elivaldogene autotemcel

What is the most important information I should know about elivaldogene autotemcel?

What is elivaldogene autotemcel?

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.

What should I discuss with my healthcare provider before receiving elivaldogene autotemcel?

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.

How is elivaldogene autotemcel given?

Follow all directions on the prescription label and read all medication guides or instruction sheets.

Elivaldogene autotemcel is injected into a vein by a healthcare provider. Your child will be given other medicines as part of the treatment with elivaldogene autotemcel.

After elivaldogene autotemcel injection, your child may stay in the hospital for approximately 2 months to monitor the recovery. Your child's doctor will determine when your child can go home.

This medicine may cause false results on a HIV (human immunodeficiency virus) test. Tell the laboratory staff that your child uses elivaldogene autotemcel.

Blood will need to be tested often.

Elivaldogene autotemcel may increase the risk of cancer. Ask a healthcare provider about your child's risk.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving elivaldogene autotemcel?

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

What are the possible side effects of elivaldogene autotemcel?

• 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.

What other drugs will affect elivaldogene autotemcel?

Tell the doctor about all your child's other medicines, especially:

• HIV/AIDS medications.

This list is not complete. Other drugs may affect elivaldogene autotemcel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your child's doctor or pharmacist can provide more information about elivaldogene autotemcel.