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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 1.01. Revision date: 1/9/2023.