Approved Risk Evaluation and Mitigation Strategies (REMS)

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Qsymia (phentermine and topiramate)
NDA #22580
REMS last update: 09/26/2014

View the Qsymia Prescribing Information and Medication Guide at DailyMed.
View Qsymia's Regulatory Information at Drugs@FDA

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Pharmacies that dispense Qsymia must:

To become certified to dispense
  • Train all relevant staff involved in dispensing about the risks associated with Qsymia and the requirement to provide a Medication Guide and Risk of Birth Defects with Qsymia Patient Brochure each time the medication is dispensed.
  • Establish processes and procedures to verify that the Medication Guide and Risk of Birth Defects with Qsymia Patient Brochure are systematically directed to the patient through the pharmacy management system each time the medication is dispensed.
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative successfully complete the knowledge assessment that are included in the Qsymia REMS Pharmacy Training Program, and submit it to the REMS Program.
  • Have the authorized representative enroll in the REMS Program by completing the applicable enrollment form(s): Independent Pharmacy Enrollment Form, Corporate Entity of Retail Chain Pharmacy Enrollment Form, or Mail Order Pharmacy Enrollment form.
Before dispensing
  • Provide the patient with the Medication Guide and Risk of Birth Defects with Qsymia Patient Brochure.
  • Obtain authorization to dispense each prescription by processing the prescription through the pharmacy management system.
At all times
  • Do not distribute, transfer, loan, or sell Qsymia.
  • Maintain records of compliance reports and a list of prescribers.
  • Comply with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

Healthcare Providers who prescribe Qsymia

  • Receive training provided by the sponsor.
  • Review the educational materials for prescribers, including: Risk of Birth Defects with Qsymia Patient Brochure, Healthcare Provider Counseling Tool for Females of Reproductive Potential, and Prescriber Dosing and Management Checklist.
  • Complete the Healthcare Professional Training Program, including the knowledge assessment.
  • Report the completion of training to the sponsor using a form in the HCP Registration Form.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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