For U.S. healthcare professionals only

LIFE

HAPPENS

ADVATE® WILL BE THERE WHEN IT DOES

Indications and Limitations of Use: ADVATE [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A for the control and prevention of bleeding episodes. ADVATE is not indicated for the treatment von Willebrand disease.

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*In clinical trials, ADVATE has demonstrated the ability to help patients prevent bleeding episodes using a prophylaxis regimen.

ADVATE has a legacy of real-world treatment experience and provides clinically proven bleed protection.*1

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SELECTED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS: Patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.

Please see additional detailed important risk information below.

What is ADVATE?

ADVATE is a plasma/albumin-free recombinant factor VIII replacement therapy for patients with hemophilia A.1,3

ADVATE® [Antihemophilic Factor (Recombinant)] has an established safety profile.
ADVATE is indicated for prophylaxis, on-demand, and perioperative use in children and adults with hemophilia A and has an established safety profile.1,4

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

Hypersensitivity reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting. Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Please see additional detailed important risk information below.

myPKFiT® is a PK-guided dosing software and patient app. myPKFiT® is a PK-guided dosing software and patient app.
About myPKFIT®

myPKFiT is the first and only FDA-approved PK dosing software and patient app designed to evaluate prophylactic dosing regimens.5,6

Intended for ADVATE patients 16 years and older with a body weight of 45 kg or greater, myPKFiT enables a personalized approach to prophylaxis treatment.5,6

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IMPORTANT INFORMATION

myPKFiT is not indicated for the treatment of von Willebrand disease and should not be used for patients who have developed neutralizing antibody to FVIII products. myPKFiT is Rx only. For safe and proper use of the myPKFiT software, please refer to the complete instructions for use in the User Manual.

Please see the full intended use statement for myPKFiT below.

Access & Resources

Takeda has a variety of resources to help you and your patient navigate access to ADVATE.

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Resources to help navigate access to ADVATE® [Antihemophilic Factor (Recombinant)]. Resources to help navigate access to ADVATE® [Antihemophilic Factor (Recombinant)].
Learn about personalized dosing for your patients. Learn about personalized dosing for your patients.
Dosing

ADVATE dosing can be personalized for your patients based on their factor VIII replacement therapy needs.1

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  1. Advate. Prescribing information. Baxalta US Inc; 2018.
  2. Khair K, Mazzucconi MG, Parra R, et al. Pattern of bleeding in a large prospective cohort of haemophilia A patients: a three-year follow-up of the AHEAD (Advate in HaEmophilia A outcome Database) study. Haemophilia. 2018;24(1):85-96. doi:10.1111/hae.13361
  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. doi:10.1002/biot.200800241
  4. Shapiro AD, Schoenig-Diesing C, Silvati-Fidell L, Wong WY, Romanov V. Integrated analysis of safety data from 12 clinical interventional studies of plasma- and albumin-free recombinant factor VIII (rAHF-PFM) in haemophilia A. Haemophilia. 2015;21(6):791-798. doi:10.1111/hae.12724
  5. myPKFiT for healthcare professionals. User manual. Version 3.3. Shire Inc; 2020.
  6. Takeda data on file.