Vyndaqel

Vyndaqel (tafamidis meglumine) 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).

Vyndaqel (tafamidis meglumine) 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. Vyndaqel 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.

Vyndaqel was FDA-approved on May 3, 2019.

The difference between Vyndaqel and Vyndamax is the form of the active ingredient they both contain, tafamidis. Vyndaqel has the micronized tafamidis meglumine salt, while Vyndamax has the free acid form of tafamidis.

Both forms work the same way in the body, but Vyndaqel contains a smaller amount of tafamidis and 4 capsules need to be taken 1 time a day. Vyndamax is taken as 1 capsule, 1 time per day.

• You cannot substitute Vyndamax for Vyndaqel on a mg-to-mg basis. But your healthcare provider can switch you from taking Vyndaqel 80 mg (4 x 20 mg capsules) to taking Vyndamax 61 mg (1 x 61 mg capsule) to reduce the number of pills you take every day.
• Research has shown the side effects of Vyndaqel and Vyndamax are similar.
• Vyndamax capsules are the same size as Vyndaqel capsules.

There are no warnings or contraindications for Vyndaqel.

Before taking Vyndaqel, 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

Vyndaqel 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 Vyndaqel. You may also report your pregnancy by calling the Pfizer reporting line at 1-800-438-1985.

Breastfeeding

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

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

• No additional lab testing or monitoring is required in people taking Vyndaqel.
• As with any medicine, hypersensitivity 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.

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

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

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

• The usual dosage is 80 mg (4 capsules of 20 mg) once a day.
• Your healthcare provider cannot substitute Vyndaqel for Vyndamax on a mg-to-mg basis. But they can switch you from Vyndaqel 80 mg (4 x 20 mg capsules) to Vyndamax 61 mg (1 x 61 mg capsule) to reduce the number of pills you take every day.

Swallow the capsules whole. Do not crush or cut.

If you miss a dose of Vyndaqel, 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 Vyndaqel works, and Vyndaqel 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. Monitor for signs of BCRP substrate-related toxicities and modify the dosage of the substrate if appropriate.

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

Keep out of the reach of children.

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

Pfizer Inc.