Vyndamax and Vyndaqel are brand-name prescription medications. They’re FDA-approved to treat a type of heart condition called cardiomyopathy. The cardiomyopathy must be caused by one of two kinds of a disease known as transthyretin-mediated amyloidosis (ATTR). With ATTR, proteins called transthyretins build up. The two kinds of ATTR involved are:
- Wild-type ATTR. “Wild type” means the condition isn’t genetic, so you haven’t inherited it.
- Hereditary ATTR. This type of ATTR is inherited.
The goal of both Vyndamax and Vyndaqel is to reduce the risk of hospital stays and death due to heart problems.
Drug class and form
Vyndamax contains the active drug tafamidis. Vyndaqel contains the active drug tafamidis meglumine, which is a salt form of tafamidis. Vyndamax and Vyndaqel are absorbed into the body differently, so they have different recommended dosages. They can’t be substituted on a 1:1 basis.
Vyndamax and Vyndaqel belong to a class of medications known as transthyretin stabilizers. (A medication class is a group of medications that work in a similar way.)
Both Vyndamax and Vyndaqel come as capsules that you swallow. You’ll take either drug once a day.
Vyndamax is available in one strength: 61 mg. Vyndaqel is also available in one strength: 20 mg.
FDA approval
The Food and Drug Administration (FDA) approved Vyndamax and Vyndaqel in 2019.
Effectiveness
For information on the effectiveness of Vyndamax and Vyndaqel, see the “Vyndamax and Vyndaqel uses” section below.
Vyndamax and Vyndaqel are available only as brand-name medications. They’re 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.
Vyndamax contains the active drug tafamidis. Vyndaqel contains the active drug tafamidis meglumine, which is a salt form of tafamidis. Vyndamax and Vyndaqel are absorbed into the body differently, so they have different recommended dosages. They can’t be substituted on a 1:1 basis.
Here we look at how Vyndamax and Vyndaqel are alike and different.
Ingredients
Vyndamax contains the active drug tafamidis. Vyndaqel contains the active drug tafamidis meglumine, which is a salt form of tafamidis.
It’s important to note that although the names sound very similar, Vyndamax and Vyndaqel are absorbed into the body differently. So you can’t substitute Vyndamax and Vyndaqel on a 1:1 basis. This means that 1 mg of Vyndamax isn’t equal to 1 mg of Vyndaqel.
Uses
The Food and Drug Administration (FDA) has approved Vyndamax and Vyndaqel to treat a type of heart condition called cardiomyopathy. The cardiomyopathy must be caused by one of two kinds of a disease known as transthyretin-mediated amyloidosis (ATTR). With ATTR, proteins called transthyretins build up. The two kinds of ATTR involved are:
- Wild-type ATTR. “Wild type” means the condition isn’t genetic, so you haven’t inherited it.
- Hereditary ATTR. This type of ATTR is inherited.
The goal of Vyndamax and Vyndaqel is to reduce the risk of hospital stays and death due to heart problems caused by ATTR.
Drug forms and administration
Vyndamax and Vyndaqel both come as capsules that you swallow. You’ll take either of them once a day.
Effectiveness
The only condition both Vyndamax and Vyndaqel are used to treat is cardiomyopathy that’s caused by either wild-type or hereditary ATTR.
The FDA approved the two drugs based on a clinical study that looked at the effectiveness of Vyndaqel. Vyndaqel has been shown to reduce the risk of hospital stays and death from heart problems due to ATTR.
People in the study received 20 mg or 80 mg of Vyndaqel or a placebo (drug with no active treatment). The researchers followed the people for 30 months and found that:
- At month 30, 70.5% of people who received either dose of Vyndaqel were still alive, compared with 57.1% of people who received a placebo.
- People who received Vyndaqel had a 32% lower risk of a heart-related hospital stay than people who received a placebo.
Costs
Vyndamax and Vyndaqel are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.
The Food and Drug Administration approved Vyndamax and Vyndaqel based on a clinical study that examined the effectiveness of Vyndaqel. Researchers looked at people with cardiomyopathy (CM) caused by one of two types of transthyretin-mediated amyloidosis (ATTR): wild-type or hereditary. There were no known side effects reported in the study.
