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Tafamidis

Pronunciation: TAH-fam-eye-dis
Generic name: tafamidis
Brand names: Vyndaqel, Vyndamax
Dosage form: oral capsule
Drug class: Transthyretin stabilizers

Medically reviewed by Carmen Pope, BPharm. Last updated on May 7, 2024.

What is tafamidis?

Tafamidis is a transthyretin stabilizer that may be given to reduce death or hospitalization caused by heart problems in adults with cardiomyopathy (damage of the heart muscle) caused by wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).

Tafamidis works by attaching to the transthyretin protein, which is an important protein primarily produced by the liver, but also in small amounts by the outer lining of the brain and retina. TTR carries the thyroid hormone thyroxine and retinol (vitamin A) throughout the body. Tafamidis stabilizes TTR, helping it to stay together, and slowing the breakdown and build-up of dangerous deposits, which can help slow the progression of ATTR-CM.

Tafamidis is available as Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) which were both FDA approved on May 3, 2019.

The difference between Vyndaqel and Vyndamax is their form of tafamidis. Vyndaqel has the micronized meglumine salt, while Vyndamax has the free acid form. Vyndamax is designed for convenience, with one capsule taken daily, while Vyndaqel requires four capsules daily. No generic versions are available for either.

Tafamidis side effects

The rate of side effects reported during clinical trials of tafamidis was similar to placebo (an inactive treatment). Diarrhea has been reported as a possible side effect during post-approval use.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tafamidis side effects (more detail)

Warnings

There are no warnings or contraindications for tafamidis.

Before taking

Before taking tafamidis, tell your healthcare provider about all your medical conditions, including if you:

Pregnancy

Tafamidis may harm your unborn baby. You may need to take a pregnancy test before starting treatment and use effective contraception throughout treatment. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with tafamidis. You may also report your pregnancy by calling the Pfizer reporting line at 1-800-438-1985.

Breastfeeding

It is not known if tafamidis passes into your breast milk. You should not breastfeed during treatment with tafamidis. Talk to your healthcare provider about the best way to feed your baby during treatment.

Tafamidis pregnancy and breastfeeding warnings (more detail)

How do I take tafamidis?

Take tafamidis exactly as your healthcare provider tells you to take it.

Tafamidis is usually taken once a day. Try to take it at around the same time each day.

Swallow the capsule(s) whole. Do not crush or cut.

What happens if I miss a dose?

If you miss a dose of tafamidis, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regularly scheduled time. Do not take 2 doses at the same time.

What other drugs will affect tafamidis?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect the way tafamidis works, and tafamidis may affect how some medicines work. Especially tell your healthcare provider if you take:

Know the medicines you take. Keep a list of all your medicines. Show them to your healthcare provider or pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.

Tafamidis drug interactions (more detail)

Storage

Store Vyndaqel and Vyndamax capsules at room temperature between 68°F to 77°F (20°C to 25°C).

Keep out of the reach of children.

Tafamidis ingredients

Vyndaqel

Active ingredient: tafamidis meglumine 20 mg

Inactive ingredients: ammonium hydroxide 28%, brilliant blue FCF, carmine, gelatin, glycerin, iron oxide (yellow), polyethylene glycol 400, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, sorbitan monooleate, sorbitol, and titanium dioxide

Vyndamax

Active ingredient: tafamidis 61 mg

Inactive ingredients: ammonium hydroxide 28%, butylated hydroxytoluene, gelatin, glycerin, iron oxide (red), polyethylene glycol 400, polysorbate 20, povidone (K-value 90), polyvinyl acetate phthalate, propylene glycol, sorbitol, and titanium dioxide

Manufacturer

Pfizer Inc.

Popular FAQ

Vyndamax, when compared to a placebo, was shown to improve the survival rates (71% vs. 57%, respectively) for patients with wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) over a 30-month long clinical study. Quality-of-life measurements improved as early as 6 months. Continue reading

It takes at least 6 months for Vyndaqel to start working and it may take up to 18 months for the full effects to be seen, but these persist for at least 30 months. There was significantly less decline in functional capacity (as measured by a 6-minute walk test [6MWT]) and health status (as measured by the Kansas City Cardiomyopathy Questionnaire-Overall Summary [KCCQ-OS]) with Vyndaqel at 6 months than placebo. It may take at least 18 months before Vyndaqel makes a difference in all cause mortality compared to placebo, but this difference persists and trials have reported a survival rate of 71% in those taking Vyndaqel compared to 57% taking placebo. Those receiving Vyndaqel had 32% less hospitalizations due to heart problems, also statistically significant. Continue reading

References

  1. Tafamidis Package Insert

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer