Advise the patient to read the FDA-approved patient labeling (Patient Information).
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)].
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
VYNDAQEL (VIN-duh-kel)(tafamidis meglumine)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:
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?
What are the possible side effects of VYNDAQEL and VYNDAMAX?There were no known side effects that happened 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?
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 meglumineInactive 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 dioxideVYNDAMAX:Active ingredient: tafamidisInactive 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-0573-5.0For more information, go to www.vyndaqel.com or call 1-800-438-1985.
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