Valoctocogene Roxaparvovec Injection

What is this medication?

VALOCTOCOGENE ROXAPARVOVEC (va lok TOK oh jeen rox a PAR voe vek) treats hemophilia A. It works by helping your body make factor VIII, 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): ROCTAVIAN

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
• Heart disease
• Infection
• Liver disease
• An unusual or allergic reaction to valoctocogene roxaparvovec, mannitol, 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?

• Efavirenz
• Isotretinoin

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 blood work 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.

Talk to your care team about the health of your liver. It is recommended to avoid alcohol for at least one year after treatment. Limiting alcohol use lowers your risk of side effects and helps this medication work as intended.

Contraception is recommended for 6 months after receiving this medication. Your care team can help you find the option that works for you.

Do not donate sperm for 6 months after receiving 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
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• 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

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

• Fatigue
• Headache
• Nausea
• Stomach pain
• Vomiting

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.