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About IDELVION

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About hemophilia B

Hemophilia B is a rare debilitating disorder with severe, moderate, and mild forms that are associated with a lifetime risk of spontaneous and trauma-related bleeding. Hemophilia B is caused by mutations in the F9 gene. This mutation results in a deficiency in Factor IX (FIX), a clotting protein produced by the liver. The severity of hemophilia B is determined by the FIX activity.1

While there are varying treatment approaches based on severity, all current treatment options for hemophilia B involve the intravenous infusion of purified or recombinant FIX.2

What is IDELVION?

IDELVION is a recombinant coagulation FIX protein indicated in children and adults with hemophilia B (congenital FIX deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

IDELVION is not indicated for induction of immune tolerance in patients with hemophilia B.

Please see full prescribing information for IDELVION.
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What are the key benefits?

Only IDELVION delivers

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20% steady-state trough levels achieved with 7-day prophylactic use3

High and sustained FIX levels in clinical trials.
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Zero spontaneous bleeds

Patients who started and stayed on prophylaxis experienced an average of zero spontaneous and joint bleeds, demonstrating that IDELVION has powerful efficacy with both 7- and 14-day dosing.*
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Approved for 7- and 14-day dosing†

Two dosing schedules that meet your patients’ individual needs.

*Of the 23 subjects in Arm 2, 19 were transitioned from on-demand to 7-day prophylaxis. The median annualized spontaneous bleed rate (AsBR) during prophylaxis treatment was 0.7 (range: 0 to 4.2). Data for Arms 1 and 2 were based on matched-pairs design.

†Once well controlled (1 month without spontaneous bleeding or requiring dose adjustments on a weekly dose of ≤40 IU/kg), people aged ≥12 years can be transitioned to 14-day dosing.

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Important Safety Information

The healthcare economic information provided herein is pursuant to Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) and Section 3037 of the 21st Century Cures Act (Public Law 114-255). It is intended for payors, formulary committees, or other similar entities with knowledge and expertise in the area of healthcare economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.

Important Safety Information

IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP), 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 is not indicated for induction of immune tolerance in patients with hemophilia B.

IDELVION is contraindicated in patients who have had life-threatening hypersensitivity reactions to IDELVION or its components, including hamster proteins.

IDELVION is for intravenous use only. IDELVION can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center. For pediatric patients, higher dose per kilogram body weight or more frequent dosing may be needed.

Hypersensitivity reactions have been reported. If patient shows symptoms of hypersensitivity reactions, including anaphylaxis, discontinue IDELVION and administer appropriate treatment.

The formation of neutralizing antibodies (inhibitors) to Factor IX has been reported with IDELVION. If expected Factor IX activity plasma levels are not attained or bleeding is not controlled with appropriate dose, perform an assay to measure Factor IX inhibitor concentration. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.

Thromboembolism (eg, pulmonary embolism, venous thrombosis, and arterial thrombosis) can occur when using Factor IX-containing products. In addition, nephrotic syndrome has been reported following immune tolerance induction 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.

Please see full prescribing information for IDELVION.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Hemophilia B. National Organization for Rare Disorders (NORD). Published June 16, 2020. Accessed June 4, 2021. https://rarediseases.org/rare-diseases/hemophilia-b/ 2. Srivastava A, Santagostino E, Dougall A, et al; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26(suppl 6):1-158. doi:10.1111/hae.14046 3. Santagostino E, Martinowitz U, Lissitchkov T, et al. Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial. Blood. 2016;127(14):1761-1769. doi:10.1182/blood-2015-09-669234

IDELVION is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.

IDELVION® is a registered trademark of CSL Behring Lengnau AG.

Driven by Our Promise™ is a trademark of CSL Behring LLC.

©2022 CSL Behring LLC. The product information presented on this page is intended for US residents only.

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