Support throughout the patient treatment journey

Freedom of choice^™

Free trial program

Your patients may be eligible to receive 8 free-trial doses of ADYNOVATE with the FREEDOM OF CHOICE program. The free trial program is for new patients only. Participants must receive consultation and approval from their healthcare provider.

Download form

Hematology Support Center

Dedicated product support specialists your patient can count on

When you prescribe a Takeda treatment for your patient, Takeda's Hematology Support Center (HSC) is here to provide them dedicated support. At HSC, we know that living with a bleeding disorder looks different for everyone. Whether they've just been diagnosed or have been on treatment for a long time, we tailor our support for your patient by getting to know them. We understand who they are, and we learn what's most important to them—so we can focus on what they specifically need when it comes to their prescribed Takeda therapy. After your patient enrolls in HSC, they'll be connected with a Case Manager (CM). Their CM is the first person who can help when your patient has a question. They will:

Address your patient's questions and concerns
Help determine next steps
Help your patient enroll in Takeda's HSC Co-Pay Assistance Program, if they qualify^†

Along with their CM, other HSC specialists may offer support at any stage of your patient's treatment journey. They are trained to:

Connect your patient with community support resources
Provide your patient with assistance in Spanish, if needed
Work with your office to resolve insurance issues
Help your patient understand what's covered, what's not, and what to do next

If you have questions, call HSC at 1-888-229-8379, Monday through Friday, 8:30 am to 8:00 pm ET.

If English is not your patient's preferred language, we can communicate with them over the phone using a translation service.

^†To be eligible, patients must be enrolled in HSC and have commercial insurance. Other terms and conditions apply. Call HSC for more details.

Visit Hematologysupport.com

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

Case Manager (CM)

When your patient calls the Hematology Support Center, they'll be connected with a Case Manager. The CM will address their questions and concerns and, depending on the situation, help determine next steps. They can also:

Assist with HSC enrollment
Help your patient enroll in Takeda's HSC Co-Pay Assistance Program, if they qualify^‡
Connect your patient with other dedicated HSC specialists as needed

^‡To be eligible, patients must be enrolled in HSC and have commercial insurance. Other terms and conditions apply. Call HSC for more details.

CoPay Assistance

Takeda's HSC Co-Pay Assistance Program can help your patients save on their prescribed Takeda treatment.^§ The program can cover up to 100% of your patient's out-of-pocket co-pay costs, if they're eligible. To be eligible for this program, your patients must:

Be prescribed a Takeda treatment for a Food and Drug Administration (FDA) approved indication.
Have commercial insurance. This includes Health Insurance Marketplace plans.
- Commercial insurance does not include Medicare, Medicaid, Veterans Affairs (VA), or other federal or state health plans
Be enrolled in Takeda's HSC

See below for terms and conditions.

Patient Access Manager (PAMs)

If an insurance issue arises, Patient Access Managers are insurance experts who will help answer questions about your patient's insurance coverage. PAMs can:

Educate your office about prior authorizations, reauthorizations, and appeals
Walk your patient through the insurance process step by step
Help your patient understand what's covered, what's not, and what to do next
Provide information about options that may help your patient cover their Takeda treatment costs

Educational Tools and Resources

Living with a bleeding disorder looks different for everyone. At Takeda's Hematology Support Center we understand that what your patient needs isn't always what every patient needs. Our specialists can help your patient understand their condition and ADYNOVATE. HSC specialists can connect your patient with community support resources and information. If needed, HSC can also provide your patient with assistance in Spanish.

IMPORTANT NOTICE

^§The Hematology Support Center Copay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third party payer, whether public or private. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Copayment assistance under the Program is not transferable. The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify the Program immediately at 888-229-8379. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information

Indications and Limitation of Use

ADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

On-demand treatment and control of bleeding episodes
Perioperative management
Routine prophylaxis to reduce the frequency of bleeding episodes

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

DETAILED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

Prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions: Hypersensitivity reactions are possible with ADYNOVATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, ADVATE. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.

Neutralizing Antibodies: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.

ADVERSE REACTIONS

The most common adverse reactions (≥1% of subjects) reported in the clinical studies were headache, diarrhea, rash, nausea, dizziness and urticaria.

Click here for ADYNOVATE Prescribing Information.
Click here for ADYNOVATE Prescribing Information en Español.

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.

Click here for ADVATE Prescribing Information.
Click here for ADVATE Prescribing Information en Español.

myPKFiT^® for ADYNOVATE 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 ADYNOVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 12 years of age and older and body weight of 29 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 hours (± 30 minutes) and at 48 hours (±2 hours) and/or 72 hours (±2 hours).
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 ADYNOVATE 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 ADYNOVATE Prescribing Information (PI).
myPKFiT should only be used to evaluate prophylactic dosing regimens for hemophilia A patients treated with ADYNOVATE, as per the ADYNOVATE Prescribing Information (PI).
myPKFiT for ADYNOVATE is not indicated for the treatment of von Willebrand disease. MyPKFiT for ADYNOVATE should not be used for patients who have developed neutralizing antibody (inhibitor) to FVIII products.

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

Support throughout the patient treatment journey

IMPORTANT NOTICE

Helpful tools for your patients

Patient retention kit

Support throughout the patient treatment journey

IMPORTANT NOTICE

Helpful tools for your patients

Patient retention kit

Are you a U.S. healthcare professional?

Are you a U.S. healthcare
professional?