Etranacogene Dezaparvovec Injection (ETRANACOGENE DEZAPARVOVEC - 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.

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.

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

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.

Tell your doctor or nurse right away if any of these happen while the medicine is being given: chest pain, headache, abdominal pain, dizziness, lightheadedness, feeling of heat or flushing, or flu-like symptoms, such as body aches, fever or chills. The medicine may need to be stopped or given at a slower rate.

This medicine may cause dizziness or fainting, especially after exercising or in hot weather. Be very careful when standing or sitting up quickly.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

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

Side Effects

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

• severe or persistent abdominal pain
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• severe or persistent vomiting

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.