What is the most important information I should know about tafamidis?
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.
What is tafamidis?
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.
What should I discuss with my healthcare provider before taking tafamidis?
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.
How should I take tafamidis?
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.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking tafamidis?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of tafamidis?
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.
What other drugs will affect tafamidis?
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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