RIXUBIS® [Coagulation Factor IX (Recombinant)]

See the RIXUBIS full Prescribing Information for the full details. Please read the information below carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about RIXUBIS. If you have any questions after reading this, ask your healthcare provider.

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 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:

  • 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 I tell my doctor before using RIXUBIS?1

You should tell your healthcare provider if you:

  • Have or have had any medical problems
  • Take any medicines, including prescription and nonprescription 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 I infuse RIXUBIS?1

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, 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.

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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 the box. The five different strengths are color coded, as follows:

250 IU, 500 IU, 1000 IU, 2000 IU, 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 I store RIXUBIS?1

  • Store at refrigerated temperature [C to 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.
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What else should I know about RIXUBIS?1

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.

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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Please see RIXUBIS Indications and Detailed Important Risk Information.

Hemophilia B treatment resources are available to you at Shire

Shire’s CoPay Assistance Program: This program offers CoPay, Coinsurance, and Deductible support to eligible hemophilia patients with commercial insurance, regardless of household income. Enrollment is quick and easy. Call 1-888-229-8379 and answer a few simple questions about yourself and your pharmacy. Visit hematologysupport.com for more information, as well as view full Terms and Conditions for Shire’s CoPay Assistance Program.

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