Elevidys (33.5-34.4 kg)

Elevidys (33.5-34.4 kg)

Elevidys (33.5-34.4 kg)

What is Elevidys (33.5-34.4 kg)?

The doctor will make sure your child has the right gene mutation for treatment with Elevidys (33.5-34.4 kg).

Elevidys (33.5-34.4 kg) may also be used for purposes not listed in this medication guide.

Side effects of Elevidys (33.5-34.4 kg).

If necessary, get emergency medical helpSigns of an allergic reaction: Hives, difficulty breathing, swelling of the face, lips, tongue or throat.

Elevidys (33.5-34.4 kg) can cause serious side effects (even weeks or months after your child receives this treatment). Tell your child's doctor immediately if:

• Liver problems - loss of appetite, nausea, vomiting, stomach pain (top right), fatigue, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• Cold symptoms – runny nose, sneezing, sore throat, fever, cough;

• chest pain, shortness of breath; or

• Difficulty speaking or swallowing, increased muscle pain, weakness or tenderness.

Common side effects of Elevidys (33.5-34.4 kg) may include:

• Fever;

• low blood platelet levels;

• vomiting, nausea; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Warnings

Elevidys (33.5-34.4 kg) can cause serious side effects (even weeks or months after your child receives this treatment). Tell your child's doctor if he or she has chest pain, shortness of breath, difficulty speaking or swallowing, increased muscle pain, weakness, tenderness, jaundice (yellowing of the skin or eyes), or cold symptoms.

Before you take this medicine

Your child should not receive Elevidys (33.5-34.4 kg) if he or she has a certain type of gene mutation. Ask your child's doctor about this risk.

Tell your child's doctor if he or she has or has ever had:

• recently had or are having an infection;

• a history of high levels of a specific type of antibody called anti-AAVrh74;

• heart problems; or

• Liver disease.

Make sure your child has received all vaccinations at least 4 weeks before starting treatment with Elevidys (33.5-34.4 kg).

How is Elevidys (33.5-34.4 kg) administered?

Your child's doctor will do tests before starting treatment with Elevidys (33.5-34.4 kg) to make sure it is the right treatment for your child.

The dosage depends on weight. Your doctor will confirm your child's weight before starting treatment with Elevidys (33.5-34.4 kg).

Elevidys (33.5-34.4 kg) is given in one dose and injected into a vein using an infusion pump. A doctor will give this injection.

Your child will need frequent blood tests before and after taking Elevidys (33.5-34.4 kg).

Your child will be given other medications by mouth before and after taking Elevidys (80-80 lbs) to prevent serious side effects. Your child must take these medicines for as long as the doctor has prescribed. Tell your doctor right away if your child misses a dose or vomits soon after taking this medication.

The child's caregiver should practice proper hand hygiene when in contact with the child's bodily waste for one month after the child receives Elevidys (33.5-34.4 kg). Place any materials that may be in your child's bodily waste in a sealed plastic bag and dispose of it in regular trash.

What happens if I miss a dose?

Elevidys (33.5-34.4 kg) is administered as a single dose and has no dosing schedule.

What happens if I overdose?

In the medical field, an overdose would be treated quickly.

What should I avoid before taking Elevidys (80-80 lbs)?

Follow your child's doctor's instructions regarding any food, drink, or activity restrictions.

What other medications affect Elevidys (33.5-34.4 kg)?

Other medications may affect Elevidys (33.5-34.4 kg), including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.