Notice Regarding BAXJECT II Reconstitution Devices Packaged with RIXUBIS.

Support for your patients

Takeda has a variety of resources to help patients who have been prescribed RIXUBIS®, including information, guidance, and resources regarding their treatment.

Image of open box RIXUBIS offers a free trial program.

FREEDOM OF CHOICE

Your patients may be eligible to receive 4 free doses of RIXUBIS®. This Free Trial Program is for new RIXUBIS patients only. Participants must receive consultation and approval from a healthcare provider.

Download registration form
Takeda Patient Support logo.

Welcome to Takeda Patient Support
—support specialists your patient can count on

When you prescribe RIXUBIS [Coagulation Factor IX (Recombinant)] for your patient, Takeda Patient Support is here for them. Our support specialists can address your patient’s questions and concerns and help get them the information they need.

For on boarding, access, and reimbursement assistance, our services include:

  • Benefits investigation
    to help determine your patient's insurance benefits and eligibility for certain services.
  • Prior authorization (PA), reauthorization, and appeals information.
  • Information about financial assistance options
    for your patient, if they’re eligible.

Our additional services include:

  • Specialty pharmacy (or site of care) triage
    and coordination
  • Directing your patient  to community support resources
Your Patient Can Enroll by
Visiting our convenient online enrollment portal
Click HERE

Need assistance?
Our support specialists are never more than a tap or a call away—
1-888-229-8379
Monday through Friday,
8 am to 8 pm ET.,
Or Click HERE to learn more.

If your patients are commercially insured and eligible, Takeda Patient Support Co-Pay Assistance Program may cover 100% of eligible out-of-pocket costs related to their prescribed Takeda hematology treatment for which there is a co-pay.* Co-pay costs may include expenses such as deductibles and coinsurances, up to the program maximum.

WANT TO CONNECT?

Our support specialists are never more than a tap or a call away—1-888-229-8379, Monday through Friday, 8 am to 8 pm ET.

Your Patient can join Takeda Patient Support in a few simple steps by clicking HERE.

*IMPORTANT NOTICE: Takeda's Co-pay Assistance Program ("the Program") provides financial support for commercially insured patients who qualify for the Program. Participation in the Program and provision of financial support is subject to all Program terms and conditions, including but not limited to eligibility requirements, the Program maximum benefit per claim and the annual calendar year Program maximum ("Annual Program Maximum"). The Annual Program Maximum for your prescribed Takeda product can be found by visiting Click HERE.

By enrolling in the Program, you agree that the Program is intended solely for the benefit of you—not health plans and/or their partners. Further, you agree to comply with all applicable requirements of your health plan. The Program cannot be used if the patient is a beneficiary of, or any part of the prescription is covered by: 1) any federal, state, or government-funded healthcare program (Medicare, Medicare Advantage, Medicaid, TRICARE, etc.), including a state pharmaceutical assistance program (the Federal Employees Health Benefit (FEHB) Program is not a government-funded healthcare program for the purpose of this offer), 2) the Medicare Prescription Drug Program (Part D), or if the patient is currently in the coverage gap, or 3) insurance that is paying the entire cost of the prescription. 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.

Some health plans have established programs referred to as 'co-pay maximizer' programs. A co-pay maximizer program is one in which the amount of a patient's out-of-pocket costs is adjusted to reflect the availability of support offered by a manufacturer's co-pay assistance program. If you are enrolled in a co-pay maximizer program, your Annual Program Maximum may vary over time to ensure the program funds are used for your benefit (for the benefit of the patient). Takeda also reserves the right to reduce or eliminate the co-pay assistance available to patients enrolled in an insurance plan that utilizes a co-pay maximizer program.

If you learn your health plan has implemented a co-pay maximizer program, you agree to notify the Program immediately 1-888-229-8379. It may be possible that you are unaware whether you are subject to a co-pay maximizer program when you enroll or re-enroll in the Program. Takeda will monitor program utilization data and reserves the right to discontinue assistance under the Program at any time if Takeda determines that you are subject to a co-pay maximizer, or similar program.

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 1-888-229-8379. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law.

This Program offer is not transferable and is limited to one offer per person and may not be combined with any other coupon, discount, prescription savings card, rebate, free trial, patient assistance, co-pay maximizer, alternative funding program, co-pay accumulator, or other offer, including those from third parties and companies that help insurers or health plan manage costs. Not valid if reproduced.

By utilizing the Program, you hereby accept and agree to abide by these terms and conditions. Any individual or entity who enrolls or assists in the enrollment of a patient in the Program represents that the patient meets the eligibility criteria and other requirements described herein. You must meet the Program eligibility requirements every time you use the Program. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice, and other terms and conditions may apply.

Patient counseling information

Please go over the information below with your patients before starting them on

Please go over the information below with your patients before starting them on RIXUBIS. This does not include all the important information about RIXUBIS; see the RIXUBIS full Prescribing Information for the full details.

