Delandistrogene Moxeparvovec-rokl (By injection)
Delandistrogene Moxeparvovec-rokl (del-an-DIS-troe-jeen mox-e-PAR-voe-vek - rokl)
Treats Duchenne muscular dystrophy.
Brand Name(s):
Elevidys
There may be other brand names for this medicine.When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to delandistrogene moxeparvovec-rokl, or if you have deleted exon 8 and/or 9 in DMD gene or with elevated anti-AAVrh74 antibody.How to Use This Medicine:
Injectable
- Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. It must be given slowly, so the IV should remain in place for 1 to 2 hours.
- A nurse or other health provider will give you this medicine.
- Your doctor will also give you other medicines (including steroid medicine) before and after receiving this medicine.
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Your child's vaccines should be completed at least 4 weeks before starting steroid medicine. Ask your child's doctor if you have any questions about this.
Warnings While Using This Medicine:
- Tell your doctor if you are pregnant or breastfeeding, of if you have liver disease, heart disease, infection, or muscle problems.
- This medicine may cause the following problems:
- Infusion-related reactions
- Liver problems
- Muscle problems, including myositis
- Heart problems, including myocarditis
- Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Chest pain, fast heartbeat, trouble breathing
- Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
- Fever, chills, cough, sore throat, body aches
- Muscle pain, tenderness, or weakness
- Unusual bleeding or bruising
If you notice these less serious side effects, talk with your doctor:
- Pain, itching, burning, swelling, or a lump under your skin where the IV is placed
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Last Updated: 9/6/2024
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