Pronunciation: Reh-be-nine
Generic name: glycopegylated coagulation factor IX (recombinant)
Dosage form: powder for intravenous injection
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 16, 2024.

What is Rebinyn?

Rebinyn (glycopegylated coagulation factor IX [recombinant]) is an injectable, long-lasting, human blood coagulation factor that may be used to manage active bleeding, bleeding during surgery, and to reduce the frequency of bleeding episodes in adults and children with hemophilia B.

Hemophilia B (also called congenital Factor IX deficiency or Christmas disease) is an inherited bleeding disorder characterized by deficient or defective factor IX, that prevents blood from clotting normally. Rebinyn works by temporarily replacing the missing coagulation Factor IX needed for effective blood clotting (hemostasis). It has been conjugated with a polyethylene glycol molecule (glycopegylated) which slows down its removal from the blood and extends how long it lasts in the body.

Rebinyn was FDA-approved on May 31, 2017.

What are the side effects of Rebinyn?

Rebinyn can cause serious side effects (see warnings below).

The most common side effects of Rebinyn affecting 1% or more people receiving it are itching, injection site reactions, rash, hypersensitivity, and anaphylactic reactions.

Animal data has reported an accumulation of polyethylene glycol (PEG) in certain organs after repeated dosing but the significance of this for humans is unknown.

These are not the only side effects possible with Rebinyn. To learn more, talk to your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or does not go away. You may report side effects to Novo Nordisk Inc. at 1-877-668-6777 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Related/similar drugs

NovoSeven RT, Hemgenix, BeneFix, Idelvion, coagulation factor ix, Alprolix, Ixinity

Warnings and serious effects

Do not receive Rebinyn if you

• have had life-threatening hypersensitivity reactions to Rebinyn, coagulation factor IX [recombinant], or any of the inactive ingredients in the vial or diluent.
• are allergic to hamster proteins.

Allergic and hypersensitivity reactions have been reported with Rebinyn. Patients may develop hypersensitivity to hamster (CHO) protein as Rebinyn contains trace amounts. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headedness, dizziness, nausea, or a decrease in blood pressure.

Your body can make antibodies, called inhibitors, against Factor IX, which may stop Rebinyn from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.

Rebinyn may increase the risk of forming abnormal 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.

Nephrotic syndrome (a kidney disorder that causes your body to pass too much protein in your urine) has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of allergic reactions to factor IX.

Rebinyn may affect the results of some laboratory tests that use a certain type of activated partial thromboplastin time (aPTT) reagent.

Before taking

Before receiving Rebinyn, you should tell your healthcare provider if you:

• have or had any medical problems
• take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies
• have had an allergic reaction to any Factor IX product before using Rebinyn
• have any allergies, including allergies to hamster proteins
• have been told that you have inhibitors to Factor IX (because Rebinyn may not work for you)
• are pregnant or planning to become pregnant
• are breastfeeding.

Pregnancy

It is not known if Rebinyn can harm your unborn baby. Talk to your healthcare provider about the risks involved with receiving Rebinyn if you are pregnant.

Breastfeeding

It is not known if Rebinyn passes into your milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Rebinyn.

How is Rebinyn administered?

Rebinyn is administered by an intravenous (into a vein) infusion, directly into the bloodstream. It is usually administered by a healthcare provider initially, but people can be taught how to self-administer it themselves, or a caregiver can be taught how to administer it to a person with hemophilia B.

• Do not attempt to administer Rebinyn yourself unless you have been shown how to do so by a healthcare provider.
• Follow the step-by-step instructions provided in the product information.
• Rebinyn needs to be diluted before use. Once diluted, it should be administered immediately or within 4 hours of mixing.

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

• You may need to have blood tests done after administering Rebinyn 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 administering Rebinyn.

It is a good idea to record the lot number from the Rebinyn vial label every time you use Rebinyn. You can use the peel-off label found on the vial to record the lot number.

Rebinyn may be used:

• To control and prevent bleeding episodes
• During surgery
• To reduce the number of bleeding episodes when used regularly (prophylaxis).

The frequency of administration depends on what Rebinyn is being used to treat, but it is usually given every 7 days to prevent and control bleeding episodes.

Do not use Rebinyn for a condition for which it is not prescribed or share it with other people, even if they have the same symptoms that you have.

What are the dosage strengths of Rebinyn?

Rebinyn comes in four different dosage strengths which are printed on the vial label:

• 500 IU (red)
• 1000 IU (green)
• 2000 IU (yellow)
• 3000 IU (dark grey).

Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.

What happens if I miss a dose?

If you forget a dose, infuse the missed dose when you discover the mistake. Do not infuse a double dose to make up for a forgotten dose. Proceed with the next infusions as scheduled and speak to your healthcare provider if you have any questions or concerns.

Do not stop using Rebinyn without consulting your healthcare provider.

What happens if I overdose?

Always take Rebinyn exactly as your healthcare provider has told you. You should check with your healthcare provider if you are not sure. If you infuse more Rebinyn than recommended, tell your healthcare provider as soon as possible.

What other drugs will affect Rebinyn?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rebinyn may affect the way other medicines work. Especially tell your healthcare provider if you take other medications that:

• affect the way your blood clots, such as carfilzomib
• affect other coagulation factors, such as efgartigimod alfa or rozanolixizumab
• also contain PEG, such as pegloticase or pegvaliase.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Store the unmixed vial of Rebinyn in its original carton to protect it from light. It can be stored in the refrigerator at 36°F-46°F (2°C-8°C) for up to 24 months from the date of manufacture until the expiration date stated on the label.

It may also be stored at room temperature not to exceed 86°F (30°C) for up to 6 months within the 24 months. Record the date when the product was removed from the refrigerator in the space provided on the outer carton. The total time of storage at room temperature should not exceed 6 months. Do not return the product to the refrigerator. Do not freeze.

Do not use it after the expiration date printed on the label.

Once the dry product has been mixed with the diluent (reconstituted) it must be used within 4 hours. Do not refrigerate, keep at room temperature.

Discard any unused reconstituted Rebinyn.

Rebinyn ingredients

Active: purified recombinant human Factor IX (rFIX) with a 40 kilodalton (kDa) polyethylene-glycol (PEG) conjugated to the protein.

Inactive: sodium chloride, 2.34 mg; histidine, 3.10 mg; sucrose, 10 mg; mannitol, 25 mg; polysorbate 80, 0.05 mg.

Contains no preservatives.

Available in the following unit strengths: 500, 1000, 2000, or 3000 IU.

Manufacturer

Novo Nordisk Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer