HEMGENIX IN THE NEWS

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.