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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

Patient Selection

Perform baseline testing to select patients, including titer testing for Factor IX (FIX) inhibitor presence. Do not administer HEMGENIX®, etranacogene dezaparvovec-drlb, to patients with FIX inhibitors or a history of FIX inhibitors. Perform liver health assessments, consulting with a hepatologist if needed. Also perform laboratory tests to evaluate hepatitis B and C, and postpone treatment if patient has active infection, as this may reduce the efficacy of HEMGENIX and/or increase the risk of adverse reactions.

Warnings and Precautions

Hypersensitivity and Infusion Reactions

Infusion reactions, including hypersensitivity reactions and anaphylaxis, have occurred. Monitor during administration and for at least 3 hours after end of infusion. If symptoms occur, slow or interrupt administration. When symptoms have resolved, restart administration at a slower infusion rate.

Hepatotoxicity/Hepatocellular Carcinogenicity

Hepatotoxicity with elevated liver transaminase has occurred after HEMGENIX treatment. Monitor ALT levels once per week for 3 months and thereafter monthly up to 1 year after administration. Consider corticosteroid treatment should elevations occur and as clinically indicated.

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, consider liver ultrasound and alpha-fetoprotein testing following administration, and monitor for hepatocellular carcinomas for five years following administration of HEMGENIX.

Immune-Mediated Neutralization of the AAV5 vector capsid

Preexisting neutralizing anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with HEMGENIX, all patients developed neutralizing anti-AAV5 antibodies to AAV5 vector capsid.

Monitoring Laboratory Tests

Monitor patients regularly for FIX activity (eg, weekly for 3 months), especially when exogenous FIX is administered, as it may take several weeks following HEMGENIX administration before hemostatic control becomes apparent. Hemostatic support may be needed for some patients. Monitor patients through appropriate clinical observations and laboratory tests for the development of inhibitors to FIX.

Adverse Reactions

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

Indication

HEMGENIX is 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.

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.