Support throughout the patient treatment journey

FREEDOM OF CHOICE™ free-trial program

Your patients may be eligible to receive 6 free-trial doses of ADVATE with the FREEDOM OF CHOICE trial program. The free-trial program is for new patients only. Participants must receive consultation and approval from their healthcare provider.

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Hematology Support Center

Takeda’s Hematology Support Center (HSC) is dedicated to helping patients who have been prescribed Takeda hematology products and healthcare providers who have a patient on or ready to start on a Takeda hematology product. HSC offers help with treatment access, as well as educational resources and information for financial assistance programs. Call 1-888-229-8379 Monday–Friday 8:30AM–8:00PM (ET).

Visit Hematologysupport.com

If you have patients that have been prescribed ADVATE, here are a few ways that the HSC can help:

Case Managers

A point of contact who is ready to assist your patients with accessing their treatment

CoPay Assistance

For eligible commercially insured Takeda patients, Takeda's CoPay Assistance Program covers out-of-pocket expenses related to a patient's Takeda Hematology treatment for which there is a co-pay, such as deductibles and coinsurances^†‡§

Patient Access Manager

A Patient Access Manager is available and can provide one-on-one, personalized insurance education and access information

Resources and education

Connecting patients and their caregivers with educational resources–including a Healthcare Educator who can work with them one-on-one if needed

^†Must meet specific program eligibility requirements and terms and conditions. Certain restrictions apply. Not all Takeda hematology products are available for each program.

^‡These programs are not valid for prescriptions reimbursed, in whole or in part by Medicaid, Medicare, Medigap, VA, DoD, TRICARE or any other federal or state healthcare programs, including state pharmaceutical assistance programs, and where prohibited by health insurance provider or by law. Offer good only in the United States. Offer void where prohibited by law, taxed, or restricted. Takeda reserves the right to rescind, revoke or amend each offer at any time without notice.

^§Non-medication expenses, such as ancillary supplies or certain/some administration-related costs, are not eligible.

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.

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