Valoctocogene roxaparvovec is used to treat severe hemophilia A in adults.

Your doctor will make sure you can be treated with valoctocogene roxaparvovec.

This medicine may not work for every person who receives it. Talk to your doctor if you have any questions.

Valoctocogene roxaparvovec may also be used for purposes not listed in this medication guide.

You should not be treated with valoctocogene roxaparvovec if you have:

• any active, or uncontrolled chronic infection;
• an allergy to mannitol; or
• cirrhosis or stage 3 or 4 liver fibrosis.

Tell your doctor if you have or have ever had:

• heart disease, a blood clot or stroke;
• any type of hepatitis, HIV;
• a planned surgery or medical procedure;
• abnormal liver function tests;
• if you drink alcohol; or
• any other allergies.

Using valoctocogene roxaparvovec may increase your risk of developing certain types of cancer including liver cancer. Ask your doctor about your individual risk.

Tell your doctor if you recently received a vaccine or are scheduled to receive a vaccine. Your doctor may need to adjust your vaccination schedule.

Make sure you are current on all vaccines before you start using valoctocogene roxaparvovec.

Your name should be listed on a registry to track the effects of this medicine on you.

This medicine is not intended for use by women.

Men and their female partners should use effective birth control to prevent pregnancy. If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose. Ask your doctor about birth control options. Tell your doctor right away if a pregnancy occurs.

Men using valoctocogene roxaparvovec should not donate semen for at least 6 months after treatment.

Use Valoctocogene Roxaparvovec (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during or right after the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, unusual bleeding, or swelling in your face.

Also tell your doctor right away if you have:

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• signs of a blood clot--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, chest pain, shortness of breath, dizziness, coughing up blood, pain, swelling, or warmth in one leg.

Common side effects may include:

• nausea, vomiting, stomach pain;
• abnormal blood tests;
• a reaction after receiving injection; or
• feeling weak or tired, headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using any other medicine for hemophilia A.

Do not drink alcohol for at least a year after receiving this treatment. Dangerous side effects could occur.

Avoid receiving a "live" vaccine while you are being treated with valoctocogene roxaparvovec.

Do not donate blood, organs, tissues, or cells for transplantation after receiving this medicine.