Vyondys 53 is a brand-name prescription medication. It’s approved by the Food and Drug Administration (FDA) to treat Duchenne muscular dystrophy (DMD) in adults and children with a certain gene mutation. (A gene mutation means that a specific gene isn’t working the way it should.)

Before taking Vyondys 53, your doctor will order a genetic test to determine whether this drug is right for you. Vyondys 53 is used to treat DMD in people who have a confirmed mutation of the DMD gene that can be treated by skipping exon 53. For more information on how Vyondys 53 works, including an explanation of exons and exon skipping, see the “How Vyondys 53 works” section below.

Drug details

Vyondys 53 comes as a clear liquid solution in vials. It’s given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. The infusion is given by your doctor or other healthcare provider. You’ll likely receive this infusion at the doctor’s office or an infusion clinic. In some cases, you may get the infusion at home from a healthcare provider.

Vyondys 53 comes in one strength: 50 milligrams per milliliter (mg/mL). The active drug in Vyondys 53 is golodirsen. Golodirsen belongs to a drug class called antisense oligonucleotides. (A drug class is a group of medications that work in a similar way.)

FDA approval

In 2019, the FDA approved Vyondys 53 under its accelerated approval laws. Accelerated approval is based on information the FDA reviews from early clinical trials of the drug. The FDA won’t make a decision on full approval of Vyondys 53 until after additional clinical trials are completed.

Usually, medications receive approval from the FDA once extensive studies are completed. But, for certain drugs like Vyondys 53, approval may be granted before all studies have been finished. Accelerated approval is reserved for medications used for conditions that don’t have a lot of successful treatment options. This allows access to treatment for people who otherwise would have little or no treatment options for their condition.

For example, Vyondys 53 is only the second exon-skipping medication the FDA has approved to treat DMD. In addition, it’s the only medication that treats a DMD gene mutation that can be treated by skipping exon 53.

Further trials are still being conducted to confirm the FDA’s approval of Vyondys 53 for this condition.

Orphan drug status

Vyondys 53 has received orphan drug status (sometimes called “orphan designation” or “orphan status”) from the FDA.

For more information on what orphan drug status is, see the “Common questions about Vyondys 53” section below.

Effectiveness

For information about the effectiveness of Vyondys 53, see the “Vyondys 53 uses” section below.

Vyondys 53 is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Vyondys 53 contains the active drug golodirsen.

As with all medications, the cost of Vyondys 53 can vary. To find current prices for Vyondys 53 in your area, check out GoodRx.com.

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you may have to get Vyondys 53 from a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Vyondys 53, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need prior authorization for Vyondys 53, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Vyondys 53, or if you need help understanding your insurance coverage, help is available.

Sarepta Therapeutics, Inc., the manufacturer of Vyondys 53, offers a program called SareptAssist that may help lower the cost of this drug. For more information and to find out if you’re eligible for support, call 888-SAREPTA (888-727-3782) or visit the manufacturer’s website.

Generic version

Vyondys 53 is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

The Vyondys 53 dosage your doctor prescribes will depend on several factors. These include:

  • your body weight in kilograms (kg)
  • side effects or reactions you may have to Vyondys 53 infusions

The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Vyondys 53 comes as a clear liquid solution in vials. This drug is available in one strength: 50 milligrams per milliliter (mg/mL). It’s given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. The infusion is given by your doctor or other healthcare provider. You’ll likely receive this infusion at the doctor’s office or an infusion clinic. In some cases, you may get the infusion at home from a healthcare provider.

Dosage for Duchenne muscular dystrophy

The recommended Vyondys 53 dosage for treating Duchenne muscular dystrophy (DMD) is based on your body weight. Vyondys 53 is given at a dose of 30 mg per kilogram (kg) of body weight. (One kg is equal to about 2.2 pounds [lb].) The dose is given once a week.

For example, a person weighing 132 lb (60 kg) would receive a weekly Vyondys 53 dose of 1,800 mg.