This lack of side effects may be because of how the drugs work. In people with ATTR, a protein called transthyretin doesn’t function properly, so the protein becomes unstable. Vyndamax and Vyndaqel specifically bind to and stabilize transthyretin, helping it work correctly. Because the drugs target just this protein and not any others, the drugs are less likely to cause side effects.
The Food and Drug Administration (FDA) approves prescription drugs such as Vyndamax and Vyndaqel to treat certain conditions.
Vyndamax and Vyndaqel for cardiomyopathy caused by ATTR amyloidosis
Vyndamax and Vyndaqel are FDA-approved to treat a type of heart condition called cardiomyopathy (CM). This condition prevents your heart muscles from working normally.
The CM must be caused by one of two kinds of a disease known as transthyretin-mediated amyloidosis (ATTR). With amyloidosis, proteins clump together and can damage organs such as the heart. ATTR involves proteins called transthyretins.
The two kinds of ATTR involved are:
- Wild-type ATTR. “Wild type” means the condition isn’t genetic, so you haven’t inherited it.
- Hereditary ATTR. This type of ATTR is inherited.
The goal of Vyndamax and Vyndaqel is to reduce the risk of hospital stays and death due to ATTR cardiomyopathy (ATTR-CM).
Whether you have wild-type or hereditary ATTR doesn’t affect how you’re treated or how Vyndamax or Vyndaqel work. Both drugs treat ATTR-CM by attaching to the defective transthyretin proteins and stabilizing them. This helps transthyretins function properly and prevent them from sticking to other transthyretins to form clumps.
Effectiveness for cardiomyopathy caused by ATTR amyloidosis
A clinical study looked at people with cardiomyopathy caused by wild-type or hereditary ATTR. Vyndamax and Vyndaqel were proven to reduce the risk of hospital stays and death due to heart problems.
People in the study received 20 mg or 80 mg of Vyndaqel or a placebo (drug with no active treatment). The researchers followed the people for 30 months and found the following:
- At month 30, 70.5% of people who received either dose of Vyndaqel were still alive, compared with 57.1% of people who received a placebo.
- People who received Vyndaqel had a 32% lower risk of a heart-related hospital stay than people who received a placebo.
- People who received Vyndaqel also had 30% lower risk of death than people who received a placebo.
Vyndamax and Vyndaqel: Use in children
It’s not known if Vyndamax and Vyndaqel are safe to use in children because the drugs weren’t studied in children. Vyndamax and Vyndaqel are currently approved for use only in adults ages 18 years and older.
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Drug forms and strengths
Vyndamax and Vyndaqel both come as capsules that you swallow.
Vyndamax is available one strength: 61 mg. Vyndaqel is also available in one strength: 20 mg.
Vyndamax dosage for cardiomyopathy caused by ATTR amyloidosis
Vyndamax is used to treat cardiomyopathy (CM) that’s caused by one of two types of a disease known as transthyretin-mediated amyloidosis (ATTR). The two types are wild-type ATTR and hereditary ATTR.*
The dosage of Vyndamax for these uses is 61 mg (one capsule) once a day.
Regardless of whether you have cardiomyopathy caused by wild-type or hereditary ATTR, the treatment is the same. The specific type of ATTR you have doesn’t affect how Vyndamax is used.
* For details, see the “Vyndamax and Vyndaqel uses” section above.
Vyndaqel dosage for cardiomyopathy caused by ATTR amyloidosis
Vyndaqel is used to treat CM that’s caused by one of two types of ATTR. The two types are wild-type ATTR and hereditary ATTR.*
The dosage of Vyndaqel for these uses is 80 mg (four capsules) once a day.
Regardless of whether you have cardiomyopathy caused by wild-type or hereditary ATTR, the treatment is the same. The specific type of ATTR you have doesn’t affect how Vyndaqel is used.
* For details, see the “Vyndamax and Vyndaqel uses” section above.
What if I miss a dose?
If you miss a dose, take it as soon as you remember. Or you can simply wait and take your next dose at your usual time. Keep in mind that you shouldn’t “double” your dose by taking two doses at the same time.
To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.
Will I need to use this drug long term?
Vyndamax and Vyndaqel are meant to be used as long-term treatments. If you and your doctor determine that Vyndamax or Vyndaqel is safe and effective for you, you’ll likely take it long term.
There’s no known interaction between Vyndamax or Vyndaqel and alcohol. If you have questions about consuming alcohol while taking either drug, talk with your doctor.
