Etranacogene Dezaparvovec Suspension for injection

ETRANACOGENE DEZAPARVOVEC (e tra NAK oh jeen dez a PAR voe vek) treats hemophilia B. It works by helping your body make factor IX, a protein that helps your blood clot. This lowers the risk of bleeding.

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Flu-like symptoms—fever, chills, muscle pain, cough, headache, fatigue
• General discomfort and fatigue
• Headache
• Nausea

This medication is given in a hospital or clinic. It will not be stored at home.

They need to know if you have any of these conditions:

• Frequently drink alcohol
• Liver disease
• An unusual or allergic reaction to etranacogene dezaparvovec, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

Interactions are not expected.

This does not apply. This medication is not for regular use.

Your condition will be monitored carefully while you are receiving this medication.

You may need bloodwork while taking this medication.

Do not give blood while taking this medication or after stopping it.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.