Delandistrogene Moxeparvovec Injection

What is this medication?

DELANDISTROGENE MOXEPARVOVEC (DEL an DIS troe jeen MOX e PAR voe vek) treats Duchenne muscular dystrophy (DMD), an inherited condition that causes muscle weakness. It works by helping your body make a protein (dystrophin) that supports and protects muscles. This may delay 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): ELEVIDYS

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

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

• Heart disease
• Infection
• Liver disease
• Recent or upcoming vaccine
• An unusual or allergic reaction to delandistrogene moxeparvovec, other medications, foods, dyes, or preservatives

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.

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?

Interactions are not expected.

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 you are taking this medication.

After gene therapy, it is important avoid contact with the treated person's body fluids for 1 month. Body fluids include saliva, urine, stool, blood, and semen. By avoiding contact, the gene therapy will not affect others by accident. Wash hands with soap and water after coming into contact with body fluids and before eating. Use disposable gloves. Place items that have body fluids on them, such as diapers, in a sealed bag. Get rid of the bag in the regular trash.

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
• Heart muscle inflammation—unusual weakness or fatigue, shortness of breath, chest pain, fast or irregular heartbeat, dizziness, swelling of the ankles, feet, or hands
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Muscle inflammation—unusual weakness or fatigue, muscle pain, trouble swallowing or breathing

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

• Fever
• Nausea
• 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.