Vyndamax

Vyndamax is an oral prescription medicine that may be used to reduce death or hospitalization related to heart problems in adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). Vyndamax is a transthyretin stabilizer.

Vyndamax works by stabilizing abnormal transthyretin, a protein associated with ATTR-CM. This mechanism of action of Vyndamax prevents the formation of harmful amyloid protein deposits in the heart, slowing disease progression.

Vyndamax was FDA approved on May 3, 2019. There is no Vyndamax generic.

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, serious side effects, or contraindications for Vyndamax.

Before taking Vyndamax, 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

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

Breastfeeding

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

There are no side effects of Vyndamax listed in the Vyndamax Package Insert, but the most common side effect reported post-marketing has been diarrhea.

• No additional lab testing or monitoring is required in people taking Vyndamax.
• 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 Vyndamax exactly as your healthcare provider tells you to take it.

Take Vyndamax 1 time a day. Try to take it at around the same time each day.

• The usual dosage is 61 mg (1 capsule) once a day.
• Your healthcare provider cannot substitute Vyndamax for Vyndaqel 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 capsule whole. Do not crush or cut.

If you miss a dose of Vyndamax, 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 Vyndamax works, and Vyndamax 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 Vyndamax capsules at room temperature between 68°F to 77°F (20°C to 25°C).

Keep out of the reach of children.

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. manufactures Vyndamax.