Vyndamax and Vyndaqel can interact with several other medications.
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.
Vyndamax or Vyndaqel with other medications
Below is a list of medications that can interact with Vyndamax and Vyndaqel. This list doesn’t contain all drugs that may interact with Vyndamax and Vyndaqel.
Before taking Vyndamax or Vyndaqel, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Vyndamax or Vyndaqel with medications that use a certain transport protein
Your body makes special substances called transporters (transport proteins). These proteins help move other substances in the body, including medications.
Vyndamax and Vyndaqel inhibit one of these transport proteins called breast cancer resistance protein (BCRP). “Inhibit” means keep from working properly.
BCRP helps keep certain medications at safe levels in the body. BCRP also helps prevent these medications from reaching areas of the body where they shouldn’t go, such as the brain.
Vyndamax and Vyndaqel inhibit BCRP, which means that the medications BCRP affects may rise to unsafe levels in your body. And this can increase your risk for side effects from those medications.
Medications that may be affected by Vyndamax or Vyndaqel inhibiting BCRP include:
If you’re taking any of these medications, tell your doctor before you use Vyndamax or Vyndaqel. Your doctor may adjust your doses of these drugs. Or they may decide to use different medications to treat your conditions.
Vyndamax or Vyndaqel with herbs and supplements
There aren’t any herbs or supplements that have been specifically reported to interact with Vyndamax or Vyndaqel. However, you should still check with your doctor or pharmacist before using any of these products while taking Vyndamax or Vyndaqel.
Vyndamax or Vyndaqel with foods
There aren’t any foods that have been specifically reported to interact with Vyndamax or Vyndaqel. If you have any questions about eating certain foods with Vyndamax or Vyndaqel, talk with your doctor.
As with all medications, the cost of Vyndamax and Vyndaqel can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Before approving coverage for Vyndamax or Vyndaqel, 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 to get prior authorization for Vyndamax or Vyndaqel, contact your insurance company.
Financial and insurance assistance
If you need financial support to pay for Vyndamax or Vyndaqel, or if you need help understanding your insurance coverage, help is available.
Pfizer Inc., the manufacturer of Vyndamax and Vyndaqel, offers a program called VyndaLink. For more information and to find out if you’re eligible for support, call 888-222-8475 or visit the program website.
Generic version
Vyndamax and Vyndaqel aren’t 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.
Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Vyndamax or Vyndaqel, 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 use is when a drug that’s approved to treat one condition is used to treat a different condition.
Alternatives for cardiomyopathy caused by ATTR amyloidosis
Vyndamax and Vyndaqel are used to treat cardiomyopathy (CM) that’s caused by one of two types of a disease called transthyretin-mediated amyloidosis (ATTR). The two types are wild-type ATTR and hereditary ATTR.*
Regardless of whether you have cardiomyopathy caused by wild-type or hereditary ATTR, the treatment is the same. The specific type of ATTR you have doesn’t affect how Vyndamax and Vyndaqel are used.
Currently, Vyndamax and Vyndagel are the only medications approved for treating ATTR-CM. However, the following medications may also be used off-label for ATTR-CM:
- diflunisal
- tolcapone (Tasmar)
- a combination of doxycycline and tauroursodeoxycholic acid (TUDCA)
There are other medications used for people with ATTR-CM who also have symptoms of heart failure. But these drugs treat only symptoms of ATTR-CM and heart failure. The medications don’t treat ATTR-CM itself, and they don’t have any effect on the cause of the condition.
Examples of medications that may be used to help manage symptoms of ATTR-CM and heart failure include:
- spironolactone (Aldactone)
- eplerenone (Inspra)
- furosemide (Lasix)
- torsemide (Demadex)
- bumetanide (Bumex)
* For details, see the “Vyndamax and Vyndaqel uses” section above.
You should take Vyndamax or Vyndaqel according to your doctor’s or healthcare provider’s instructions.
Vyndamax and Vyndaqel both come as capsules that you swallow.
When to take
You should take your Vyndamax or Vyndaqel dose once a day.
To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.
Taking Vyndamax and Vyndaqel with food
You can take Vyndamax or Vyndaqel with or without food.
Can Vyndamax and Vyndaqel be crushed, split, or chewed?
