ASH Clinical News ACN_6.8_Full_Issue_web | Page 3

ADVATE has over 15 years of treatment experience in the real world and provides
clinically proven bleed protection* for patients with hemophilia A.1
Proven
clinical record 2
Extensively studied—15 years
with 15 prospective studies 2,3
The most widely used FVIII product,
with 33 billion IUs sold globally 2†
REAL LIFE. REAL BLEED PROTECTION.*
AdvateRealLife.com/HCP
WARNINGS & PRECAUTIONS (continued)
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.
ADVERSE REACTIONS
• Serious adverse reactions seen with ADVATE are
hypersensitivity reactions, including anaphylaxis, and
the development of high-titer inhibitors necessitating
alternative treatments to factor VIII.
• The most common adverse reactions observed in clinical
trials (>5% of subjects) were pyrexia, headache, cough,
nasopharyngitis, arthralgia, vomiting, upper respiratory tract
infection, limb injury, nasal congestion, and diarrhea.
Please see the following page for the Brief Summary of the ADVATE full Prescribing Information.
For Full Prescribing Information, visit www.advatepro.com.
REFERENCES: 1. ADVATE Prescribing Information. 2. Takeda data on fi le. 3. 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.
Copyright © 2020 Takeda Pharmaceutical Company Limited. 300 Shire Way, Lexington, MA 02421. 1-800-828-2088. All rights reserved.
TAKEDA and the TAKEDA logo are trademarks or registered trademarks of Takeda Pharmaceutical Company Limited.
ADVATE is a registered trademark of Baxalta Incorporated, a Takeda company.
US-ADV-0121v1.0 05/20