Etuvetidigene Autotemcel (e-tue-ve-TI-di-jeen aw-toe-TEM-sel)

Treats Wiskott-Aldrich syndrome.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine must be given slowly, so your IV will need to stay in place for at least 30 minutes.
• A nurse or other health provider will give you this medicine.
• You may also receive other medicines (including cancer medicine, allergy medicine) before receiving this medicine.
• This medicine is made specifically for each patient, using the patient's own blood cells. Your doctor will collect your blood through a procedure called mobilization and apheresis. Talk with your doctor if you have any concerns about this.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use medicine to treat HIV for at least 1 month before this infusion until at least 7 days after receiving this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive a live vaccine until recovery following treatment with this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. If you can get pregnant, you must have a negative pregnancy test before this infusion. Male patients with female partners should use an effective form of birth control before this infusion and for at least 6 months after the last dose.
• Tell your doctor if you are breastfeeding, or if you have liver disease, any type of infection, or a history of dimethyl sulfoxide (DMSO) allergy.
• This medicine may cause the following problems:
  • Infusion-related reactions
  • Serious infections
  • Liver problems, including hepatic veno-occlusive disease
  • Increased risk for cancer
• This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Do not donate blood, organs, tissues, or cells at any time in the future.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, lower back or side pain, painful or difficult urination
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Unusual bleeding, bruising, or weakness

Call your doctor right away if you notice any of these side effects:

• Bloody nose
• Diarrhea
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088