Unlocking Self-Potential

Watch How your ADVATE is Made

Ever wonder who made your ADVATE [Antihemophilic Factor (Recombinant)] and how? We went behind the scenes at one of our Shire manufacturing facilities to give you a look at the process.

ADVATE [Antihemophilic Factor (Recombinant)]

Please see indications and important safety information at the end of this video.

Hemophilia A patients like you, know they can depend on ADVATE to help prevent bleeds1, but what you may not know is how much care and attention to detail we put into each little vial. Because at every Shire facility, all around the globe, we know that every vial has a name, every name has a story, and every story has a beginning.

Shire is our new name, but Baxter's Biosciences has been helping patients all over the world for over 60 years. Thanks to you, our proven history of treatment options in hemophilia A is expanding.

Everyone who works in each of our plants is passionate about what they do because they know they're impacting the lives of thousands of patients from the moment they step through the doors.

It's quite remarkable all the people, the processes and the passion that go into creating your personal vial of ADVATE.

We produce over a million vials of hemophilia A treatments through this facility each year and every dose goes through a rigorous process in all three of our main departments: Production, Aseptic Manufacturing and Packaging.

Every vial of ADVATE begins with production, where dozens of dedicated employees work in round the clock shifts to grow cell cultures that produce the factor 8 you need to prevent bleeds1. The factor 8 is then separated from the cells, purified and combined into a protein concentrate1. From there, the product moves into Aseptic Manufacturing, which is an aseptic environment monitored closely to ensure sterility.

There's so much attention to detail here because this is where we formulate ADVATE to the strength of your prescription. We develop 11 potencies here, allowing for a range of single-vial dosing options1. We then load it into vials and freeze-dry to maintain the quality and purity right up until the expiration date on the package.

Once ADVATE is prepared for you, the packaging department vacuum tests every vial for additional quality assurance.

After inspection, it's loaded into the BAXJECT III reconstitution system, which you may recognize, labeled and boxed up for shipment, just like you see it when you open the package.

At Shire, we're dedicated to creating the treatments that can have an impact every day, because we never forget every vial has a name.

The Areas We Explored:


Indications and Detailed Important Risk Information for ADVATE [Antihemophilic Factor (Recombinant)].
See full Prescribing Information.

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

Indications

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 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

You should not use ADVATE if you:

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

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

You should tell your healthcare provider 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.
  • Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

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. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

You can have an allergic reaction to ADVATE.

Call your healthcare provider 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.

Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash.

Tell your healthcare provider 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-1088.

Please see ADVATE full Prescribing Information.