Onasemnogene Abeparvovec Injection (ONASEMNOGENE ABEPARVOVEC - INJECTION)

Instructions

This is an IV medicine. It is given through a sterile tube directly into the vein by a healthcare provider.

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

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.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Small amounts of virus may shed in the stool for up to 1 month after the injection. Ask the doctor how to handle and dispose of waste materials (such as diapers) for up to 1 month after the injection.

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

Cautions

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

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Contact your doctor if you develop any signs of a new infection such as fever, cough, sore throat, or chills.

Wash your hands often and avoid close contact with people with infections such as colds and flu.

Speak with your health care provider before receiving any vaccinations.

Do not donate blood, organs, tissues, or cells 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.

• vomiting

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

• bleeding or bruising
• signs of kidney damage (such as change in urine color or bubbly urine)
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• seizures

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.