Elivaldogene Autotemcel Injection

What is this medication?

ELIVALDOGENE AUTOTEMCEL (EL i VAL doe jeen AW toe TEM sel) treats cerebral adrenoleukodystrophy (CALD). It works by helping your body make more of a protein needed to support the protective membrane that covers nerve cells in your brain and spinal cord. This delays worsening symptoms.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): SKYSONA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Infection
• An unusual or allergic reaction to elivaldogene autotemcel, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you before receiving this medication. Be sure to read this information carefully.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 4 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

• Vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need blood work done while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Do not donate blood after receiving this medication.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Use a condom during sex during treatment and for 6 months after stopping treatment. Tell your care team right away if you think your partner might be pregnant. It is unknown if this medication can cause serious birth defects.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Infection—fever, chills, cough, or sore throat
• Seizures

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Constipation
• Diarrhea
• Loss of appetite
• Headache
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.