Prescription medicine
Coagulation factor ix recombinant and glycopegylated Brand names: Rebinyn
Coagulation factor ix recombinant and glycopegylated (Rebinyn) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the coagulation factor ix recombinant and glycopegylated FDA label on DailyMed (effective August 11, 2022); every coagulation factor ix recombinant and glycopegylated label on DailyMed.
Highlights of the record
FDA label of August 11, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageREBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for:
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes Limitations of Use: REBINYN is not i
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 64 through July 30, 2026
What is coagulation factor ix recombinant and glycopegylated used for?
From the label: indications and usageREBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for:
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes Limitations of Use: REBINYN is not indicated for immune tolerance induction in patients with hemophilia B. […]
Source: FDA drug label (REBINYN), Novo Nordisk, effective August 11, 2022 (SPL set 0ea37235-35fd-410d-b8c4-40ba15fe1294), via openFDA; the full label on DailyMed
What does the patient leaflet for coagulation factor ix recombinant and glycopegylated say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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. You must carefully follow your healthcare provider's instructions regarding the dose and schedule for infusing REBINYN so that your treatment will work best for you.
From the patient leaflet: How should I store REBINYN?Prior to Reconstitution (mixing the dry powder in the vial with the diluent): Store in original package in order to protect from light. Do not freeze REBINYN. REBINYN vials can be stored in the refrigerator (36-46°F [2°C – 8°C]) for up to 24 months until the expiration date, or at room temperature (up to 86°F [30°C]) for a single period not more than 6 months. If you choose to store REBINYN at room temperature: • Note the date that the product is removed from refrigeration on the box. • The total time of storage at room temperature should not be more than 6 months. Do not return the product to the refrigerator. • Do not use after 6 months from this date or the expiration date listed on the vial, whichever is earlier. Do not use this medicine after the expiration date which is on the outer carton and the vial. The expiration date refers to the last day of that month. […]
Source: FDA drug label (REBINYN), Novo Nordisk, effective August 11, 2022 (SPL set 0ea37235-35fd-410d-b8c4-40ba15fe1294), via openFDA; the full label on DailyMed
Is there a generic for coagulation factor ix recombinant and glycopegylated (Rebinyn)?
No generic coagulation factor ix recombinant and glycopegylated is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for coagulation factor ix recombinant and glycopegylated?
The FDA Adverse Event Reporting System holds 64 reports that list coagulation factor ix recombinant and glycopegylated among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 26 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Coagulation factor ix recombinant and glycopegylated side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other