A Vyondys 53 infusion typically lasts 35 to 60 minutes. If you have an allergic reaction (such as a rash or itchiness) during a Vyondys 53 infusion, your doctor may try slowing down your infusion. Giving the medication over a longer period of time may help your body tolerate the infusion better.

For more information on allergic reaction, see the “Vyondys 53 side effects” section below.

Children’s dosage

The Vyondys 53 children’s dosage for DMD is the same as that for treating the condition in adults. See the “Dosage for Duchenne muscular dystrophy” section directly above.

What if I miss a dose?

It’s important to keep your appointments for your Vyondys 53 infusions. If you miss your appointment, call your doctor’s office right away to reschedule. They’ll help get an infusion scheduled for you as soon as possible. They can also help you schedule or reschedule your future doses.

To help make sure you don’t miss your appointment, try setting a reminder on your phone.

Will I need to use this drug long term?

Vyondys 53 is meant to be used as a long-term treatment. If you and your doctor determine that Vyondys 53 is safe and effective for you, you’ll likely take it long term.

Vyondys 53 can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Vyondys 53. These lists do not include all possible side effects.

For more information about the possible side effects of Vyondys 53, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Vyondys 53, you can do so through MedWatch.

Mild side effects

Mild side effects* of Vyondys 53 can include:

  • cough
  • common cold
  • abdominal (belly) pain†
  • falls†
  • fever†
  • headache†
  • nausea and vomiting†

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Vyondys 53. To learn about other mild side effects, talk with your doctor or pharmacist, or view Vyondys 53’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Vyondys 53 aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects* can include:

* For more information about the side effects in this list, see “Side effect details” below.

Side effects in children

For children taking Vyondys 53, side effects are expected to be similar to those seen in adults. For more information, see the lists for mild and serious side effects directly above.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Vyondys 53. In clinical trials, it’s not known how many people taking Vyondys 53 may have had an allergic reaction.

Symptoms of a mild allergic reaction can include:

  • rash
  • itchiness
  • flushing (warmth, swelling, or redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing
  • inflammation (swelling) that leads to exfoliative dermatitis (skin shedding)

If you experience an allergic reaction while getting a Vyondys 53 infusion, your doctor will treat your reaction. They may decide to give you your next infusion over a longer period of time. Or they may decide to stop your Vyondys 53 treatment.

Call your doctor right away if you have an allergic reaction after getting your Vyondys 53 infusion, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Kidney damage

Although rare, it’s possible that taking Vyondys 53 could cause kidney damage.

This side effect didn’t occur in people taking the drug in clinical trials. However, kidney damage has occurred in people taking other drugs similar to Vyondys 53. Also, kidney damage was observed when Vyondys 53 was given to young rats in animal studies. But, it’s important to note that animal studies don’t always predict what will happen in humans.

Before you start taking Vyondys 53, your doctor will check your kidney function by testing your urine. And during your treatment, your doctor will use two tests to monitor your kidney health. They’ll order a monthly urine test, and you’ll also need to have a certain blood test done every 3 months. These tests will help your doctor determine whether it’s safe for you to continue taking Vyondys 53.

If you have questions about your kidney health while taking Vyondys 53, talk with your doctor.

Headache

Using Vyondys 53 could cause headache. In clinical trials:

  • 41% of people who received Vyondys 53 experienced headache
  • 10% of people who received a placebo (a treatment with no active drug) experienced headache

If you experience headache while taking Vyondys 53, talk with your doctor. They may recommend ways to relieve this side effect. If headaches become too bothersome, they may have you switch to a different treatment.

Fever

Vyondys 53 may cause fever in some people. In clinical trials:

  • 41% of people who received Vyondys 53 had a fever
  • 14% of people who received a placebo (a treatment with no active drug) had a fever

If you experience fever while taking Vyondys 53, call your doctor. Because fever may also be a sign of a more serious allergic reaction to the drug, your doctor will determine whether you should continue using Vyondys 53.

