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#1 Factor IX most prescribed for prophylaxis1

Five-year data report

Examine real-world evidence from a retrospective chart review assessing the impact of switching to IDELVION.2

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Formulary kit

Review product-specific resources for the first gene therapy for hemophilia B.

Prescribing Information
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Prior Authorization
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Financial Support
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About hemophilia B

Hemophilia B is a rare, X-linked hereditary disorder characterized by bleeding, pain, and long-term complications.3-5 Hemophilia B is caused by a defect in a gene encoding coagulation Factor IX (FIX), which is expressed primarily in hepatocytes. The estimated birth prevalence of hemophilia B is 1 in every 20,000 to 25,000 male births.5-7* The severity of hemophilia B typically correlates to native coagulation factor activity. Severe hemophilia B is characterized by spontaneous and/or traumatic bleeding into joints, muscles, and internal organs and can result in reduced life expectancy.4,5

*These data are not specific to the US population.

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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Only IDELVION delivers

20%

steady-state trough levels achieved with 7-day prophylactic use 8,9†

High and sustained FIX levels for adolescents and adults in clinical trials

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ZERO SPONTANEOUS BLEEDS 9‡

Adolescents and adults who started and stayed on prophylaxis experienced a median of zero spontaneous and joint bleeds, demonstrating that IDELVION has powerful efficacy with both 7- and 14-day dosing

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7- AND 14-DAY DOSING §

Two dosing schedules that meet patients’ individual needs

†The average dose for adults and adolescents receiving prophylaxis every 7 days was 37 IU/kg.

‡Of the 23 subjects in Arm 2, 19 were transitioned from on-demand to 7-day prophylaxis. The median AsBR during prophylaxis treatment was 0.7 (range: 0 to 4.2). Data for Arms 1 and 2 were based on matched-pairs design. Median AjBRs (n=21) and IQRs were 0 (0, 0) and 0 (0, 1.04), respectively.

§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.

Abbreviations: AjBR, annualized joint bleeding rate; AsBR, annualized spontaneous bleeding rate; IQR, interquartile range; IU, international unit.

The value of IDELVION

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WITH ITS DOSING OPTIONS, IDELVION IS A HIGHLY COST-EFFECTIVE EXTENDED HALF-LIFE TREATMENT10‖

‖Costs based on wholesale acquisition cost as of April 21, 2026. Annual costs are based on a weighted IU/kg/week across dose options.

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This information is intended for payers, formulary committees, pharmacy benefit managers, or other similar entities with knowledge and expertise to evaluate scientific information on a population basis.

I Acknowledge
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. Data on file. Available from CSL Behring as DOF IDL-006. 2. Escobar M, Yan S, Yang Y, et al. Assessing factor consumption and bleeding outcomes of prophylaxis with 3 commonly prescribed factor IX products for hemophilia B: a retrospective patient medical record analysis in the United States. J Manag Care Spec Pharm. 2026;32(1):105-114. doi:10.18553/jmcp.2025.25148 3. Liras A, Segovia C, Gabán AS. Advanced therapies for the treatment of hemophilia: future perspectives. Orphanet J Rare Dis. 2012;7:97. doi:10.1186/1750-1172-7-97 4. Mannucci PM. Hemophilia therapy: the future has begun. Haematologica. 2020;105(3):545-553. doi:10.3324/haematol.2019.232132 5. Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020;26(suppl 6):1-158. doi:10.1111/hae.14046 6. About hemophilia. Centers for Disease Control and Prevention. March 5, 2025. Accessed April 27, 2026. https://www.cdc.gov/hemophilia/about/ 7. Iorio A, Stonebraker JS, Chambost H, et al. Establishing the prevalence and prevalence at birth of hemophilia in males: a meta-analytic approach using national registries. Ann Intern Med. 2019;171(8):540-546. doi:10.7326/M19-1208 8. Gill JC, Roberts J, Li Y, Castaman G. Sustained high trough factor IX activity levels with continued use of rIX-FP in adult and paediatric patients with haemophilia B. Haemophilia. 2019;25(3):e219-e222. doi:10.1111/hae.13735 9. 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 10. Data on file. Available from CSL Behring as DOF IDL-015.

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

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

©2026 CSL Behring LLC. The product information presented on this page is intended for US residents only.

USA-IDL-0687-AUG26

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