ASH Clinical News December 2016 | Page 55

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