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

Stay Informed Detailed Important Risk Information Prescribing Information Patient & caregiver site

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.

LEARN MORE

^*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

SEE THE DATA

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.

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

Learn More

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.

ADVATE 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.

Click to read Full Prescribing Information.

MYPKFIT FOR ADVATE INTENDED USE

The myPKFiT software is intended for use by licensed healthcare professionals (HCPs) who are familiar with hemophilia care. The myPKFiT software can be used to generate ADVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16 years of age and older and body weight of 45 kg or greater, using that patient’s age and body weight information and local laboratory FVIII one-stage clotting activity measurements of sparse samples collected from that patient.
A minimum of two sparse sampling points are required at the recommended 3-4 hours (± 30 minutes) and at 24-32 hours (±1 hour) post-infusion.
HCPs will also be able to evaluate various prophylaxis dose regimens tailored to an individual patient's needs and treatment plan.
The software output may be used to guide decisions on appropriate ADVATE dose and infusion intervals to maintain FVIII activity levels at or above a user specified minimum FVIII activity level between 1% to 3% above natural baseline for an individual patient in accordance with the FDA-approved dosing recommendations provided in the ADVATE Prescribing Information (PI).
myPKFiT should only be used to evaluate prophylactic dosing regimens for hemophilia A patients treated with ADVATE, as per the ADVATE Prescribing Information (PI).
myPKFiT for ADVATE is not indicated for the treatment of von Willebrand disease. MyPKFiT for ADVATE should not be used for patients who have developed neutralizing antibody (inhibitor) to FVIII products.

myPKFiT for ADVATE is Rx only. For safe and proper use of the myPKFiT software, please refer to the complete instructions for use in the User Manual.

References References

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.

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

What is ADVATE?

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

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?

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

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

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

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