Fall risk

Taking Vyondys 53 could raise the risk for falls in some people. In clinical studies:

  • 29% of people who received Vyondys 53 experienced a fall
  • 19% of people who received a placebo (a treatment with no active drug) experienced a fall

If you’re concerned about the fall risk during your treatment with Vyondys 53, talk with your doctor. They may be able to recommend ways to make your home safer. Or they may suggest other treatment options for your condition.

Abdominal pain

It’s possible that taking Vyondys 53 could cause abdominal (belly) pain. In clinical studies:

  • 27% of people who received Vyondys 53 had belly pain
  • 10% of people who received a placebo (a treatment with no active drug) had belly pain

If you experience belly pain while taking Vyondys 53, talk with your doctor. They may recommend ways to relieve this side effect. If this pain becomes too bothersome, your doctor may have you switch to another treatment.

Nausea and vomiting

Nausea and vomiting are two side effects that can occur when using Vyondys 53.

In clinical studies:

  • 20% of people taking Vyondys 53 reported nausea, and 27% reported vomiting
  • 10% of people who received a placebo (a treatment with no active drug) reported nausea, and 19% reported vomiting

If you experience nausea or vomiting while taking Vyondys 53, talk with your doctor. They may recommend ways to relieve these side effects. If your nausea or vomiting becomes bothersome enough, your doctor may have you switch to another treatment.

The Food and Drug Administration (FDA) approves prescription drugs such as Vyondys 53 to treat certain conditions. Vyondys 53 may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Vyondys 53 for Duchenne muscular dystrophy

Vyondys 53 is FDA-approved to treat Duchenne muscular dystrophy (DMD)* in adults and children with a certain gene mutation. (A gene mutation means that a specific gene isn’t working the way it should.)

* For treating DMD, Vyondys 53 received accelerated approval from the FDA. Accelerated approval is based on information from early clinical trials. The FDA’s decision for full approval will be made after additional clinical trials are completed.

About DMD

Muscular dystrophy describes a group of genetic (inherited) disorders that cause a loss of muscle mass. This loss of muscle mass is progressive, which means it gets worse over time.

DMD is the most common type of muscular dystrophy. People with DMD are missing (or don’t have enough of) a protein called dystrophin, which muscles need to work properly. This lack of dystrophin is caused by a mutation in the dystrophin gene. (A gene mutation means that a specific gene isn’t working the way it should.) Over time, this lack of dystrophin causes muscle weakness and muscle loss.

DMD most commonly affects boys ages 2 to 3 years. In rare cases, it can affect girls.

Because DMD is a progressive disease, symptoms can change over time. Early symptoms of DMD can include:

  • trouble walking, running, or jumping
  • learning disabilities, such as learning to talk later than usual
  • muscle weakness
  • trouble standing, or sitting up
  • waddling gait (moving from side to side when walking)

As time goes on, the following symptoms may begin to appear:

  • breathing problems, including acute respiratory failure
  • heart problems, due to weakened heart muscles
  • lumbar lordosis (excessive inward curve of the lower spine)
  • not being able to walk
  • trouble swallowing, which may lead to using a feeding tube

Currently, there’s no cure for DMD or any type of muscular dystrophy. However, certain treatments may slow muscle loss and relieve symptoms.

Effectiveness for DMD

A clinical study showed that Vyondys 53 may improve dystrophin levels in people with DMD. Dystrophin is a protein that muscles need to work properly. People with DMD are missing this protein (or don’t have enough of it) because of a mutation in the dystrophin gene. (A gene mutation means that a specific gene isn’t working the way it should.)

To take part in this study, people had to take a genetic test to see if Vyondys 53 would work for their DMD. Vyondys 53 only works for people with DMD caused by certain gene mutations. For more information, see the “How Vyondys 53 works” section below.

