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

Support for you and your patients

HEMGENIX Connect℠

HEMGENIX Connect provides dedicated support that’s customized for you and your patients.

stethoscope image HEMGENIX Connect provides you with:
  • A dedicated reimbursement team to answer any of your financial support questions
  • Answers to product-related questions
  • Assistance with identifying centers trained and approved to administer HEMGENIX
image of hand holding a gear Enrollment provides your patients with:
  • A dedicated team, including a dedicated Patient Resource Navigator and a CSL Case Manager for your patients
  • Insurance assessment to investigate coverage and explain benefits to your patient
    • Many US insurance companies cover HEMGENIX
  • $0 out-of-pocket cost for most commercially insured patients*
  • Determining patient eligibility for financial assistance programs
  • Logistics and travel support for required appointments
  • Ongoing commitment to providing additional support and resources to your patients

*Eligible commercially insured patients pay as little as $0 per month on their prescription. See terms and conditions.

Elevate your expectations for patient support with HEMGENIX Connect

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.