What are possible side effects of ADVATE?

• Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, unusual taste, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash. Tell your HCP about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

For additional safety information, click here for Prescribing Information and discuss with your HCP.

The following instructions will guide you through recovering ADVATE with BAXJECT III if the initial reconstitution procedure does not work.

Reasons why there might be a diluent transfer difficulty:

• If you activated the ADVATE with the BAXJECT III system upside down (blue stripe at bottom)
• If the system is tilted while diluent is transferring
• If the blue cap located on the side of the system is removed before activating the system
• If you have injected air into the system in error
• If you did not press down hard enough to activate

First, make sure ADVATE with BAXJECT III system is in the correct orientation, on a clean, flat surface with the diluent vial on top. The diluent vial has the blue stripe.

Also, on a clean, flat surface, make sure the product and diluent vials are fully activated and pressed into the white plastic housing.

• Remove the blue cap on the side.
• Press the plunger to expel any air from the syringe.
• Screw the syringe into the system.
• Pull the plunger back slowly to withdraw air from the vials.

This will force the diluent into the ADVATE vial. Do not tilt the system until the diluent transfer is complete.

• Disconnect the syringe from the system.
• Swirl gently until the ADVATE is completely dissolved.
• The solution should be clear and colorless.

Again, press the plunger to expel any air from the syringe.

Reconnect the syringe to the side of the system, and turn the system over so that the diluent vial with the blue stripe is on the bottom.

Slowly draw the solution into the syringe. Be careful not to inject air into the system.

It is acceptable for a small amount of liquid to remain in the vial

Once you've collected the reconstituted ADVATE, you are ready to continue with the infusion process.

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

What is ADVATE?

• ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia).
• ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A. Your healthcare provider (HCP) may give you ADVATE when you have surgery.
• ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).

ADVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

Who should not use ADVATE?

Do not use ADVATE if you:

• Are allergic to mice or hamsters.
• Are allergic to any ingredients in ADVATE.

Tell your HCP if you are pregnant or breastfeeding because ADVATE may not be right for you.

What should I tell my HCP before using ADVATE?

Tell your HCP if you:

• Have or have had any medical problems.
• Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
• Have any allergies, including allergies to mice or hamsters.
• Are breastfeeding. It is not known if ADVATE passes into your milk and if it can harm your baby.
• Are or become pregnant. It is not known if ADVATE may harm your unborn baby.
• Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

What important information do I need to know about ADVATE?

• You can have an allergic reaction to ADVATE. Call your HCP right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
• Do not attempt to infuse yourself with ADVATE unless you have been taught by your HCP or hemophilia center.

What else should I know about ADVATE and Hemophilia A?

• Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

What are possible side effects of ADVATE?

• Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, unusual taste, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash. Tell your HCP about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

For additional safety information, click here for Prescribing Information and discuss with your HCP.