Tafamidis

Tafamidis (brand names Vyndaqel and Vyndamax) 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, 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. There is no generic Vyndaqel or Vyndamax.

The difference between Vyndaqel and Vyndamax is their form of tafamidis. Vyndaqel contains the micronized tafamidis meglumine salt, while Vyndamax has the free acid form of tafamidis.

Vyndamax is designed for convenience, with one capsule taken daily, while Vyndaqel requires four capsules daily. No generic versions are available for either.

You cannot substitute Vyndaqel for Vyndamax on a mg-to-mg basis.

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

• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

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.

There are no common side effects reported for tafamidis, but diarrhea has been reported as a possible side effect post-approval.

• People taking tafamidis do not require any additional lab testing or monitoring.
• As with any medicine, hypersensitivity (allergic) reactions are possible. Get emergency medical help if you have signs of an allergic reaction, such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

There are no warnings, contraindications, or serious side effects listed for tafamidis.

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

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.

• The usual dosage of Vyndaqel is 80 mg (4 capsules of 20 mg) once a day.
• The usual dosage of Vyndamax is 61 mg (1 capsule) once a day.
• You cannot substitute Vyndaqel for Vyndamax on a mg-to-mg basis.

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

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.

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:

• medications that are BCRP substrates such as methotrexate, rosuvastatin, or imatinib. Your healthcare provider may need to reduce the dosage of these medications.

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.

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

Keep out of the reach of children.

Tafamidis is only available as Vyndaqel or Vyndamax.

Vyndaqel capsules

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 capsules

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

Pfizer Inc., makes tafamidis under the brand name Vyndaqel and Vyndamax.