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YOU ARE NOW LEAVING THE CURRENT WEBSITE.

The site you are accessing is maintained by a third party over whom CSL Behring
has no control. CSL Behring does not review, approve, or necessarily endorse
viewpoints, inferences, or conclusions stated in or implied by the content of
this site. CSL Behring is not responsible for third-party content or the
consequences of your use thereof.

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MICHAEL IS ONE OF THE MANY WHO HAVE RECEIVED HEMGENIX.

I haven't needed prophy since getting HEMGENIX.

Watch his story

Michael, actual HEMGENIX patient. Patient experiences may vary.

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 * Prescribing Information
 * Important Safety Information
 * For Healthcare Professionals
 * 
 * 
 * 

 * Home
 * Why Gene Therapy
   
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 * About HEMGENIX
   
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    * Results With HEMGENIX
    * Safety
    * How HEMGENIX Works

 * Real-Life Stories
   
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 * Steps to Treatment
   
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 * Patient Support
   
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    * Patient Services
    * Find a Treatment Center
    * Resources and FAQs

 * For Healthcare Professionals

 * Facebook
   
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 * Stay informed
 * Download the app



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the app

DAVID
CONSISTENT
FACTOR IX LEVEL OF
37% FOR YEARS

Patient portrayal;
HEMGENIX not
intended for women

PROVEN SAFE AND EFFECTIVE. STUDIED IN CLINICAL TRIALS SINCE 2018.


STEP INTO A WORLD OF
ELEVATED FACTOR IX
LEVELS THAT
LAST FOR YEARS

A ONE-TIME INFUSION DELIVERS GREATER BLEED PROTECTION*

See the benefits Steps to get started

*In the clinical trial, annualized bleed rate (ABR) for all bleeds
decreased from an average of 4.1 for patients on
prophylaxis (prophy) during the lead-in period to 1.9 (54% reduction)
in months 7-18 after treatment.


SEE THE LONG-TERM RESULTS FOR
PEOPLE WHO HAVE TAKEN
HEMGENIX

See long-term results


FIND OUT WHAT YOU CAN EXPECT FROM
TREATMENT WITH HEMGENIX

Watch the video


YOU MAY BE ELIGIBLE FOR HEMGENIX IF YOU’RE
AN ADULT WITH HEMOPHILIA B AND YOU:

CURRENTLY USE FACTOR IX PROPHYLAXIS (PROPHY) THERAPY

ORHAVE CURRENT OR HISTORICAL LIFE-THREATENING BLEEDING,

ORHAVE REPEATED, SERIOUS SPONTANEOUS BLEEDING EPISODES

--------------------------------------------------------------------------------

Additional Considerations:
 * Have poor venous access or require a port
 * Feel limited by or have issues with infusion schedule
 * Feel that current treatment is not meeting goals
 * Have no factor IX inhibitors
 * Are looking for an innovative treatment option

Discussion Guide


DOWNLOAD APP FOR TRACKING EVERY STEP OF YOUR JOURNEY

 * Track your current treatment; see if gene therapy may be right for you
 * Stay up to date on relevant information and manage your treatment journey





GET UPDATES AND SUPPORT FOR HEMGENIX DELIVERED TO YOUR INBOX

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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.

 * Contact Us
 * Privacy Policy
 * Terms of Use
 * Cookie Policy
 * Site Map
 * CSL Behring
 * About CSL Behring
 * COVID-19 Updates

HEMGENIX is manufactured by uniQure Inc. and distributed by CSL Behring LLC.

HEMGENIX® is a registered trademark and B SUPPORT™ is a trademark of CSL Behring
LLC.

HEMGENIX ConnectSM is a service mark of CSL Behring LLC.

©2024 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA
19406-0901 USA

www.CSLBehring.com USA-HGX-0006-JAN24

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