Tafamidis (ta-FAM-id-is)

Treats cardiomyopathy (enlarged and thickened heart) to reduce death and hospitalization related to heart problems.

Brand Name(s):

Vyndamax, Vyndaqel

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid Filled Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule whole. Do not cut, crush, or chew it.
• Use only the brand of this medicine that your doctor prescribed. Vyndamax™ and Vyndaqel® have different dosage strengths.
• Patients who use this medicine may register for the Transthyretin Amyloidosis Outcome Survey (THAOS), which may be used to inform and educate patients and healthcare professionals about the disease and its management. This may involve long-term follow-up.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tafamidis works. Tell your doctor if you are using imatinib, methotrexate, or rosuvastatin.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed during treatment with this medicine.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice other side effects that you think are caused by this medicine, tell your doctor

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