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

HEMGENIX can
eliminate prophy
from your life

a one-time infusion

of HEMGENIX delivers elevated
factor lX levels for years

HEMGENIX was studied in an international gene therapy clinical trial. 54 adults with moderately severe or severe hemophilia B were enrolled in the trial. Before their one-time dose of HEMGENIX, all people in the clinical trial were taking factor IX prophy to treat their hemophilia B. They were observed for at least 6 months on their prophy treatment before receiving HEMGENIX (this is called the lead-in period). During this time, the number of bleeds and the use of factor IX prophy were recorded.
Remain Prophy-free
Factor IX Activity
94%

OF PEOPLE ON HEMGENIX REMAINED PROPHY-FREE

HEMGENIX can eliminate prophy from your life by allowing you to make your own factor IX

Pie chart showing 94% 51 out of 54 people remained free of routine factor IX prophy

Of the 3 that didn't discontinue prophy:

  • One person who did not respond to treatment did not discontinue prophylaxis

  • One person who received a 10% partial dose of treatment did not discontinue prophy

  • During months 7–18, an additional person received factor IX prophy from days 396–534 (approximately 20 weeks)

If medically necessary, factor IX replacement products can still be used. Talk to your doctor about if this may be needed.

94%

OF PEOPLE MAINTAINED MILD-NORMAL FACTOR IX LEVELS*

37% average factor IX activity level for years

Proportion of patients within different factor IX activity ranges at 2 years (n=54)

Pie chart of proportion of patients within different FIX activity ranges

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

* 49 of the 52 responders expressed mild-normal factor levels at 2 years.

† Factor IX activity data is missing at 24 months for one 77-year-old person due to death (unrelated to HEMGENIX) at 15 months after gene therapy. Factor IX activity resulting from gene therapy is not interpretable for one person at 24 months due to blood sampling near the time of a factor IX concentrate infusion.

‡ Two patients did not respond to HEMGENIX treatment and were not able to stop routine prophylaxis.

HEMGENIX has been
proven safe for years

See the safety profile

Find out what you can expect from treatment

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IMPORTANT SAFETY INFORMATION

Before you can receive HEMGENIX®, etranacogene dezaparvovec-drlb, your doctor will perform tests to check for Factor IX inhibitors. If you have inhibitors, or have had them in the past, you are not a candidate for HEMGENIX. Your doctor will also check your liver health and screen for hepatitis B and C, as active infection may affect how well the treatment works or increase the risk of side effects.

Infusion-related and allergic reactions (including anaphylaxis) can occur. You will be monitored throughout infusion and for at least 3 hours afterward. If a reaction occurs during infusion, the infusion may be slowed or interrupted as symptoms are addressed, then started at a slower rate once symptoms have resolved.

Liver effects including liver injury can occur. Your doctor will monitor your liver with blood tests every week for 3 months and then monthly up to 1 year after treatment. Increased liver enzymes may require corticosteroid treatment. Because HEMGENIX works in the liver, there is a potential (possible but not proven) risk of liver cancer, and some patients may be monitored for up to 5 years.

After treatment, your body will develop antibodies to HEMGENIX, which may affect how well it works.

Your doctor will monitor Factor IX levels and check for inhibitors. You may still need support to help control bleeding, especially in the initial weeks after treatment.

Most common side effects include increased liver enzymes, headache, increased blood creatine kinase, 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.

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.

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.

Please see full prescribing information for HEMGENIX.