See FDA-approved Patient Labeling (Patient Information and Instructions for Use)
  • Advise patients to report any adverse reactions or problems following RIXUBIS administration to their physician or healthcare provider
  • Inform patients of the early signs of hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, and hypotension) and anaphylaxis.Instruct patients to discontinue use of the product and contact their physician if these symptoms occur
  • Advise patients to contact their physician or treatment facility for further treatment and/or assessment if they experience a lack of a clinical response to factor IX replacement therapy, as in some cases this may be a manifestation of an inhibitor
  • Ask patients to follow the specific preparation and administration procedures provided by their physician
  • Inform patients to follow the recommendations in the FDA-approved patient labeling
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What is RIXUBIS?1

RIXUBIS is a medicine used to replace clotting factor (Factor IX) that is missing in people with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas

RIXUBIS is a medicine used to replace clotting factor (Factor IX) that is missing in people with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease. Hemophilia B is an inherited bleeding disorder that prevents blood from clotting normally.

RIXUBIS is used to prevent and control bleeding in people with hemophilia B. Your healthcare provider may give you RIXUBIS when you have surgery. RIXUBIS can reduce the number of bleeding episodes when used regularly (prophylaxis).

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Who should not use RIXUBIS?1

You should not use RIXUBIS if you:

You should not use RIXUBIS if you:

  • Are allergic to hamsters
  • Are allergic to any ingredients in RIXUBIS

Tell your healthcare provider if you are pregnant or breastfeeding because RIXUBIS may not be right for you.

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What should you tell your doctor before using RIXUBIS?1

You should tell your healthcare provider if you:

You should tell your healthcare provider if you:

  • Have or have had any medical problems
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies
  • Have any allergies, including allergies to hamsters
  • Are breastfeeding. It is not known if RIXUBIS passes into your milk and if it can harm your baby
  • Are pregnant or planning to become pregnant. It is not known if RIXUBIS may harm your unborn baby
  • Have been told that you have inhibitors to factor IX (because RIXUBIS may not work for you)
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How should you infuse RIXUBIS?1

RIXUBIS is given directly into the bloodstream.
RIXUBIS should be administered as ordered by your healthcare provider. You should

RIXUBIS is given directly into the bloodstream.

RIXUBIS should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with hemophilia B learn to infuse RIXUBIS by themselves or with the help of a family member.

Your healthcare provider will tell you how much RIXUBIS to use based on your weight, the severity of your hemophilia B, and where you are bleeding.

You may have to have blood tests done after getting RIXUBIS to be sure that your blood level of factor IX is high enough to clot your blood.

Call your healthcare provider right away if your bleeding does not stop after taking RIXUBIS.

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What are the possible side effects of RIXUBIS?1

Allergic reactions may occur with RIXUBIS. Call your doctor or get emergency treatment right away if you get a rash or hives, itching, tightness of the throat, chest pain or tightness,

Allergic reactions may occur with RIXUBIS. Call your doctor or get emergency treatment right away if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting. Some common side effects of RIXUBIS were unusual taste in the mouth and limb pain. Tell your healthcare provider about any side effects that bother you or do not go away. These are not all the side effects possible with RIXUBIS. You can ask your healthcare provider for information that is written for healthcare professionals.

Your body may form inhibitors to factor IX. An inhibitor is part of the body's defense system. If you form inhibitors, it may stop RIXUBIS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor IX.

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What are the RIXUBIS dosage strengths?1

RIXUBIS comes in five different dosage strengths: 250 International Units (IU), 500 IU, 1000 IU, 2000 IU, and 3000 IU. The actual strength will be imprinted on the label and on

RIXUBIS comes in five different dosage strengths: 250 International Units (IU), 500 IU, 1000 IU, 2000 IU, and 3000 IU. The actual strength will be imprinted on the label and on the box. The five different strengths are color coded, as follows:

Graphic depicting 5 color-coded dosage strengths, ranging from 250 IU to 3000 IU.

Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider. Always check the expiration date printed on the box. Do not use the product after the expiration date printed on the box.

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How should you store RIXUBIS?1

Store at refrigerated temperature [2°C to 8°C (36°F to 46°F)] or room temperature [not to exceed 30°C (86°F)] for up to 36 months. Do not freeze.
  • Store at refrigerated temperature [2°C to 8°C (36°F to 46°F)] or room temperature [not to exceed 30°C (86°F)] for up to 36 months. Do not freeze
  • Do not use after the expiration date printed on the carton or vial
  • Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. Discard any RIXUBIS left in the vial at the end of your infusion

Medicines are sometimes prescribed for purposes other than those listed here. Do not use RIXUBIS for a condition for which it is not prescribed. Do not share RIXUBIS with other people, even if they have the same symptoms that you have.

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Indications

RIXUBIS® [Coagulation Factor IX (Recombinant)] is an antihemophilic factor indicated in adults and children with hemophilia B for:

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

RIXUBIS® [Coagulation Factor IX (Recombinant)] is an antihemophilic factor indicated in adults and children with hemophilia B for...

Selected Important Risk Information

CONTRAINDICATIONS

RIXUBIS is contraindicated in patients who have:

RIXUBIS is contraindicated in patients who have...

  • Known hypersensitivity to RIXUBIS or its excipients including hamster protein
  • Disseminated Intravascular Coagulation (DIC)
  • Signs of fibrinolysis