1 YEAR OF REAL-WORLD EXPERIENCE
DETAILED IMPORTANT RISK INFORMATION CONTRAINDICATIONS
WARNINGS & PRECAUTIONS
ADVERSE REACTIONS
1 YEAR OF REAL-WORLD EXPERIENCE
PROVEN PROPHYLAXIS + SIMPLE , TWICE-WEEKLY DOSING SCHEDULE = moments
THEIR WAY
ADYNOVATE [ Antihemophilic Factor ( Recombinant ), PEGylated ] Important Information
Indication
ADYNOVATE , Antihemophilic Factor ( Recombinant ), PEGylated , is a human antihemophilic factor indicated in adolescent and adult patients ( 12 years and older ) with hemophilia A ( congenital factor VIII deficiency ) for :
• On-demand treatment and control of bleeding episodes
• Routine prophylaxis to reduce the frequency of bleeding episodes
ADYNOVATE is not indicated for the treatment of von Willebrand disease .
DETAILED IMPORTANT RISK INFORMATION CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE , to the parent molecule ( ADVATE [ Antihemophilic Factor ( Recombinant )]), mouse or hamster protein , or excipients of ADYNOVATE ( e . g . Tris , mannitol , trehalose , glutathione , and / or polysorbate 80 ).
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions are possible with ADYNOVATE . Allergic-type hypersensitivity reactions , including anaphylaxis , have been reported with other recombinant antihemophilic factor VIII products , including the parent molecule , ADVATE . Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema , chest tightness , dyspnea , wheezing , urticaria , and pruritus . Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur .
Neutralizing Antibodies
Formation of neutralizing antibodies ( inhibitors ) to factor VIII can occur following administration of ADYNOVATE . Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests . Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected , or if bleeding is not controlled with expected dose .
ADVERSE REACTIONS
Common adverse reactions ( ≥1 % of subjects ) reported in the clinical studies were headache and nausea .
Please see the ADYNOVATE Brief Summary of Prescribing Information on the following page .
© 2016 Shire US Inc ., Lexington , MA 02421 . All rights reserved . 1-800-828-2088 . SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates . ADYNOVATE is a trademark or registered trademark of Baxalta Incorporated , a wholly owned , indirect subsidiary of Shire plc . S17736 11 / 16