VYNDAQEL® OR VYNDAMAX™ Patient Counseling Information

(tafamidis meglumine or tafamidis)

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.

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Patient Counseling 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.

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Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.