What to Expect After Your ELEVIDYS Infusion

There are three key things to keep in mind after an ELEVIDYS infusion: Ongoing Patient Monitoring, ELEVIDYS Side Effects, and Safe Handling of Body Waste.

To make sure all is well after the infusion, your Gillette care team will continue to monitor the patient closely. Here’s what you can expect in the days and weeks after the infusion.

• The patient will have blood work done weekly for 12 weeks, starting from the infusion date. If the patient is tolerating the infusion as expected, that makes 12 labs total. If the patient experiences negative side effects after the infusion, more labs may be needed. Depending on your provider’s recommendation, you may also have blood work done on day 3 post-infusion.
• The patient will have several virtual visits with Drs. Eskuri or Richardson over the next 8 weeks. These will be scheduled for you before your infusion. If there are side effects, you may need to meet more frequently.
• The patient will continue their high-dose steroid schedule for 8 weeks. If bloodwork is normal, beginning in week 9, he will begin weaning off the steroids back to the patient’s baseline. Your provider will share weaning instructions at the week 8 virtual visit.

After your ELEVIDYS infusion, there are some side effects to watch out for. The following safety information is not comprehensive. Please refer to the Sarepta handout for more details. If there are any side effects that bother the patient, or that don’t go away that are not listed below, please call Gillette Telehealth to discuss them.

Call Gillette Telehealth immediately if the patient:

• Develops any sign of allergic reaction

Rarely, patients can develop hives or other signs of an allergy to the ELEVIDYS infusion. This usually happens within 2 hours of the infusion, so our team will monitor the patient closely for 3 hours after the infusion. However, if any signs or symptoms of allergy develop after going home, call Telehealth right away.

***If the patient develops any difficulty breathing, mouth or tongue swelling, or other signs of anaphylaxis, CALL 911***

• Misses a dose of steroids

Contact a healthcare provider immediately if he misses a dose of steroid, or he vomits it up.

• Skin and/or whites of the eyes appear yellowish

Yellowing of the skin or eyes can be a sign that the liver is inflamed or not functioning properly. To check the patient's liver, more lab testing may be ordered.

• Shows signs of infection

Due to steroid use, an infection (cold, flu, stomach flu, ear or respiratory infection, etc.) before or after ELEVIDYS could lead to more serious complications. Call your doctor immediately if you see symptoms of infection like coughing, wheezing, sneezing, runny nose, sore throat, or fever.

• Has unexplained muscle weakness

Caregivers should contact a healthcare provider immediately if the patient experiences any unexplained increased muscle pain, tenderness, or weakness, including difficulty swallowing, breathing, or speaking, as these may be symptoms of myositis.

• Experiences chest pain or shortness of breath

Caregivers should contact a healthcare provider immediately if the patient begins to experience chest pain and/or shortness of breath, unexplained weight gain, or swelling in the legs. If the patient has cardiac symptoms, more frequent post-infusion monitoring or even hospitalization may be required.

After receiving ELEVIDYS, the patient temporarily sheds the virus used to deliver the gene product through their body fluids and waste. These virus particles can be in pee, poop, saliva, and vomit. They cannot make anyone sick, but they can cause an immune response. To protect others around you from developing an immune response, our team suggests wearing a mask out in public for the first 30 days after your infusion.

Patients and caregivers should wash their hands thoroughly when touching a patient’s body waste. Place materials that may have the patient’s bodily fluids/waste in a sealable bag and throw into the trash. Precautions should be followed for one month after ELEVIDYS infusion. By taking proper safety precautions, you will minimize your risk. If you are exposed, it might affect your future gene therapy options. Remember, good hygiene helps keep everyone safe!

Questions?

Contact the Neuromuscular Team 651-726-2665 option 3
or
Send a message through the MyGillette Patient Portal

Patient Illness Before Infusion or Other Issue?
Contact Telehealth Nursing
651-229-3890