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.

Do you want to continue?

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

SAFETY PROFILE FOR HEMGENIX

Man clasping hands together
Scroll Group 23@3x

Patient portrayal

HEMGENIX was approved by the Food and Drug Administration (FDA) in 2022 and found safe and effective. No adverse effects were considered serious in clinical trials.*

HEMGENIX has been proven safe and effective for years

Bar chart showing clinical trial durations

The most frequent side effects reported with HEMGENIX were:

Liver enzyme (AST) icon

Liver enzyme elevations

Head with pain icon

Headache

Thermometer icon

Flu-like symptoms

Blood bag icon

Infusion-related reactions

Blood cell icon

Blood enzyme elevations

Fatigue icon

Fatigue

Stomach icon

Nausea

FeelingUnwell Icon

Feeling unwell

Couple hiking

No inhibitors to factor IX were reported during the clinical trial

  • Infusion-related reactions (IRRs) occurred in 33% of people, with the majority resolving within a week

-

Symptoms of IRRs may include tightness of chest, headaches, abdominal pain, lightheadedness, flu-like symptoms, shivering, flushing, rash, and elevated blood pressure

  • Most patients had mild elevations in liver enzymes without any symptoms. Some patients were treated with steroids to bring the levels back down.

In clinical trials, people could still use factor IX replacement products if needed. Speak with your doctor about specific situations where factor IX may be needed.

Patient portrayal; HEMGENIX not intended for women

These are not the only side effects possible with HEMGENIX. For additional safety information, please refer to the full prescribing information for HEMGENIX.

*HEMGENIX was studied in people aged 18 years or older with moderately severe to severe hemophilia B, including people with controlled HIV or resolved hepatitis B or C.

Find out what you can expect from treatment

Watch the video

With HEMGENIX ConnectSM, you have access to a dedicated team

Learn more
Amelia
Virtual Assistant
Hello, I am Amelia. How can I help you today? If this is a medical emergency, please call 911 or report to your local emergency room.
toggle chat overlay toggle chat overlay
Top of Page

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.