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hemgenix-logo-bg mobile-menu-bg HEMGENIX® (etranacogene dezaparvovec-drlb)

RESOURCES

DESIGNED FOR YOU

DNA spiral with people talking Patient portrayal; HEMGENIX not intended for women
Downloadable resources that can provide additional information about HEMGENIX
HEMGENIX Connect℠ brochure thumbnail
HEMGENIX ConnectSM Brochure

Provides additional information on the HEMGENIX Connect patient support program and lets you know what to expect during your treatment journey

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HEMGENIX patient brochure thumbnail
HEMGENIX Patient Brochure

What you can expect from the first and only gene therapy for hemophilia B, including results of HEMGENIX from studies and how to get started with treatment

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Doctor Discussion Guide

Provides key topics to discuss with your doctor if you are considering treatment with HEMGENIX

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Download BSupport App logo App for tracking every step of your journey

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  • Track your current treatment and see if gene therapy may be right for you
  • Find out if you’re eligible for gene therapy and if it’s right for you
  • Stay up to date on relevant information and manage your treatment journey
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B Support app Google Play store QR code B Support app Google Play link
BSupport App Images
Frequently asked questions about HEMGENIX

Read below to see answers to some frequently asked questions. If you have a question about HEMGENIX that is not listed below, be sure to discuss it with your doctor or dedicated HEMGENIX Connect team.

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HEMGENIX is the first and only gene therapy for hemophilia B See study results
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IMPORTANT SAFETY INFORMATION

What is HEMGENIX?

HEMGENIX®, etranacogene dezaparvovec-drlb, is a one-time gene therapy for the treatment of adults with hemophilia B who:

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

HEMGENIX is administered as a single intravenous infusion and can be administered only once.

What medical testing can I expect to be given before and after administration of HEMGENIX?

To determine your eligibility to receive HEMGENIX, you will be tested for Factor IX inhibitors. If this test result is positive, a retest will be performed 2 weeks later. If both tests are positive for Factor IX inhibitors, your doctor will not administer HEMGENIX to you. If, after administration of HEMGENIX, increased Factor IX activity is not achieved, or bleeding is not controlled, a post-dose test for Factor IX inhibitors will be performed.


HEMGENIX may lead to elevations of liver enzymes in the blood; therefore, ultrasound and other testing will be performed to check on liver health before HEMGENIX can be administered. Following administration of HEMGENIX, your doctor will monitor your liver enzyme levels weekly for at least 3 months. If you have preexisting risk factors for liver cancer, regular liver health testing will continue for 5 years post-administration. Treatment for elevated liver enzymes could include corticosteroids.

What were the most common side effects of HEMGENIX in clinical trials?

In clinical trials for HEMGENIX, the most common side effects reported in more than 5% of patients were liver enzyme elevations, headache, elevated levels of a certain blood enzyme, flu-like symptoms, infusion-related reactions, fatigue, nausea, and feeling unwell. These are not the only side effects possible. Tell your healthcare provider about any side effect you may experience.

What should I watch for during infusion with HEMGENIX?

Your doctor will monitor you for infusion-related reactions during administration of HEMGENIX, as well as for at least 3 hours after the infusion is complete. Symptoms may include chest tightness, headaches, abdominal pain, lightheadedness, flu-like symptoms, shivering, flushing, rash, and elevated blood pressure. If an infusion-related reaction occurs, the doctor may slow or stop the HEMGENIX infusion, resuming at a lower infusion rate once symptoms resolve.

What should I avoid after receiving HEMGENIX?

Small amounts of HEMGENIX may be present in your blood, semen, and other excreted/secreted materials, and it is not known how long this continues. You should not donate blood, organs, tissues, or cells for transplantation after receiving HEMGENIX.

Please see full prescribing information for HEMGENIX.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You can also report side effects to CSL Behring’s Pharmacovigilance Department at 1-866-915-6958.