INTRODUCING
PROVEN PROPHYLAXIS +
SIMPLE,* TWICE-WEEKLY
LY DOSING
LY
DOSING SCHEDULE =
moments THEIR WAY
* ADYNOVATE allows patients to infuse on the same 2 days every week.
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. Allergictype hypersensitivity reactions, including anaphylaxis, have
been reported with other recombinant antihemophilic factor VIII
products, including the parent molecule, ADVATE. Early signs of
Baxalta, Advate, and Adynovate are trademarks of Baxalta Incorporated. USBS/MG159/15-0140
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 following page for the Brief Summary
of ADYNOVATE.
For full Prescribing Information visit www.ADYNOVATEPRO.com.
Reference: 1. ADYNOVATE Prescribing Information.
Westlake Village, CA: Baxalta US Inc.