Tafamidis 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.

Tafamidis 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.

Tafamidis may also be used for purposes not listed in this medication guide.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Vyndaqel and Vyndamax are not equivalent medicines and may not have the same dosing schedule.

Take either Vyndaqel or 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 tafamidis 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 meglumine (Vyndaqel): 80 mg orally once a day (Four 20 mg capsules/day)
OR
Tafamidis (Vyndamax): 61 mg orally once a day (One 61 mg capsule/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.

Tell your doctor if you have ever had:

• 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 tafamidis at 1-800-438-1985.

You should not breastfeed while using tafamidis.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect 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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.