Coagulation factor ix recombinant human

IDELVION ®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults 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 IDELVION, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults 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: IDELVION is not indicated for immune tolerance induction in patients with Hemophilia B.

IDELVION is a recombinant protein that temporarily replaces the missing coagulation Factor IX needed for effective hemostasis. IDELVION is comprised of genetically fused recombinant coagulation Factor IX and recombinant albumin. Fusion with recombinant albumin extends the half-life of Factor IX.

For intravenous use after reconstitution only. Each single-dose vial of IDELVION is labeled with the actual Factor IX potency in international units (IU). One IU of IDELVION per kg body weight is expected to increase the circulating activity of Factor IX as follows: Adolescents and adults:

IDELVION is contraindicated in patients who have had life-threatening hypersensitivity reactions to IDELVION, or its components, including hamster proteins. Do not use in patients who have had life-threatening hypersensitivity reactions to IDELVION or its components, including hamster proteins.

Hypersensitivity have been reported. Should symptoms of hypersensitivity reactions including anaphylaxis occur, discontinue IDELVION and administer appropriate treatment. The formation of neutralizing antibodies (inhibitors) to Factor IX has been reported with IDELVION. If expected Factor IX plasma recovery in patient plasma is not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor IX inhibitor concentration. Thromboembolism (e.g., pulmonary embolism, venous thrombosis, and arterial thrombosis) may occur when using Factor IX-containing products. Nephrotic syndrome has been reported following immune tolerance induction with Factor IX-containing products in hemophilia B patients with Factor IX inhibitors and a history of allergic reactions to Factor IX.

The most common adverse reactions (incidence ≥1%) reported in clinical trials were headache, dizziness, hypersensitivity and rash.

Store the IDELVION package in the refrigerator or at room temperature 2-25°C (36 to 77°F). Do not freeze. Store IDELVION in its package to protect from light.