| Spend more time in the non-hemophilia range. |
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| Used to treat, prevent, or reduce the number of bleeding episodes in people with hemophilia B. See full indication below. |
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| Be ready for the unexpected |
| with Rebinyn® once-weekly prophylaxis |
| Don’t let hemophilia B hold you back from life’s adventures. With Rebinyn®, adults and children with hemophilia B can be ready for the unexpected. |
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| Scroll to learn more about Rebinyn®. |
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| Selected Important Safety Information |
| What is the most important information I need to know about Rebinyn®? |
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Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center. Carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing Rebinyn®. |
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| Who should not use Rebinyn®? |
| Do not use Rebinyn® if you: |
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are allergic to Factor IX or any of the other ingredients of Rebinyn®. |
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are allergic to hamster proteins. |
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| Please click here or scroll below for additional Important Safety Information. |
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| Rebinyn® once-weekly can help adults and adolescents achieve Factor 9 levels in the non-hemophilia range.a |
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| Adults and adolescents spend more time in the non-hemophilia range (greater than 40%)a |
| aData represent mean steady-state pharmacokinetic profiles from previously treated adolescent/adult patients with moderate-to-severe hemophilia B (N=9) taking repeated doses of Rebinyn® 40 IU/kg once weekly. Factor 9 levels were within the non-hemophilia range (greater than 40%) for 5.4 days (about 80% of the week). |
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| Children aged 0 to 6: |
Achieved Factor 9 levels of |
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with 15% Factor 9 levels at Day 7b |
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| Children aged 7 to 12: |
Achieved Factor 9 levels of |
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with 19% Factor 9 levels at Day 7b |
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| bMean steady-state pre-dose trough levels and post-dose peak levels across the clinical trials for all previously treated children receiving Rebinyn® 40 IU/kg once weekly. Based on an analysis using a 1-stage assay of previously treated children aged 0 to 12 years old (N=25). Children were stratified into 2 groups; ≤6 years old (N=12) and 7 to 12 years old (N=13). All patients received a fixed dose of 40 IU/kg of Rebinyn® intravenously once weekly for prophylaxis. |
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| Emili and her son Xander, who lives with hemophilia B and uses Rebinyn®. |
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| High factor levels can help protect more moments for little ones. |
| Rebinyn® offers simple, once-weekly dosing that fits into your routine and lifestyle. |
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| Wondering about safety? The safety of Rebinyn® has been established in 5 clinical trials over 13 years. |
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| We’re here to help |
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| Wondering about Rebinyn® or living with hemophilia B? Our Hemophilia Community Liaisons (HCLs) are here to answer your questions and connect you with the resources you need. |
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| Norberto Liriano: FL, South GA, PR, SC |
| Dan Bull: DE, DC, MD, NC, VA |
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| Indications and Usage |
| What is Rebinyn®, Coagulation Factor IX (Recombinant), GlycoPEGylated? |
| Rebinyn® is an injectable medicine used to replace clotting Factor IX that is missing in patients with hemophilia B. Rebinyn® is used to treat, prevent, or reduce the frequency (number) of bleeding episodes in people with hemophilia B. Your healthcare provider may give you Rebinyn® when you have surgery. Rebinyn® is not used for immune tolerance therapy. |
| Important Safety Information (Cont’d) |
| What is the most important information I need to know about Rebinyn®? |
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Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center. Carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing Rebinyn®. |
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| Who should not use Rebinyn®? |
| Do not use Rebinyn® if you: |
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are allergic to Factor IX or any of the other ingredients of Rebinyn®. |
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are allergic to hamster proteins. |
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| What should I tell my healthcare provider before using Rebinyn®? |
| Tell your healthcare provider if you: |
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have or have had any medical conditions. |
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take any medicines, including non-prescription medicines and dietary supplements. |
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are nursing, pregnant, or plan to become pregnant. |
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have been told you have inhibitors to Factor IX. |
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| How should I use Rebinyn®? |
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Rebinyn® is given as an infusion into the vein. |
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Call your healthcare provider right away if your bleeding does not stop after taking Rebinyn®. |
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Do not stop using Rebinyn® without consulting your healthcare provider. |
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| What are the possible side effects of Rebinyn®? |
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Common side effects include infusion site reaction (bruising, bleeding, swelling, pain, or redness), itching, and rash. |
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Your body can also make antibodies called “inhibitors” against Factor IX, including Rebinyn®, which may stop Rebinyn® from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time. |
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Call your healthcare provider right away or get emergency treatment right away if you get, for example, any of the following signs of an allergic reaction: hives, chest tightness, wheezing, difficulty breathing, and/or swelling of the face. |
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You may be at an increased risk of forming blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider if you have chest pain, difficulty breathing, leg tenderness, or swelling. |
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Animals given repeat doses of Rebinyn® showed Polyethylene Glycol (PEG) in certain cells in the brain. The potential human implications of these animal tests are unknown. |
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| Please click here for Prescribing Information. |
Rebinyn® is a prescription medication. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. |
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| Please do not respond to this email. If you would like to contact us, please click here or call 1‑877‑744‑2579. |
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Rebinyn® is a registered trademark of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2022 Novo Nordisk All rights reserved. US22REB00021 October 2022 |
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