Blog Archive

Sunday, July 31, 2016

Ever wonder? Creating a factor product

In this week’s blog we’re highlighting a short video that shows an inside look at the process that goes in to making ADVATE [Antihemophilic Factor (Recombinant)], a treatment option for hemophilia A. As always, please stay informed about all treatment options and proactively discuss with your physician what may be right for you.

Over its 12 year history as an available treatment option for hemophilia A, there have been more than 24 billion units* of ADVATE distributed worldwide!1,2 Have you ever wondered who made all those units of ADVATE and how? On the ADVATE [Antihemophilic Factor (Recombinant)] website you can get a behind the scenes look at one of the manufacturing facilities to see the process including production, aseptic manufacturing and packaging of the final product. Watch the video here! 
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.
You should not use ADVATE if you:
  • Are allergic to mice or hamsters.
  • Are allergic to any ingredients in ADVATE.
Please see Detailed Important Risk Information below. For full ADVATE Prescribing information, visit www.ADVATE.com.
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. You should not use ADVATE if you:
Are allergic to mice or hamsters.
Are allergic to any ingredients in ADVATE.
Please see Detailed Important Risk Information below (or on page 2). For full ADVATE Prescribing information, visit: insert link,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. You should not use ADVATE if you:
Are allergic to mice or hamsters.
Are allergic to any ingredients in ADVATE.
Please see Detailed Important Risk Information below (or on page 2). For full ADVATE Prescribing information, visit: insert link,Want to learn more?
Watch video stories from those at different points in their journey with hemophilia A

Download helpful resources designed to help you reach your personal goals

Review CoPay program information to see if you’re eligible to receive financial assistance to help cover medication costs

*As of 2016

ADVATE [Antihemophilic Factor (Recombinant)] Important Information

Indication
s
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.
To see the Full Prescribing Information, go to www.ADVATE.com.

References:
1.     Data on file. Westlake Village, CA; Baxalta Healthcare Corporation.
2.     Grillberger L, Kreil TR, Nasr S, Reiter M. Emerging trends in plasma-free manufacturing of recombinant protein therapeutics expressed in mammalian cells. Biotechnol J. 2009;4(2);186-201.

Shire, Baxalta, and Advate are trademarks of Shire plc, its subsidiaries or affiliates.
USBS/34/16-0030
Baxalta, now part of Shire, provided the content of this blog and sponsored its publication.





No comments :

 
Bayer