Idelvion Coagulation Factor IX (recombinant) Albumin Fusion 0288U Powder Vial (288 Units) **Refrigerated

Idelvion Coagulation Factor IX (recombinant) Albumin is used for the prevention and treatment of bleeding episodes in patients with hemophilia B, a genetic disorder caused by a deficiency of clotting Factor IX. It works by replacing the missing or deficient Factor IX, enabling effective blood clotting and thereby reducing the risk of bleeding complications. Idelvion is also used in surgical settings and as routine prophylaxis to minimize bleeding risk, contributing to improved quality of life for individuals with hemophilia B.

Idelvion Coagulation Factor IX (recombinant) Albumin Fusion, by CSL Behring, is a cutting-edge therapeutic option designed for individuals with Hemophilia B. Presented in a convenient 288-unit powder vial, Idelvion is a long-acting, recombinant coagulation factor IX, fused with albumin to extend its half-life in the circulation. This innovative fusion technology enhances treatment efficacy by enabling prolonged intervals between infusions, while maintaining sustained therapeutic levels of factor IX.

Product Details and Features:

Concentration and Formulation: Each vial contains 288 units of recombinant coagulation factor IX-albumin fusion protein, offering precision dosing for patient-specific needs.
Long-Acting: Engineered to prolong the half-life of factor IX, reducing the frequency of dosing and increasing patient adherence and comfort.
Recombinant Technology: Manufactured using recombinant DNA technology, ensuring high purity, safety, and efficacy.
Albumin Fusion: Utilizes albumin fusion technology to achieve extended circulatory stability, thus optimizing prophylactic and on-demand treatment management.
Indications: Specifically indicated for the prevention and control of bleeding episodes in individuals with Hemophilia B, including perioperative management.

Mechanism of Action:

Idelvion is a coagulation factor IX protein product that works by temporarily replacing the factor IX needed for effective hemostasis in people with Hemophilia B. The albumin fusion element extends the protein's circulatory time, maintaining active levels in the blood longer than traditional factor IX products. This extension enables effective hemostatic protection and bleeding control with less frequent infusions, thereby balancing quality of life with medical management needs.

Directions for Use:

Preparation:

• Reconstitute the powder with the provided diluent according to the manufacturer's instructions to achieve the intended concentration.
  
• Ensure that the solution is clear and free from particulates before administration.

Administration:

• Administer by intravenous infusion at a rate recommended by a healthcare provider, tailored according to the patient’s baseline factor IX levels, weight, and clinical condition.
  
• Dosing frequency and amount are individualized based on the indication, body weight, and patient response.

Warnings:

• Hypersensitivity Reactions: Immediately discontinue infusion and initiate appropriate treatment if allergic reactions or anaphylactic symptoms occur.
  
• Thromboembolic Events: Be vigilant for signs of thrombosis, especially in patients with risk factors.
  
• Neutralizing Antibodies: Monitor inhibitor development, which may decrease Idelvion’s efficacy. Contact a healthcare provider if expected clotting factor activity levels are not achieved.
  
• Precautions: Store vials in the refrigerator, allowing them to come to room temperature before reconstitution.

Possible Side Effects:

• Common Reactions: Include headache, dizziness, nausea, and mild injection site reactions.
  
• Serious Reactions: Such as anaphylaxis, hypersensitivity, arrhythmia, or thrombosis are rare but may occur.
  
• Other Reactions: Monitor for any unusual or severe symptoms and consult a healthcare provider if concerns arise.

Harness the advancements in recombinant protein therapy with Idelvion by CSL Behring, offering comprehensive bleeding control with extended dosing intervals for Hemophilia B patients. By decreasing dosing frequency while maintaining therapeutic efficacy, Idelvion represents a significant step forward in patient-centric and personalized hemophilia care.