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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.
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This medication is infused 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 treatment. 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.
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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.
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Your condition will be monitored carefully while you are receiving this medication.
You may need blood work done while you are taking this medication.
This medication can cause serious side effects. To reduce the risk, your care team may give you other medications to take before and after receiving this one. Follow the directions from your care team.
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.
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This does not apply. This medication is not for regular use.
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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
-Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
-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.
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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.
DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.
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