Preparing For Your Treatment

Please read the HEMGENIX® Patient Information Leaflet before treatment.

BEFORE YOUR TREATMENT

It is important that you fully understand the potential benefits and risks of HEMGENIX® treatment — for example, what is currently known and not yet known about the long-term effects of this therapy, in relation to both safety and efficacy.

If you have questions about HEMGENIX®, your care team will be happy to help. 

IS HEMGENIX® RIGHT FOR YOU?

To know whether HEMGENIX® is right for you, you will need to undergo some tests to check whether you will be eligible for treatment.

Antibody blood tests1

Your doctor will conduct blood tests to check for certain antibodies (proteins) before treatment with HEMGENIX®, including:

  • Blood tests to check for the presence of antibodies in your blood directed against the human FIX protein (FIX inhibitors). If you test positive for these antibodies, another test will be performed in approximately 2 weeks. If both test results are positive, HEMGENIX® will not be administered
  • Blood tests to check for the amount of antibodies in your blood directed against the type of virus used to make HEMGENIX® may also be performed
Liver health1

In order to decide if HEMGENIX® is suitable for you, your doctor will check the status of your liver health before you start treatment and perform:

  • Blood tests to check liver enzyme levels in your blood
  • Blood tests to check active liver infection (hepatitis B and C)
  • Liver ultrasound
  • Elastography testing to check for scarring or thickening of your liver

THINGS TO CONSIDER BEFORE YOU RECEIVE HEMGENIX® 

HEMGENIX® treatment cannot be reversed after you have received it. You will need to think carefully about how it may affect your life and be aware of the psychosocial effects, lifestyle requirements, and logistical considerations. For example:2,3

  • How you see yourself as an individual with haemophilia B and how you will adapt to change
  • Being able to attend regular appointments
  • Intimacy and family planning
  • Alcohol consumption

The decision about whether to have gene therapy, and when to have it, is a personal one. You do not need to make the decision alone. You will have conversations with your haemophilia care team, and you may wish to discuss with patient organisations, family, and friends. Psychological support is also available if you need it — please speak to your care team about this.

Remember, you can take as much time as you need — there is no rush to make a decision.

If you decide to go ahead with gene therapy, you will be asked to sign a consent form. This shows that you fully understand the treatment and all the potential benefits and risks. 

References

1. HEMGENIX® (etranacogene dezaparvovec). Summary of product characteristics. 2. Fletcher S et al. Expectation and loss when gene therapy for haemophilia is not an option: An exigency sub-study. Haemophilia. 2023;29(3):776–783. 3. CSL Behring. Gene Therapy Academy. From Clinical Trial to Clinical Practice and Beyond. Amsterdam, 25–26 January 2024.

Reporting side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme. By reporting side effects, you can help provide more information on the safety of this medicine. Adverse events should also be reported to CSL Behring UK Ltd on 01444 447 405 or at medinfo@cslbehring.com.
 

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See above for how to report side effects.