People in the study received Vyondys 53 infusions once a week. Vyondys 53 wasn’t compared with a placebo (a treatment with no active drug) or other treatments.

Before the study, researchers measured the dystrophin levels of participants. On average, people’s dystrophin levels in the study were 0.1% of the levels found in someone without DMD. After 48 weeks, the researchers measured dystrophin levels again. They found that the average dystrophin levels had increased to 1.02% of levels found in someone without DMD. The average increase in muscle dystrophin was 0.92%.

Vyondys 53 and children

Vyondys 53 is approved to treat DMD in children. Clinical studies of the drug included children, and the results didn’t distinguish between adults and children.

To learn about Vyondys 53’s effectiveness, see the “Effectiveness for DMD” section directly above.

There aren’t any known interactions between Vyondys 53 and alcohol.

Drinking in moderation usually doesn’t cause harm to most people with Duchenne muscular dystrophy (DMD). However, alcohol may cause problems with balance or coordination in some people, which can lead to falls. Because falls are a potential side effect of Vyondys 53, drinking alcohol while taking Vyondys 53 may raise your risk for falls.

Drinking alcohol may also cause nausea, vomiting, and headache. These are all possible side effects of Vyondys 53. Therefore, drinking alcohol while using Vyondys 53 could raise your risk for these side effects.

If you drink alcohol, talk with your doctor about how much may be safe for you to drink during your Vyondys 53 treatment.

Vyondys 53 isn’t known to interact with other medications, supplements, or foods.

However, to help keep yourself safe, talk with your doctor and pharmacist before taking Vyondys 53. Tell them about all prescription, over-the-counter, and other drugs you or your child takes. Also tell them about any vitamins, herbs, and supplements you or your child use. Sharing this information can help you or your child avoid potential interactions.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Other drugs are available that can treat Duchenne muscular dystrophy (DMD). Some may be a better fit for you than others. If you’re interested in finding an alternative to Vyondys 53, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

Examples of other drugs that may be used to treat DMD include:

Vyondys 53 comes as a liquid solution that’s given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. The infusion is given by your doctor or other healthcare provider. Typically, the infusion will last 35 to 60 minutes.

Some people may experience an allergic reaction after a Vyondys 53 infusion. (To learn more, see “Allergic reaction” under “Vyondys 53 side effects” above.)

If you have an allergic reaction during your infusion, your healthcare provider will treat it. If you experience any of the symptoms above after your Vyondys infusion, call your doctor right away or seek immediate medical care.

When it’s given

You’ll typically receive Vyondys 53 once a week as an intravenous infusion. The infusion is given by your doctor or other healthcare provider. You’ll likely receive this infusion at the doctor’s office or an infusion clinic. In some cases, you may get the infusion at home from a healthcare provider.

It’s important to keep your appointment for your Vyondys 53 infusion. If you miss your appointment, call your doctor’s office right away to reschedule.

To help make sure you don’t miss your appointment, try setting a reminder on your phone.

Vyondys 53 is FDA-approved to treat Duchenne muscular dystrophy (DMD) in adults and children with a certain gene mutation. (A gene mutation means that a specific gene isn’t working the way it should.)

About DMD

Muscular dystrophy describes a group of genetic (inherited) disorders that cause a loss of muscle mass. This loss of muscle mass is progressive, which means it gets worse over time.

DMD is the most common type of muscular dystrophy. Over time, DMD can cause muscle weakness and muscle loss.

DMD most commonly affects boys ages 2 to 3 years. In rare cases, it can affect girls.

Currently, there’s no cure for DMD or any type of muscular dystrophy. However, certain treatments may slow muscle loss and relieve symptoms.

What Vyondys 53 does

People with DMD are missing (or don’t have enough of) a certain protein called dystrophin, which muscles need to work properly. The lack of dystrophin is caused by a mutation in the dystrophin gene. (A gene mutation means that a specific gene isn’t working the way it should.)

