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HEMGENIX®-logo-bg HEMGENIX® (etranacogene dezaparvovec)

HEMGENIX Resources

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HEMGENIX Prescription Form

Fill out and submit this form to help get your patients started on HEMGENIX.

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HEMGENIX ConnectSM Patient Enrollment Form

Enroll your patients in HEMGENIX Connect by filling out this form.

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HEMGENIX Treatment Guide

Get more information about the steps to a one-time infusion of HEMGENIX.

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Patient Eligibility Brochure

Learn about the eligibility tests required for HEMGENIX, and the optional AAV5 Neutralizing Antibody Test.

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Coding and Reimbursement Guide

Receive helpful direction and examples for the HEMGENIX coding and billing processes.

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Prior Authorization Checklist

Identify and meet common prior authorization requirements for HEMGENIX patients.

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HEMGENIX Treatment Journey Tear Sheet

Confirm your patients’ eligibility and verify coverage to get started with HEMGENIX.

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HEMGENIX Educational Videos

Learn more about HEMGENIX from leading experts in gene therapy and hemophilia B treatment

In these short videos, the experts explore where and why gene therapy fits into the hemophilia B treatment landscape, while discussing the clinical evidence and practical considerations supporting the use of HEMGENIX. Watch them in order or select topics of interest.

Learning Objectives:

  • Understand why hemophilia B is a good target for gene therapy
  • Learn about the clinical trials, efficacy data, and safety profile of HEMGENIX
  • Identify the characteristics of patients for whom HEMGENIX may be an option

This is a paid promotional program presented by the speakers on behalf of CSL Behring LLC.

Videos

Exploring the Unmet Needs and Disease Burden in Hemophilia B Treatment

Review the evolution of treatments for hemophilia B and find out where opportunity remains in meeting the needs of patients.

Why Is Hemophilia B a Good Target for Gene Therapy?

Understand the technology and clinical value of AAV vectors used to deliver gene transfer therapy.

Clinical Evidence Supporting the Use of HEMGENIX for Appropriate Patients

Hear the experts discuss the efficacy and safety results from the phase 2 and 3 (HOPE-B) trials that led to FDA approval of HEMGENIX.

Which Patients Are Eligible for HEMGENIX?

Discover the key characteristics for patient selection and additional clinical factors to consider when identifying patients who may be candidates for HEMGENIX.

Considerations for Practice Readiness

Learn about the recommended steps in prescribing HEMGENIX and the support services available through the entire HEMGENIX journey.

Expert Insights: Addressing the Unmet Need and Impacting the Lives of Patients

Listen as the experts discuss the clinical value of gene therapy and how HEMGENIX can impact the lives of patients with hemophilia B.

Faculty affiliations

photo of faculty member Guy Young

Guy Young, MD

Professor of Pediatrics, University of Southern California; Director, Hemostasis and Thrombosis Center, Children’s Hospital Los Angeles

photo of faculty member Tammuella Chrisentery-Singleton

Tammuella
Chrisentery-Singleton, MD

Chief, Pediatric Hematology; Director, Hemophilia Treatment Center, Mississippi Center for Advanced Medicine

photo of faculty member debbie benson kennedy

Debbie
Benson-Kennedy, MD

Vice President, Medical Affairs, North America, CSL Behring

See frequently asked questions about HEMGENIX

FAQs
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IMPORTANT SAFETY INFORMATION

Warning and Precautions

Infusion Reactions

Infusion reactions, including hypersensitivity reactions and anaphylaxis, may occur. Monitor during administration and for at least 3 hours after end of infusion. If symptoms occur, slow or interrupt administration. Re-start administration at a slower infusion once resolved.

Hepatotoxicity/Hepatocellular Carcinoma

Post-dose, monitor for elevated transaminase levels. Consider corticosteroid treatment should elevations occur. The integration of liver-targeting AAV vector DNA into the genome may carry the theoretical risk of hepatocellular carcinoma development. For patients with preexisting risk factors for hepatocellular carcinogenicity, perform regular (eg, annual) abdominal ultrasound and alpha-fetoprotein testing following administration.

Immune-mediated neutralization of the AAV5 vector capsid

Preexisting neutralizing anti-AAV antibodies may impede transgene expression at desired levels.

Monitoring Laboratory Tests

In addition to monitoring liver function, monitor for Factor IX activity and Factor IX inhibitors after administration.

Adverse Reactions

The most common adverse reactions (incidence ≥5%) were elevated ALT, headache, blood creatine kinase elevations, flu-like symptoms, infusion-related reactions, fatigue, nausea, malaise, and elevated AST.

Indication

HEMGENIX®, etranacogene dezaparvovec-drlb, is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who:

  • Currently use Factor IX prophylaxis therapy, or
  • Have current or historical life-threatening hemorrhage, or
  • Have repeated, serious spontaneous bleeding episodes.

HEMGENIX is for single use intravenous infusion only.

Contraindications: None.

Please see full prescribing information for HEMGENIX.

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.