Vyndaqel

tafamidis

Used for Cardiomyopathy, Heart Failure

Vyndaqel (tafamidis) is a medication taken by mouth used for a rare type of heart disease called transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM). It's available as two different brand names and is taken once per day.

Reviewed by:

Robert Chad Hakim, PharmD, BCCCP

Cydnee Ng, PharmD

Last reviewed on February 7, 2022

What is Vyndaqel (tafamidis)?

What is Vyndaqel (tafamidis) used for?

Transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM, a rare heart muscle disease)

How Vyndaqel (tafamidis) works

Vyndaqel (tafamidis) is a transthyretin (TTR) stabilizer. It works by attaching to a protein in your body called transthyretin. This slows protein breakdown and buildup in the heart walls, which makes it easier for the heart to pump blood to the rest of your body.

Drug facts

Common Brands	Vyndaqel, Vyndamax
Drug Class	TTR stabilizer
Controlled Substance Classification	Not a controlled medication
Generic Status	No lower-cost generic available
Availability	Prescription only

Common Brands

Vyndaqel, Vyndamax

Drug Class

TTR stabilizer

Controlled Substance Classification

Not a controlled medication

Generic Status

No lower-cost generic available

Availability

Prescription only

Side effects of Vyndaqel (tafamidis)

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

The following side effects listed in the supplemental appendix of a major clinical study were similar in people taking Vyndaqel (tafamidis) and people taking placebo. Side effects were generally mild to moderate in severity.

Bone, muscle, or joint problems (49%)
Injury (41%)
Skin problems (29%)
Heart failure (15-29%)
Falls (27%)
Mental health problems (24%)
Atrial fibrillation (heart rhythm problem, 19%)
Shortness of breath (19%)
Swelling of the hands, feet, or ankles (18%)
Tiredness (17%)
Dizziness (16%)
Eye problems (16%)
Constipation (15%)
Reproductive or breast problems (15%)

Less Common Side Effects

Nausea
Diarrhea
Cough
Urinary tract infection (UTI)
Kidney problems
Ear problems
Blood problems
Gout

Source: DailyMed

Pros and cons of Vyndaqel (tafamidis)

Pros

The first once-daily, oral treatment for ATTR-CM
Can help lower chance of hospitalizations and death in people with ATTR-CM
Can be taken with or without food
Manufacturer financial assistance available

Cons

Need to take four capsules for one dose of Vyndaqel (tafamidis)
Available as brand names only, which can be very expensive
Not recommended for use during pregnancy

Pharmacist tips for Vyndaqel (tafamidis)

Vyndaqel and Vyndamax aren't equal to each other and can't be switched out for one another. Make sure you know which brand of Vyndaqel (tafamidis) you have to avoid taking the wrong dose.
The dose of Vyndaqel is 80 mg by mouth once per day, which means you'll need to take four 20 mg capsules for one dose.
Swallow the capsules whole. Don't crush or cut the capsules.
Take Vyndaqel (tafamidis) with or without food. Food won't affect how well the medication works.
It's recommended you participate in a registry called the Transthyretin Amyloidosis Outcome Survey (THAOS) when you start taking Vyndaqel (tafamidis). This registry will follow up with you during treatment to see how you're doing. For more information, visit [this website](https://clinicaltrials.gov.

Common questions about Vyndaqel

Transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM) is a rare type of heart muscle disease. Amyloidosis is a group of diseases caused by a buildup of proteins called amyloid in your body's organs. This causes your organs to not work properly. ATTR-CM is a type of amyloidosis that's caused by buildup of a protein called transthyretin on the walls of your heart muscle. This causes your heart walls to become stiff and unable to relax, fill with blood, and pump blood to the rest of your body properly. This can lead to heart failure, which can look like tiredness, shortness of breath, coughing or wheezing, swelling in the feet or ankles, or stomach bloating. Vyndaqel helps with ATTR-CM by attaching to transthyretin to prevent building up in your heart.

The difference between Vyndaqel and Vyndamax is the strength of tafamidis in each capsule and the dose of each brand medication, which affects how they're taken. Vyndaqel comes as 20 mg capsules, but the dose of Vyndaqel is 80 mg once per day. This means that you'll need to take 4 capsules of Vyndaqel for each dose. On the other hand, Vyndamax comes as 61 mg capsules, and the dose of Vyndamax is 61 mg once per day. This means that you'll only need to take 1 capsule of Vyndamax for each dose. This makes Vyndamax more convenient to take for some people compared to Vyndaqel. Both brands aren't equal to each other and therefore can't be switched out for each other. Make sure you know which brand of Vyndaqel you have to avoid taking the wrong dose.

It's not known if Vyndaqel is safe or if it works well in children younger than 18 years old. Symptoms of ATTR-CM can start to appear as early as age 20 (in some people with the genetic version of this heart disease) or as late as after age 65. If you or your child starts to show symptoms of ATTR-CM before the age of 18, speak to your or your child's provider about other options.

Vyndaqel isn't recommended for use in pregnant women because of the potential to cause harm to unborn babies. While there haven't been enough studies in pregnant women, animal studies have shown harm to unborn babies, although this was at doses 9 times higher than the usual dose for humans. To be safe, women and men of reproductive potential should consider careful pregnancy planning and prevention before starting Vyndaqel. If you become pregnant or think you've become pregnant while taking Vyndaqel, it's recommended to let your provider know and contact the manufacturer (Pfizer) at 1-800-438-1985.