RIXUBIS® (Coagulation Factor IX [Recombinant])

RIXUBIS® is a brand-name medication that contains the active ingredient coagulation factor IX (recombinant). It is primarily used for the treatment and prevention of bleeding in individuals with hemophilia B, a hereditary bleeding disorder caused by a deficiency of clotting factor IX. RIXUBIS® is a recombinant form of coagulation factor IX, which is essential for blood clotting. It is used to replace the missing or deficient factor IX in individuals with hemophilia B, reducing the risk of bleeding episodes and assisting in clot formation.

Indications and Uses

RIXUBIS® is indicated for the following purposes:

• Treatment and control of bleeding in individuals with hemophilia B.

• Perioperative management of bleeding in individuals with hemophilia B.

• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in individuals with hemophilia B.

Dosage and Administration

The dosage of RIXUBIS® is determined by a healthcare provider based on the patient's specific condition and the severity of the bleeding episode. The medication is administered by intravenous (IV) injection. The dose and frequency are individualized to the patient's needs and the response to treatment.

Contraindications

RIXUBIS® should not be used in individuals with known hypersensitivity to coagulation factor IX (recombinant) or any of its components. It is essential to discuss any allergies or potential reactions with a healthcare provider.

Adverse Effects and Side Effects

Common side effects of RIXUBIS® may include:

• Formation of inhibitors to factor IX.

• Allergic reactions.

• Headache.

• Dizziness.

• Nausea.

Serious side effects are rare but may include:

• Anaphylactic reactions (severe allergic reactions).

• Thrombosis (formation of blood clots).

• Transmission of viral infections (rare due to the manufacturing process).

It is crucial to report any severe or unusual side effects to your healthcare provider.

Storage and Shelf Life

Store RIXUBIS® at 2-8°C (36-46°F) in the original carton to protect it from light. Do not use RIXUBIS® after the expiration date.

Packaging and Presentation

RIXUBIS® is available as a lyophilized powder in single-use vials for reconstitution.

Regulatory Information

RIXUBIS® is subject to regulation by health authorities to ensure its safety and efficacy. It is essential to use this medication as directed by a healthcare professional and in accordance with local regulations.

References

Always consult with your healthcare provider and refer to the official prescribing information and product labeling for the most up-to-date and comprehensive information on RIXUBIS®. Your healthcare provider will guide you in the proper use of this medication, monitor your progress, and tailor the treatment to your specific medical condition.