What to expect on infusion day.

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Now that your treatment plan is in place, you’re ready to begin treatment with VYONDYS 53.

Get ready for treatment.

Because VYONDYS 53 is given through a weekly intravenous (IV) infusion, you may have some questions about what you can expect and how you should prepare.

 

Questions?

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How long does an infusion take?

The infusion itself will usually take about 35 to 60 minutes. Plan on some extra time for preparing the IV and medicine. If your child experiences any side effects from the medicine, your doctor or nurse may need to slow or stop the infusion.

We’re going to an infusion center—how should I plan for that?

Usually, you’ll need to plan time for check-in, starting the IV, and preparing and infusing the medicine. It’s a good idea to save the travel instructions to your phone or print them out in advance.

How do I get ready for a home infusion?

Check with the home infusion nurse for information about how to get ready for your child’s infusion.


Ask your healthcare provider if there are any other considerations you should be aware of.

 

 

 

Infusion day tips. Keep your child’s favorite comfort item close by and be sure they have a book, movie, or game to help the time pass more quickly. If you’re traveling to your infusion location, allow extra time for traveling, finding a parking spot, and getting your child inside. Arriving on time will make for a more comfortable infusion day—for everyone.

Infusion step-by-step.

Here’s what you can expect when it’s time for your child’s infusion.

Infusion 1


The nurse may take your child’s vital signs: pulse, temperature, and blood pressure.

Infusion 2


The nurse will prepare the access site and may apply a local anesthetic. If using an IV, the nurse will apply a tourniquet and insert the IV through a needle. If using a port, the nurse will use a needle to access the port.

Infusion 3


The medicine is added to the infusion bag, a 0.2 micron in-line filter is added to the IV tubing, and the infusion is started.

Infusion 4


When the infusion is complete (usually after 35 to 60 minutes), the tubing is flushed with saline to ensure that all medication is received.

Allergic reactions, including rash, fever, itching, hives, and inflammation and/or peeling of the skin have occurred in patients who were treated with VYONDYS 53. Seek immediate medical care if signs and symptoms of allergic reactions occur.

Damage to the kidneys was seen in animals who received golodirsen. Although damage to the kidneys was not seen in clinical studies with VYONDYS 53, potentially fatal kidney damage has occurred with other drugs that work in a similar way. Your doctor may recommend urine and blood testing before starting treatment followed by urine testing every month and a blood test every 3 months to monitor your kidneys.

Adverse reactions that have occurred in at least 20% of patients treated with VYONDYS 53 and more often than in patients who received an inactive intravenous (IV) infusion were headache (41%, 10%), fever (41%, 14%), fall (29%, 19%), pain in the abdomen (27%, 10%), infection of the nose and throat (27%, 14%), cough (27%, 19%), vomiting (27%, 19%), and nausea (20%, 10%).

Other adverse reactions that occurred in greater than 5% of patients treated with VYONDYS 53 and more often than in patients who received an inactive IV infusion were pain at the IV site, back pain, pain, diarrhea, dizziness, stretch or tear in a ligament, bruising, flu, pain in the mouth and throat, stuffy or runny nose, scrapes or scratches of the skin, ear infection, seasonal allergy, fast heartbeat, reactions related to the IV catheter site, constipation, and broken bones.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782).

Please see the full Prescribing Information for VYONDYS 53 (golodirsen).

 

 

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Related FAQs

What happens if I miss an infusion?

Talk to your healthcare provider. If you miss a dose of VYONDYS 53, it may be administered as soon as possible after the scheduled time.

See All FAQs

WHAT IS VYONDYS 53 (golodirsen)?

VYONDYS 53 is used to treat patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the dystrophin gene that can be treated by skipping exon 53.

This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.

Read More

IMPORTANT RISK INFORMATION

Allergic reactions, including rash, fever, itching, hives, and inflammation and/or peeling of the skin have occurred in patients who were treated with VYONDYS 53. Seek immediate medical care if signs and symptoms of allergic reactions occur.

Damage to the kidneys was seen in animals who received golodirsen. Although damage to the kidneys was not seen in clinical studies with VYONDYS 53, potentially fatal kidney damage has occurred with other drugs that work in a similar way. Your doctor may recommend urine and blood testing before starting treatment followed by urine testing every month and a blood test every 3 months to monitor your kidneys.

IMPORTANT RISK INFORMATION

Allergic reactions, including rash, fever, itching, hives, and inflammation and/or peeling of the skin have occurred in patients who were treated with VYONDYS 53.  Seek immediate medical care if signs and symptoms of allergic reactions occur.

Damage to the kidneys was seen in animals who received golodirsen. Although damage to the kidneys was not seen in clinical studies with VYONDYS 53, potentially fatal kidney damage has occurred with other drugs that work in a similar way. Your doctor may recommend urine and blood testing before starting treatment followed by urine testing every month and a blood test every 3 months to monitor your kidneys.

Adverse reactions that have occurred in at least 20% of patients treated with VYONDYS 53 and more often than in patients who received an inactive intravenous (IV) infusion were headache (41%, 10%), fever (41%, 14%), fall (29%, 19%), pain in the abdomen (27%, 10%), infection of the nose and throat (27%, 14%), cough (27%, 19%), vomiting (27%, 19%), and nausea (20%, 10%).

Other adverse reactions that occurred in greater than 5% of patients treated with VYONDYS 53 and more often than in patients who received an inactive IV infusion were pain at the IV site, back pain, pain, diarrhea, dizziness, stretch or tear in a ligament, bruising, flu, pain in the mouth and throat, stuffy or runny nose, scrapes or scratches of the skin, ear infection, seasonal allergy, fast heartbeat, reactions related to the IV catheter site, constipation, and broken bones.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782).

Please see the full Prescribing Information for VYONDYS 53 (golodirsen).