A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associate with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. The FDA has required a REMS for Qsymia^™.

The purpose of the Qsymia^™ REMS is to inform prescribers and females of reproductive potential about the:

• Increased risk of congenital malformation, specifically orofacial clefts, in infants exposed to Qsymia during the first trimester of pregnancy
• Importance of pregnancy prevention for females of reproductive potential receiving Qsymia^™
• Need to discontinue Qsymia^™ immediately if pregnancy occurs

For more information about the Qsymia^™ REMS and education, please visit www.QsymiaREMS.com.