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

Support for you and your patients

HEMGENIX Connect℠ Expert support at every step

HEMGENIX Connect can help you and your enrolled patients and their caregivers understand the coverage process, work with insurance companies, access financial assistance, and receive resources and support as needed.

DNA helix with two people sitting Patient portrayal; HEMGENIX not intended for women
Man and woman holding hands Patient portrayal; HEMGENIX not intended for women
HEMGENIX Connect provides you with:
  • Answers to product-related questions
  • Access to a dedicated CSL Behring representative
  • Reimbursement/Coordination of care support from the CSL Behring team, including finding in-network treatment centers for your patients
Enrollment provides your patients with:
  • Ongoing commitment to providing additional support and resources
  • Logistics and travel support
  • A dedicated team of CSL experts, including a Patient Resource Navigator and a CSL Case Manager
Patient Resource Navigators will:
  • Provide education on gene therapy and how it works
  • Provide support and guidance on treatment steps with HEMGENIX
  • Work hand in hand with CSL Case Managers to ensure patients know about all possible sources of financial assistance and support

Patient Resource Navigators will not provide personal medical advice. All questions about a patient's individual health needs will be referred to their treating physician.

CSL Case Managers will:
  • Conduct a benefits investigation to assess insurance coverage
  • Determine eligibility for financial and patient assistance programs
  • Enroll patients in the HEMGENIX Copay Program to cover out-of-pocket costs for eligible patients
To learn about enrollment for your patients, call HEMGENIX Connect at 1-833-436-0021, Monday through Friday from 8 AM-8 PM ET.
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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.