VYNDAQEL^® OR VYNDAMAX™ (tafamidis meglumine or tafamidis)

17. PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

What is VYNDAQEL and VYNDAMAX?

VYNDAQEL and VYNDAMAX are prescription medicines used to treat adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems.

It is not known if VYNDAQEL and VYNDAMAX are safe and effective in children.

Before taking VYNDAQEL or VYNDAMAX, tell your healthcare provider about all your medical conditions, including if you:

•

have liver problems.

•

are pregnant or plan to become pregnant. VYNDAQEL and VYNDAMAX may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VYNDAQEL or VYNDAMAX. You may also report your pregnancy by calling the Pfizer reporting line at 1-800-438-1985.

•

are breastfeeding or plan to breastfeed. It is not known if VYNDAQEL or VYNDAMAX passes into your breast milk. You should not breastfeed during treatment with VYNDAQEL or VYNDAMAX. Talk to your healthcare provider about the best way to feed your baby during treatment with VYNDAQEL or VYNDAMAX.

Tell your healthcare provider about all the medicines you take including any prescription or over-the-counter medicines, vitamins, and herbal supplements.

How should I take VYNDAQEL or VYNDAMAX?

•

Take either VYNDAQEL or VYNDAMAX exactly as your healthcare provider tells you to.

•

Take either VYNDAQEL or VYNDAMAX capsule(s) 1 time a day.

•

VYNDAQEL or VYNDAMAX capsule(s) should be swallowed whole and not crushed or cut.

•

If you miss a dose, 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.

What are the possible side effects of VYNDAQEL and VYNDAMAX?

Diarrhea has been reported as a possible side effect during treatment with VYNDAQEL or VYNDAMAX in people with cardiomyopathy of transthyretin-mediated amyloidosis.

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

How should I store VYNDAQEL and VYNDAMAX?

•

Store VYNDAQEL and VYNDAMAX capsules at room temperature between 68°F to 77°F (20°C to 25°C).

•

Keep VYNDAQEL and VYNDAMAX and all medicines out of the reach of children.

General information about the safe and effective use of VYNDAQEL and VYNDAMAX.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VYNDAQEL or VYNDAMAX for a condition for which it was not prescribed. Do not give VYNDAQEL or VYNDAMAX to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about VYNDAQEL or VYNDAMAX that is written for healthcare professionals.

What are the ingredients in VYNDAQEL and VYNDAMAX?

LAB-0573-4.0
For more information, go to www.vyndaqel.com or call 1-800-438-1985.

Full Patient Information

17. PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Pregnancy

Report pregnancies to the Pfizer reporting line at 1-800-438-1985. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise females not to breastfeed during treatment with VYNDAQEL or VYNDAMAX [see Use in Specific Populations (8.2)].

This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.

For medical information about VYNDAQEL or VYNDAMAX, please visit www.pfizermedinfo.com or call 1‑800‑438‑1985.

This Patient Information has been approved by the U.S. Food and Drug Administration	Issued: 4/2023
PATIENT INFORMATION
VYNDAQEL® (VIN-duh-kel) (tafamidis meglumine) capsules	VYNDAMAX™ (VIN-dah-max) (tafamidis) capsules
What is VYNDAQEL and VYNDAMAX? VYNDAQEL and VYNDAMAX are prescription medicines used to treat adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems. It is not known if VYNDAQEL and VYNDAMAX are safe and effective in children.
Before taking VYNDAQEL or VYNDAMAX, tell your healthcare provider about all your medical conditions, including if you: • have liver problems. • are pregnant or plan to become pregnant. VYNDAQEL and VYNDAMAX may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VYNDAQEL or VYNDAMAX. You may also report your pregnancy by calling the Pfizer reporting line at 1-800-438-1985. • are breastfeeding or plan to breastfeed. It is not known if VYNDAQEL or VYNDAMAX passes into your breast milk. You should not breastfeed during treatment with VYNDAQEL or VYNDAMAX. Talk to your healthcare provider about the best way to feed your baby during treatment with VYNDAQEL or VYNDAMAX. Tell your healthcare provider about all the medicines you take including any prescription or over-the-counter medicines, vitamins, and herbal supplements.
How should I take VYNDAQEL or VYNDAMAX? • Take either VYNDAQEL or VYNDAMAX exactly as your healthcare provider tells you to. • Take either VYNDAQEL or VYNDAMAX capsule(s) 1 time a day. • VYNDAQEL or VYNDAMAX capsule(s) should be swallowed whole and not crushed or cut. • If you miss a dose, 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.
What are the possible side effects of VYNDAQEL and VYNDAMAX? Diarrhea has been reported as a possible side effect during treatment with VYNDAQEL or VYNDAMAX in people with cardiomyopathy of transthyretin-mediated amyloidosis. You may report side effects to FDA at 1-800-FDA-1088.
How should I store VYNDAQEL and VYNDAMAX? • Store VYNDAQEL and VYNDAMAX capsules at room temperature between 68°F to 77°F (20°C to 25°C). • Keep VYNDAQEL and VYNDAMAX and all medicines out of the reach of children.
General information about the safe and effective use of VYNDAQEL and VYNDAMAX. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use VYNDAQEL or VYNDAMAX for a condition for which it was not prescribed. Do not give VYNDAQEL or VYNDAMAX to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about VYNDAQEL or VYNDAMAX that is written for healthcare professionals.
What are the ingredients in VYNDAQEL and VYNDAMAX? VYNDAQEL: Active ingredient: tafamidis meglumine Inactive ingredients: ammonium hydroxide 28%, brilliant blue FCF, carmine, gelatin, glycerin, iron oxide (yellow), polyethylene glycol 400, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, sorbitan monooleate, sorbitol, and titanium dioxide VYNDAMAX: Active ingredient: tafamidis 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 LAB-0573-4.0 For more information, go to www.vyndaqel.com or call 1-800-438-1985.