Fidanacogene Elaparvovec Injection

What is this medication?

FIDANACOGENE ELAPARVOVEC (FYE da NAK oh jeen EL 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): BEQVEZ

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
• HIV or AIDs
• Liver disease
• An unusual or allergic reaction to fidanacogene elaparvovec, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is infused 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?

• Alcohol

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. It is important to have regular check-ups and blood work done after you receive this treatment.

Talk to your care team about ways to maintain or improve the health of your liver. Drinking alcohol may increase the risk of liver injury.

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.

This medication is present in body fluids, such as urine, feces, and saliva for up to 6 months after treatment. Talk to your care team about how to limit exposure. Wash your hands after using the bathroom and before preparing or handling food.

Do not donate blood, organs, tissues, or cells any time after receiving this treatment.

If your partner can get pregnant, use a condom during sex for 6 months after receiving this treatment.

Do not donate sperm for 6 months after receiving this treatment.

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
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• 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

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.