Valoctocogene Roxaparvovec Injection

Uses

For hemophilia (bleeding disorder).

Instructions

This medicine is given as an IV injection into a vein.

This medicine is given gradually through the IV line.

This medicine should be given by a trained health care provider.

You must be monitored by a health care professional for at least 3 hours after each dose is given.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

This medicine is not approved for use by women.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Tell your doctor or nurse right away if fever, chills, skin rash, or shortness of breath develop while the medicine is being given. The medicine may need to be stopped or given at a slower rate.

Avoid alcohol for at least 1 year after treatment with this medicine.

Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 6 months after stopping to prevent pregnancy.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Do not donate blood, organs, tissues, or cells after using this medicine.

Do not donate sperm for 6 months after using this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• headaches
• nausea and vomiting

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• chest or jaw pain
• dizziness
• fainting
• sudden leg pain, swelling, warmth or redness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• shortness of breath
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• excessive or unusual sweating

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Extra

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.