With DMD, the most common mutation is having one or more missing exons. An exon is a part of a gene and provides instructions for making proteins. Missing exons cause errors in a gene’s instructions for making dystrophin. This causes someone to have a form of dystrophin that doesn’t work properly, or they may not have any dystrophin at all.

Vyondys 53 works by helping your body “skip” these missing exons while it reads the genetic instructions for making dystrophin. This allows your body to make a different but effective form of dystrophin. Vyondys 53 only works for people whose DMD can be treated by skipping a particular exon called exon 53. Before prescribing Vyondys 53, your doctor will order a genetic test for you. This test will check if your DMD can be treated by skipping exon 53.

How long does it take to work?

It’s not known how long it takes Vyondys to start improving dystrophin levels. Dystrophin is a protein that muscles need to work properly. People with DMD are missing this protein or don’t have enough of it.

In a clinical study of Vyondys 53, dystrophin levels weren’t measured until after 48 weeks of taking Vyondys 53. Researchers found that the average dystrophin levels had increased to 1.02% of levels found in someone without DMD. The average increase in muscle dystrophin was 0.92%.

Because of how the drug works and the condition it treats, you aren’t likely to notice Vyondys 53 working in your body. If you have questions about how Vyondys 53 works, talk with your doctor.

It isn’t known if it’s safe to take Vyondys 53 while pregnant. This is because golodirsen, the active drug in Vyondys 53, hasn’t been studied during pregnancy.

If you’re pregnant or planning a pregnancy, talk with your doctor about the risks and benefits of using Vyondys 53.

It’s not known if Vyondys 53 is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Vyondys 53.

For more information about taking Vyondys 53 during pregnancy, see the “Vyondys 53 and pregnancy” section above.

It’s unknown whether it’s safe to take Vyondys 53 while breastfeeding.

Golodirsen, the active drug in Vyondys 53, hasn’t been studied in connection with breastfeeding. Therefore, it’s not known if golodirsen could cause side effects in a breastfed child.

If you’re currently breastfeeding or planning to breastfeed, talk with your doctor about the risks and benefits of using Vyondys 53.

Here are answers to some frequently asked questions about Vyondys 53.

Does Vyondys 53 cure Duchenne muscular dystrophy?

No, Vyondys 53 isn’t a cure for Duchenne muscular dystrophy (DMD). Currently, there isn’t a known cure for DMD (or any type of muscular dystrophy).

However, clinical trials have shown that Vyondys 53 can increase dystrophin levels in people with DMD. Dystrophin is a protein that muscles need to work properly. People with DMD are missing this protein or don’t have enough of it.

If you have questions about treatment options for DMD, talk with your doctor.

Will I need to have any lab tests before or during treatment with Vyondys 53?

Yes. You’ll need to have certain lab tests both before and during your Vyondys 53 treatment.

Before taking Vyondys 53, your doctor will order a genetic test to determine whether this drug is right for you. Vyondys 53 is used in people with DMD that can be treated by “skipping” exon 53. For more information on how Vyondys 53 works, including an explanation of exons and exon skipping, see the “How Vyondys 53 works” section above.

Before you start taking Vyondys 53, your doctor will check your kidney function by testing your urine. And during your treatment, your doctor will use two tests to monitor your kidney health. They’ll order a monthly urine test, and you’ll also need to have a certain blood test done every 3 months. These tests will help your doctor determine whether it’s safe for you to continue taking Vyondys 53.

If you have certain side effects while taking Vyondys 53, your doctor may order additional tests to check if you’re experiencing a reaction to the drug. If you have questions about lab tests related to your Vyondys 53 treatment, talk with your doctor.

Can I take Vyondys 53 If I have kidney problems?

It depends. When the drug was tested in people without Duchenne muscular dystrophy (DMD) but who had kidney problems, researchers found the drug wasn’t cleared from the body as quickly. However, Vyondys 53 hasn’t been studied in people with both DMD and kidney problems. Therefore, it’s not known whether people with kidney problems need a different dose of Vyondys 53.

