Etranacogene Dezaparvovec Injection

What is this medication?

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 medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): HEMGENIX

What should I tell my care team before I take this medication?

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

How should I use this medication?

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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

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

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

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.

What side effects may I notice from receiving this medication?

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 list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

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

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.