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Questions? Call 855-4ADYNOVATE

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Shire
1200 Lakeside Drive
Bannockburn, IL 60015
(800) 423-2090

For general questions about ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated], reconstitution, product support, or this site, please call the ADYNOVATE Hotline to speak with one of our customer service representatives.

ADYNOVATE Hotline
For general ADYNOVATE information, including product support and requests for educational materials, please call 1-855-4ADYNOVATE (1-855-423-9668) betweeen 9:00 a.m. and 11:00 p.m. (ET).

If you have a clinical question regarding ADYNOVATE, please contact Shire Medical Information.

Medical Information
1-866-4BIOSCI (424-6724)
Monday–Friday 9 am – 5 pm (EST)
medinfo@baxalta.com

Detailed Important Risk Information
Prescribing Information (PI)
ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
Indications

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management
  • Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION


Click here for ADYNOVATE full Prescribing Information.



ADVATE [Antihemophilic Factor (Recombinant)] Important Information
Indications

ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • Control and prevention of bleeding episodes.
  • Perioperative management.
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

ADVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

Neutralizing Antibodies
Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.

Click here for ADVATE full Prescribing Information.