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.
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 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
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.
Advate. Prescribing information. Baxalta US Inc; 2018.
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
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
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
myPKFiT for healthcare professionals. User manual. Version 3.3. Shire Inc; 2020.
Takeda data on file.
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