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)

GETTING STARTED WITH HEMGENIX

See how to get started with HEMGENIX and learn what you can expect during the treatment journey.

Steps to getting started with treatment

Speech bubbles icon

Discuss HEMGENIX with your doctor

Consider discussing HEMGENIX with your doctor if you are an adult with hemophilia B and you:

  • Checkmark icon
    Currently use factor IX prophylaxis therapy
  • Checkmark icon
    or have current or historical life-threatening bleeding
  • Checkmark icon
    or have repeated, serious spontaneous bleeding episodes.

Additional considerations:

  • Have poor venous access or require a port
  • Feel limited by or have issues with your current infusion schedule
  • Current treatment is not meeting goals

Want to be prepared for a discussion with your doctor? Download the Doctor Discussion Guide.

Read more

antibody testing icon

Confirm eligibility

You will work with your doctor to determine if you are eligible for HEMGENIX. Your doctor may consider your lifestyle and commitment to follow-up. Additionally, you will be screened for:

  • Factor IX inhibitors—This will be assessed with standard blood work
  • Overall liver health—This will be assessed by standard blood work and imaging

Required pre-screening tests*

Test type
Method
Eligibility
Checkmark icon

Screen for factor IX inhibitors

Factor IX inhibitor test

Checkmark icon

Assess liver health†

Liver enzyme tests

Liver ultrasound

Elastography: A noninvasive procedure to study the liver

Blood test

Blood test

Ultrasound

Ultrasound

No factor IX inhibitors

Liver is in good health

*Additional tests may be required.

†If the liver health screening tests produce an abnormal result, your doctor may refer you to a hepatologist to further assess eligibility for HEMGENIX.

Required pre-screening tests*

Test type
Method

Blood test

Blood test

Ultrasound

Ultrasound

No factor IX inhibitors

Liver is in good health

Checkmark icon

Screen for factor IX inhibitors

Factor IX inhibitor test

Checkmark icon

Assess liver health†

Liver enzyme tests

Liver ultrasound

Elastography: A noninvasive procedure to study the liver

*Additional tests may be required.

†If the liver health screening tests produce an abnormal result, your doctor may refer you to a hepatologist to further assess eligibility for HEMGENIX.

If your doctor’s office or hemophilia treatment center isn’t an administration center for HEMGENIX, your doctor can recommend one.

These centers are treatment centers with staff prepared and trained on the administration of HEMGENIX.

While you're going through the screening process, you can enroll in HEMGENIX Connect℠ to start taking advantage of support such as:

  • Your dedicated team, including a Patient Resource Navigator and a CSL Case Manager
  • Insurance assessment to investigate coverage and explain your benefits
  • Determination of eligibility for financial assistance programs
  • Logistics and travel support
  • Ongoing commitment to providing additional support and resources
HEMGENIX Connect℠ HEMGENIX Connect℠

Enroll online, or call 1-833-436-0021 Monday through Friday, 8 AM-8 PM ET.

Your Patient Resource Navigator can advise you of potential next steps, and your CSL Case Manager can start to conduct a benefits investigation to determine potential coverage while screenings are underway.

Read more

IV infusion bag icon

One-time dose

Since HEMGENIX is administered as a one-time IV infusion, the infusion occurs during just one appointment at the administration center. Once it’s on the calendar, just follow any preparation instructions from the doctor who will be administering HEMGENIX.

1 hour clock icon

Before administering HEMGENIX, the staff may conduct a few additional tests—but the infusion itself usually takes about 1-2 hours.

Once administration is complete, you will stay at the center for at least 3 hours so that the staff can monitor your vital signs and make sure you are ready to return home.

Read more

reporting chart icon

Track progress

After your infusion of HEMGENIX, talk to your doctor about a tailored follow-up plan to track your progress.

It’s important to track your overall health, liver health, and factor IX activity levels after the infusion. You will need to track them weekly for the first 3 months so your doctor can monitor your response to HEMGENIX.

1x a week for the first 3 months

If your liver enzyme levels increase, your doctor may prescribe a steroid to help maintain consistent factor IX levels. Additionally, you and your doctor will be able to monitor for elevated and sustained factor IX activity levels over time.

Your doctor will provide a follow-up plan that works best for you.

Potential options include:

Blood drop icon

Going to your treating hematologist’s office to have blood work done

Telemedicine icon

Going to a local lab that is closer to your home and then having follow-up telemedicine appointments with your doctor as needed

Administration center building icon

Going to the administration center

People with preexisting risk factors for a certain kind of liver cancer called hepatocellular carcinoma will also receive annual blood work and ultrasound screenings to track liver health in the 5 years following treatment with HEMGENIX.

Read more

With HEMGENIX ConnectSM, you have access to a dedicated team

Learn more

Downloadable support tools and resources are available

Go to HEMGENIX resources
Top of Page

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.