ADVATE is indicated for prophylaxis, on-demand, and perioperative use in children and adults with hemophilia A and has an established safety profile.

For U.S. healthcare professionals only

Detailed Important Risk Information Prescribing Information Patient & caregiver site

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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.

*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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ADVATE [Antihemophilic Factor (Recombinant)] Important Information

Indications

ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:

Control and prevention of bleeding episodes.
Perioperative management.
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

ADVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

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

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.

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.

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References References

Advate. Prescribing information. Baxalta US Inc; 2018.
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

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

What is ADVATE?

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

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

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

What is ADVATE?

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

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

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

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