No, you shouldn’t crush, split, or chew Vyndamax or Vyndaqel. You should swallow the capsules whole.
Vyndamax and Vyndaqel are used treat a type of heart condition called cardiomyopathy (CM), which prevents your heart muscles from working normally.
The CM must be caused by one of two kinds of a disease known as transthyretin-mediated amyloidosis (ATTR). With ATTR, proteins known as transthyretins don’t function properly.
The two kinds of ATTR involved are:
- Hereditary ATTR. This type of ATTR is inherited. If you have hereditary ATTR, you have a mutated (faulty) gene. This causes your body to make a defective and unstable form of transthyretin.
- Wild-type ATTR. “Wild type” means the condition isn’t genetic, so you haven’t inherited it. If you have wild-type ATTR, you don’t have the genetic mutation mentioned above. With this condition, transthyretin becomes unstable over time as you age.
Normally, the transthyretin protein helps move substances such as thyroxine (a kind of hormone) and vitamin A to where they need to be in the body. With ATTR, defective transthyretin proteins clump together, forming what are known as amyloid fibrils.
Your body can’t get rid of these amyloid fibrils like it would usually remove healthy proteins. So over time, these amyloid fibrils travel in your blood and can form deposits in your organs, including your heart. When these fibrils build up in the heart, they cause your heart muscle to become thick and stiff. This weakens the heart and makes it hard for it to properly pump blood throughout your body.
Amyloid fibrils from ATTR can result in CM. The condition is abbreviated as ATTR-CM.
What Vyndamax and Vyndaqel do
Vyndamax and Vyndaqel help treat ATTR-CM by attaching to the defective transthyretin protein and stabilizing it. This helps transthyretin function properly and prevent it from sticking with other proteins to form amyloid fibrils.
How long do they take to work?
Vyndamax and Vyndaqel begin working shortly after you start using them. However, it may take several months before you notice the effects.
In a clinical study of people who took Vyndaqel, cardiomyopathy symptoms like shortness of breath started to ease about 6 months after they started taking the drug.
Vyndamax and Vyndaqel may cause harm to a developing fetus when taken during pregnancy. This is based on animal studies in which the animals were given a dose nine times higher than the maximum recommended dose in people.
However, it’s important to note that animal studies don’t always predict what will happen in people. And currently, there isn’t enough information on how Vyndamax and Vyndaqel affect pregnancy in humans.
If you’re pregnant or planning on becoming pregnant, talk to your doctor before taking Vyndamax or Vyndaqel. They can review the best treatment options for you.
Based on animal studies, Vyndamax and Vyndaqel may cause harm to a developing fetus and may not be safe to take during pregnancy. So if you’re sexually active and you or your partner can become pregnant, speak with your doctor. The manufacturer of the drugs recommends that you talk with your doctor about your birth control options before using Vyndamax or Vyndaqel.
For more information about taking Vyndamax or Vyndaqel during pregnancy, see the “Vyndamax and Vyndaqel: Pregnancy” section above.
You shouldn’t breastfeed while taking Vyndamax or Vyndaqel.
Although it’s known that the drugs pass into breast milk in animals, there isn’t information on whether the drugs pass into human breast milk. And animal studies don’t always predict what will happen in people. It’s also unknown what effects Vyndamax and Vyndaqel could have on a breastfed child, if any.
If you’re breastfeeding or planning to breastfeed, talk with your doctor before taking Vyndamax or Vyndaqel. They can recommend healthy ways to feed your child and the right treatment for you.
Here are answers to some frequently asked questions about Vyndamax and Vyndaqel.
Do Vyndamax and Vyndaqel treat nerve damage caused by ATTR amyloidosis?
Vyndamax and Vyndaqel aren’t approved in the United States to treat nerve damage caused by transthyretin-mediated amyloidosis (ATTR). This condition is called transthyretin amyloid polyneuropathy.
Vyndaqel is approved in more than 40 countries for the treatment of nerve damage caused by ATTR. Vyndamax, on the other hand, isn’t.
If you have questions about treatments for nerve damage caused by ATTR, talk with your doctor.
What is the difference between Vyndamax and Vyndaqel?
Vyndamax contains the active drug tafamidis. Vyndaqel contains the active drug tafamidis meglumine, which is a salt form of tafamidis.