In animal studies, Vyondys 53 caused kidney damage in some rats. It’s important to note that the doses used in these studies were much higher than those used in people with DMD. In addition, animal studies don’t always predict what will happen in humans.

Before you start taking Vyondys 53, your doctor will check your kidney function by testing your urine. And during your treatment, your doctor will use two tests to monitor your kidney health. They’ll order a monthly urine test, and you’ll also need to have a certain blood test done every 3 months. These tests will help your doctor determine whether it’s safe for you to continue taking Vyondys 53.

If you have questions about your kidney health while taking Vyondys 53, talk with your doctor.

I see that Vyondys 53 is called an “orphan drug.” What’s an “orphan drug?”

Vyondys 53 has received orphan drug status (sometimes called “orphan designation” or “orphan status”) from the Food and Drug Administration (FDA).

The FDA gives this special status to medications that treat rare conditions. This is done in hopes of encouraging more research into conditions that currently don’t have many (or any) treatment options.

Pharmaceutical companies must request orphan drug status for a medication from the FDA. They have to conduct trials to prove the medication is safe and effective. In return, they may receive certain tax credits to help offset the costs of clinical testing.

In addition to being an orphan drug, Vyondys 53 received FDA approval under its accelerated approval laws. To learn more, see “FDA approval” in the “What is Vyondys 53?” section above.

Is Vyondys 53 similar to Exondys 51?

Yes. Vyondys 53 is similar to Exondys 51, but these medications do have some differences.

Vyondys 53 and Exondys 51 are both FDA-approved to treat Duchenne muscular dystrophy (DMD), but who can take these drugs differs. Exondys 51 is used in people with DMD that can be treated by “skipping” exon 51. Vyondys 53 is used in people with DMD that can be treated by
“skipping” exon 53. For more information on exons and exon skipping, see the “How Vyondys 53 works” section above.

Both Vyondys 53 and Exondys 51 are given as an intravenous (IV) infusion, which is an injection into your vein over a period of time. The infusion is given by your doctor or other healthcare provider. Both drugs also belong to a drug class called antisense oligonucleotides. (A drug class is a group of medications that work in a similar way.)

Both Vyondys 53 and Exondys 51 are approved under the FDA’s accelerated approval regulations. For more information on accelerated approval, see the “What is Vyondys 53?” section above.

One important difference between these drugs is the risk of kidney damage as a side effect. If you take Vyondys 53, you’ll need to get certain tests done during your treatment to check your kidney function. This is because the drug could possibly cause kidney damage. The risk of kidney damage is lower with Exondys 51 than with Vyondys 53. Some people may not need to have these tests while taking Exondys 51.

If you have questions about how Exondys 51 and Vyondys 53 compare, talk with your doctor.

Before taking Vyondys 53, talk with your doctor about your health history. Vyondys 53 may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Kidney problems. Based on animal studies, there’s a possible risk of kidney problems in people taking Vyondys 53. It’s important to note that the doses used in the animal studies were much higher than those used to treat people with Duchenne muscular dystrophy (DMD). It’s not known if Vyondys 53 can cause kidney problems in humans. However, tell your doctor about any history of kidney problems before you start treatment. See “Kidney damage” under the “Vyondys 53 side effects” section above to learn more.
  • Allergic reaction. If you’ve had an allergic reaction to Vyondys 53 or any of its ingredients, you shouldn’t take Vyondys 53. Ask your doctor about other medications that may be better options for you.
  • Pregnancy. It isn’t known if Vyondys 53 is safe to take while pregnant. For more information, see the “Vyondys 53 and pregnancy” section above.
  • Breastfeeding. It isn’t known if Vyondys 53 is safe to take while breastfeeding. For more information, see the “Vyondys 53 and breastfeeding” section above.

Note: For more information about the potential negative effects of Vyondys 53, see the “Vyondys 53 side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.