Elivaldogene autotemcel is used to slow nerve damage in boys 4 to 17 years old with early, active cerebral adrenoleukodystrophy (CALD), a genetic disease that may damage the brain.

Elivaldogene autotemcel may also be used for purposes not listed in this medication guide.

Tell the doctor if your child has ever had:

• liver or kidney disease;
• an allergy to dimethyl sulfoxide (DMSO, a preserving agent); or
• if your child has an active infection.

It may be harder for your child to get a female pregnant while using this medicine. Your child should still use birth control to prevent pregnancy until at least 6 months after administration of elivaldogene autotemcel.

Use Elivaldogene Autotemcel (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 your child has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call the doctor at once if your child has:

• signs of blood cancer--bruising or bleeding, blood in the urine or stool, severe headache, stomach or back pain, swollen glands, or vomiting or coughing up blood;
• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• low blood cell counts--mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

• fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• skin sores, easy bruising, pale skin, cold hands and feet, feeling light-headed or short of breath;
• leg cramps, irregular heartbeats, fluttering in the chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
• sores or white patches in or around the mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
• nausea, vomiting, loss of appetite, stomach pain, constipation, diarrhea;
• hair loss;
• headache; or
• rash.

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

Your child should avoid donating blood, organs, tissues, or cells.