It’s important to note that although the names sound very similar, Vyndamax and Vyndaqel are absorbed into the body differently. So you can’t substitute Vyndamax and Vyndaqel on a 1:1 basis. This means that 1 mg of Vyndamax isn’t equal to 1 mg of Vyndaqel.
For more information on differences between Vyndamax and Vyndaqel, see the section above titled “Vyndamax vs. Vyndaqel.”
Why does my doctor want me to sign up for a Vyndamax or Vyndaqel registry?
Your doctor may have asked you to sign up for the Transthyretin Amyloidosis Outcomes Survey (THAOS). This is an international disease registry that helps researchers learn more about ATTR and the impact different treatments have on ATTR. These treatments include Vyndamax and Vyndaqel.
For more about THAOS, talk with your doctor.
Will Vyndamax or Vyndaqel cure my condition?
No. There aren’t any cures for ATTR cardiomyopathy (ATTR-CM), so Vyndamax and Vyndaqel won’t cure your condition. But these medications may help you live longer, help keep you out of the hospital, and help relieve symptoms of ATTR-CM.
For more information on how Vyndamax and Vyndaqel treat ATTR-CM, talk with your doctor.
This drug comes with several precautions. Before taking Vyndamax or Vyndaqel, talk with your doctor about your health history. Vyndamax or Vyndaqel may not be right for you if you have certain medical conditions or other factors affecting your health. These include:
- Allergic reaction. If you’ve had an allergic reaction to Vyndamax or Vyndaqel or any of their ingredients, you shouldn’t take Vyndamax or Vyndaqel. Ask your doctor what other medications are better options for you.
- Pregnancy. Vyndamax and Vyndaqel may cause harm to a developing fetus. For more information, please see the “Vyndamax and Vyndaqel: Pregnancy” section above.
- Breastfeeding. You shouldn’t breastfeed while taking Vyndamax or Vyndaqel. For more information, please see the “Vyndamax and Vyndaqel: Breastfeeding” section above.
Note: For more information about the potential negative effects of Vyndamax and Vyndaqel, see the “Vyndamax and Vyndaqel side effects” section above.
Do not use more Vyndamax or Vyndaqel than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.
Overdose symptoms
Symptoms of an overdose can include a stye (a tender red bump on the edge of your eyelid).
What to do in case of overdose
If you think you’ve taken too much Vyndamax or Vyndaqel, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.
When you get Vyndamax or Vyndaqel from the pharmacy, the pharmacist will add an expiration date to the label on the bottle or carton. This date is typically 1 year from the date they dispensed the medication.
The expiration date helps guarantee that the medication is effective during this time. The
Storage
How long a medication remains good can depend on many factors, including how and where you store the medication.
You should store Vyndamax and Vyndaqel capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep them in a tightly sealed container away from light. If needed, you can store the drugs at temperatures as low as 59°F (15°C) and as high as 86°F (30°C) for short periods of time. Avoid keeping this medication in areas where it could get damp or wet, such as bathrooms.
Disposal
If you no longer need to take Vyndamax or Vyndaqel and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drugs by accident. It also helps keep the drugs from harming the environment.
This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.
The following information is provided for clinicians and other healthcare professionals.
Indications
Vyndamax and Vyndaqel are approved by the Food and Drug Administration (FDA) to treat adults with cardiomyopathy that is caused by either wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).
Administration
Vyndamax is available in 61-mg capsules, and the recommended dose for ATTR-CM is one capsule by mouth once daily.
Vyndaqel is available in 20-mg capsules. The recommended dose for ATTR-CM is four capsules (80 mg) once daily.
Mechanism of action
Tafamidis selectively binds to and stabilizes transthyretin (TTR) at thyroxine binding sites. This stabilizes TTR and slows the process of dissociating into monomers.
Pharmacokinetics and metabolism
Peak concentrations occur within 4 hours after a dose of tafamidis. Food has no clinically significant effect on pharmacokinetics.
Plasma protein binding was shown to be greater than 99% in vitro, primarily to TTR.
Tafamidis has a mean half-life of approximately 49 hours.
Contraindications
There are no known contraindications to the use of Vyndamax and Vyndaqel.
Storage
Vyndamax and Vyndaqel capsules should be stored at room temperature between 68°F to 77°F (20°C to 25°C). Deviations as low as 59°F (15°C) and as high as 86°F (30°C) are permitted.
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.