Important Safety Information  |  Prescribing Information

Used to treat, prevent, or reduce the number of bleeding episodes in people with hemophilia B. See full indication below.

 

[Dear] [Hi] [Hello] [patient firstname] [patient lastname],

As your [Hemophilia Community Liaison (HCL)] [HCL], I’m excited to share [news] [information] about once-weekly prophylaxis with Rebinyn^®.

Check out the [update] [info] below, and please feel free to contact me with any questions or to discuss this information—I’d be happy to talk through it with you.

[Warm regards] [Sincerely] [Yours],

[HCL firstname] [HCL lastname]

[HCL contact info]

ONCE-WEEKLY PROPHYLAXIS

Be ready for the unexpected

Once-weekly Rebinyn^® helps you keep Factor 9 levels higher for longer.^a

^aRebinyn^® achieved and maintained higher factor levels than recombinant Factor 9 based upon a phase 1 study comparing 25, 50, and 100 IU/kg single doses of Rebinyn^® to a 50 IU/kg single dose of standard half-life rFIX in 7 adults and a 50 IU/kg dose of plasma-derived Factor 9 in 8 adults. For Rebinyn^®, estimated average Factor 9 activity is adjusted to a dose of 50 IU/kg. Incremental recovery at 30 minutes (IR₃₀) and half-life were higher and longer with Rebinyn^® than recombinant Factor 9 (IR₃₀ 0.0131 vs 0.0068 (IU/mL)/(IU/kg) and half-life 93 vs 19 hours). The clinical relevance of these pharmacokinetic differences is unknown. Incremental recovery is the increase in plasma concentration per IU/kg of factor administered. Half-life is the time it takes for the level of factor in the blood to fall by half (50%).

Simple once-weekly dosing for routine prophylaxis: 40 IU/kg for all ages. Your doctor may adjust your dosing regimen based on your bleeding pattern and physical activity.

Selected Important Safety Information

What is the most important information I need to know about Rebinyn^®?

• 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^®.

Who should not use Rebinyn^®?
Do not use Rebinyn^® if you:

• are allergic to Factor IX or any of the other ingredients of Rebinyn^®.
• are allergic to hamster proteins.

Please click here or scroll below for additional Important Safety Information.

Rebinyn^® helps you achieve high factor levels so you can be ready for the unexpected

Rebinyn^® once-weekly prophylaxis helped previously treated adults spend more time with Factor 9 levels in the non-hemophilia range (greater than 40%).^b In adults:

In adults the half-life^d was 115 hours^e (n=6).

In adolescents the half-life^d was 103 hours^e (n=3); Factor 9 levels after infusion were 83%, and Factor 9 levels at Day 7 were 24% (n=9).^c

^bData 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 (approximately 80% of the week).

^cBased on the mean steady-state post-dose peak levels and pre-dose trough levels 168 hours after administered Rebinyn^® 40 IU/kg once weekly in previously treated patients (20 adult and 9 adolescent patients).

^dHalf-life: Time required for Factor 9 to decline to half its value.

^eBased on analysis using a 1-stage assay in patients (n=6), aged 18 and older, the half-life at steady state was 115 hours following once-weekly (40 IU/kg) dosing; in patients (n=3), aged 13-17, the half-life at steady state was 103 hours. Following single-dose administration (40 IU/kg) in the same patient population, the half-life was 83 hours (adults) and 89 hours (adolescents).

Maintaining factor levels between doses

The World Federation of Hemophilia (WFH)^f says an extended half-life prophylaxis can allow individuals to keep Factor 9 levels in the non-hemophilia range (greater than 40%) for a significant amount of time.

^fWFH offers guidelines that inform shared decision-making between patients, caregivers, and healthcare providers based on data from existing peer-reviewed findings.

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

What is the most important information I need to know about Rebinyn^®?

• 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^®.

Who should not use Rebinyn^®?
Do not use Rebinyn^® if you:

• are allergic to Factor IX or any of the other ingredients of Rebinyn^®.
• are allergic to hamster proteins.

What should I tell my healthcare provider before using Rebinyn^®?
Tell your healthcare provider if you:

• have or have had any medical conditions.
• take any medicines, including non-prescription medicines and dietary supplements.
• are nursing, pregnant, or plan to become pregnant.
• have been told you have inhibitors to Factor IX.

How should I use Rebinyn^®?

• Rebinyn^® is given as an infusion into the vein.
• Call your healthcare provider right away if your bleeding does not stop after taking Rebinyn^®.
• Do not stop using Rebinyn^® without consulting your healthcare provider.

What are the possible side effects of Rebinyn^®?

• Common side effects include infusion site reaction (bruising, bleeding, swelling, pain, or redness), itching, and rash.
• 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.
• 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.
• 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.
• 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.

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.