Vyndamax affects a protein called transthyretin (TTR, made primarily in the liver). Transthyretin-mediated amyloidosis (ATTR) is a condition in which abnormal deposits of TTR protein build-up in many parts of the body, interfering with normal function. A build-up of TTR in the heart can lead to heart failure.

People with hereditary ATTR amyloidosis have a DNA mutation that can be passed from one generation to the next. People with wild-type ATTR amyloidosis do not have abnormal DNA and cannot pass on the condition.

Vyndamax is used in adults with hereditary or wild type ATTR to treat cardiomyopathy (damage of the heart muscle) caused by a build-up of TTR.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Take Vyndamax exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Vyndamax exactly as your doctor has recommended. Avoid medication errors by using only the form and strength your doctor prescribes.

Swallow the capsule whole and do not crush, chew, break, or open it.

You may take Vyndamax with or without food.

Store at room temperature away from moisture and heat. Keep each capsule in the blister pack until you are ready to take a dose.

Usual Adult Dose for Amyloidogenic Transthyretin Amyloidosis:

Tafamidis 61 mg: 1 capsule once a day (61 mg/day)

Comments: Tafamidis and tafamidis meglumine products are not substitutable on a per mg basis.

Use: For the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

To make sure Vyndamax is safe for you, tell your doctor if you have:

• liver disease.

Your name may be listed on a Transthyretin Amyloidosis Outcome Survey registry to track the effects of tafamidis on your condition.

Tafamidis may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

If you become pregnant, tell your doctor or contact the manufacturer of Vyndamax at 1-800-438-1985.

You should not breastfeed while using Vyndamax.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Vyndamax: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

There were no known side effects that happened during treatment with Vyndamax in people with cardiomyopathy of transthyretin-mediated amyloidosis.

Less serious side effects may occur, or you may have none at all.

You may report side effects to FDA at 1-800-FDA-1088.

Other drugs interact with tafamidis, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.