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 product-specific REMS website or the approved REMS materials for more information.

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

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.

Pharmacies that dispense Qsymia

To be able to dispense Qsymia
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative complete the Pharmacy Training Program, including the knowledge assessment.
  • Train all relevant staff involved in the dispensing of Qsymia on risks and REMS requirements.
  • Establish processes and procedures to verify that Medication Guide and Risk of Birth Defects with Qsymia patient brochure are provided each time the medication is dispensed.
  • Enroll in the REMS by completing and submitting the appropriate enrollment form: Independent Pharmacy, Corporate Entity of Retail Chain Pharmacy, and Mail Order Pharmacy.
Before dispensing Qsymia
  • Provide the patient with a copy of the Medication Guide and Risk of Birth Defects with Qysmia patient brochure.
  • Process the prescription through the pharmacy management system.
Ongoing
  • Do not distribute, transfer, loan, or sell product to other pharmacies/distributors.
  • Provide sponsor with records of compliance report and list of prescribers quarterly.
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

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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