What Is Rebinyn, Coagulation Factor IX – (Recombinant)?

Rebinyn is a prescription medicine used to treat patients with hemophilia B. It is a recombinant protein, which means it is designed synthetically by humans to mimic the function of naturally occurring clotting factor IX protein in the body. This blood clotting protein helps to prevent excessive blood loss in healthy individuals. 

Rebinyn belongs to the “clotting factors” drug class and is used to stop bleeding by helping the blood clot in patients with hemophilia B. This medication was first approved by the U.S. Food and Drug Administration (FDA) on May 31, 2017, based on the positive results of four completed clinical trials. 

This medication is available in a single-use vial and can only be obtained via a doctor’s prescription. 

What Is Rebinyn Used to Treat?

Rebinyn is indicated to:

• Control active bleeding episodes in hemophilia B patients. 
• Prevent frequency of bleeding episodes in patients with hemophilia B.
• Prevent bleeding during surgery in patients with hemophilia B. 

It is typically prescribed to adults and children with hemophilia B, and cannot be used as immune tolerance therapy in patients with hemophilia B. 

How Does Rebinyn Work?

In patients with hemophilia B, clotting Factor IX is either missing or does not work properly, which causes excessive bleeding in these patients, even with a minor dental injury. 

Rebinyn works to replace the faulty or missing factor IX and helps the blood form a clot at the bleeding site. It has an approximately extended half-life (5 times longer than older coagulation factor Ⅸ drugs such as BeneFix), which means it stays in your blood longer to control bleeding and reduces the number of infusions needed. 

What Are the Available Dosage Forms and Strengths?

Rebinyn is available in lyophilized powder form in a single-dose vial with concentrations (strengths) of 500, 1,000, 2,000, and 3,000 IU per vial. The powder is reconstituted with 4 ml of histidine diluent, which gives the following concentrations per ml:

• 500 IU (125 IU/ml) 
• 1,000 IU (250 IU/ml)
• 2,000 IU (500 IU/ml)
• 3,000 IU (750 IU/ml)

What Is the Usual Dose for Patients With Hemophilia B?

The dose of Rebinyn is adjusted according to the patient’s weight and the type of bleeding or surgery they experienced. 

For Minor-To-Moderate Bleeding, Prevention, or Minor Surgery:

If a patient has minor and moderate bleeding, such as joint bleeds, minor muscular bleeds, or mucosal or subcutaneous bleeds, the recommended dosage of Rebinyn is 40 IU/kg (body weight). 

The recommended dosage for minor surgery, such as skin biopsies and dental procedures, is also 40 IU/kg (body weight). 

For Major Bleeding or Surgical Procedures:

If a patient has major bleeding or a surgical procedure, the recommended dosage is 80 IU/kg (body weight). Moreover, an additional dose of 40 IU/kg (body weight) can be given if required by the patient.

How Rebinyn Is Given

Rebinyn is given by a healthcare provider as an intravenous (IV) infusion (slowly over 1 to 4 minutes) directly into the bloodstream. 

The solution should be administered within 4 hours after reconstituting with the histidine solution.

Common Side Effects

Along with its beneficial effects, Rebinyn does have some side effects associated with its use. Some of the common side effects you may experience are:

• Infusion site reaction, such as bruising, bleeding, swelling, pain, or redness (seen in ≥ 1% of patients during trials)
• Itching (seen in ≥ 1% of patients during trials)
• Rash 
• The presence of factor IX inhibitors

Though it is rare, hypersensitivity or allergic reactions can progress into severe anaphylaxis (including anaphylactic shock). The early signs of allergic reactions, which can progress to anaphylaxis, may include: 

• Angioedema (swelling of the lips, face, tongue, or throat)
• Chest tightness
• Dyspnea (trouble breathing)
• Wheezing 
• Urticaria (hives)
• Pruritus (itching)

If you experience these symptoms, discontinue the intake of Rebinyn and consult your healthcare provider immediately to seek appropriate treatment. 

An allergic reaction can happen due to the presence of factor IX inhibitors. Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.

Rebinyn is a prescription medicine used to treat patients with hemophilia B. It is a recombinant protein, which means it is designed synthetically by humans to mimic the function of naturally occurring clotting factor IX protein in the body. This blood clotting protein helps to prevent excessive blood loss in healthy individuals. 

What Precautions Should You Take While Taking Rebinyn?

Always consult your healthcare provider before taking Rebinyn. Tell your doctor if you:

• Are pregnant or planning to become pregnant
• Are breastfeeding
• Are allergic to any component of Rebinyn recombinant product
• Are allergic to hamster proteins
• Have other medical conditions such as thrombosis, disseminated intravascular coagulation (DIC), and liver disease
• Have undergone surgery
• Are taking any medicines, including non-prescription medicines (herbal medicines) and dietary supplements
• Have tested positive for factor IX inhibitors 

What Drugs Should You Avoid While Taking Rebinyn?

Drugs can affect the way Rebinyn works. Therefore, if you’re taking other medications like carfilzomib, tranexamic acid, aminocaproic acid, or rozanolixizumab, tell your doctor immediately before receiving Rebinyn treatment. 
Interaction of Rebinyn with these drugs can affect the way your blood clots and may affect the working mechanisms of other blood clotting factors. 
 

Storage

Rebinyn vials can be stored at room temperature (up to 86˚F) for up to 6 months.
After reconstitution, it may be stored for up to 4 hours.
Rebinyn vials can also be stored for up to 2 years (24 months), or until the expiration date, in the refrigerator at 36˚F – 46˚F. 
 

Cost

Rebinyn intravenous powder for injection (recombinant) costs around $15 for a supply of one lyophilized powder vial. However, the cost can differ depending on insurance coverage. 
 

Drug Summary

Rebinyn is a medication typically prescribed to patients (adults and children) with hemophilia B. It is administered intravenously and works to control bleeding episodes and prevent bleeding during surgery in hemophilia patients. Common side effects include rash, itching, allergic reactions, and injection site reactions.