Delandistrogene moxeparvovec-rokl (intravenous route)

Elevidys

Delandistrogene moxeparvovec-rokl injection is used to treat Duchenne muscular dystrophy (DMD) in patients with a confirmed specific genetic mutation. DMD is a rare, inherited muscle disease that is caused by absence of a protein called dystrophin, which helps keep muscle cells intact. This medicine is to be given only by or under the direct supervision of a doctor. This product is available in the following dosage forms:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of delandistrogene moxeparvovec-rokl injection in children 4 years of age and older. Safety and efficacy have been established. Appropriate studies have not been performed on the relationship of age to the effects of delandistrogene moxeparvovec-rokl injection in geriatric patients. Safety and efficacy have not been established. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: