Approved Risk Evaluation and Mitigation Strategies (REMS)

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Qsymia (phentermine and topiramate)

NDA #022580

REMS last update: 07/03/2017

Goals
Summary
REMS Materials
Update history

What is the purpose of the REMS?

To inform prescribers and females of reproductive potential about:

the increased risk of congenital malformations, specifically orofacial clefts, in infants exposed to Qsymia during the first trimester of pregnancy
the importance of pregnancy prevention for females of reproductive potential receiving Qsymia
the need to discontinue Qsymia immediately if pregnancy occurs.

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

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. \| Risk of Birth Defects with Qsymia patient brochure \| 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. \| Risk of Birth Defects with Qsymia patient brochure \| 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. \| Online Qsymia REMS Pharmacy Training module \| \| Print Qsymia REMS Pharmacy Training module \| Have the authorized representative enroll in the REMS Program by completing the appropriate Pharmacy Enrollment Form. \| Pharmacy Enrollment Form, Independent Pharmacy \| \| Pharmacy Enrollment Form, Corporate Entity of Retail Chain Pharmacy \| \| Pharmacy Enrollment Form, Mail Order Pharmacy \|
Before dispensing	Provide the patient with the Medication Guide and Risk of Birth Defects with Qsymia Patient Brochure. \| 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.

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. For a specific Medication Guide of a product in the Qsymia REMS, see the DailyMed link(s).

Material Name	Material Name Link
Dear Healthcare Provider (DHCP) letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_DHCP_letter.pdf
Dear Medical Society letter (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_DMS_letter.pdf
Healthcare Provider Counseling Tool for Females of Reproductive Potential (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Counseling_Tool.pdf
Online Qsymia REMS Healthcare Provider Training (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Online_training_HCP.pdf
Online Qsymia REMS Pharmacy Training module (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Online_module_pharmacy.pdf
Pharmacy Enrollment Form, Corporate Entity of Retail Chain Pharmacy (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Chain_Pharmacy_Enrollment_Form.pdf
Pharmacy Enrollment Form, Independent Pharmacy (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Independent_Pharmacy_Enrollment_Form.pdf
Pharmacy Enrollment Form, Mail Order Pharmacy (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Mail_Order_Pharmacy_Enrollment.pdf
Prescriber Dosing and Management Checklist (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Prescriber_Checklist.pdf
Print Qsymia REMS Healthcare Provider Training (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Print_training_HCP.pdf
Print Qsymia REMS Pharmacy Training module (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Print_module_pharmacy.pdf
REMS document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_REMS_document.pdf
REMS full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_REMS_full.pdf
REMS website screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_REMS_website_screenshot.pdf
Risk of Birth Defects with Qsymia patient brochure (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qysmia_2017-07-03_Patient_brochure.pdf

What updates have been made to the REMS?

Date	Summary of change
07/03/2017	Revised to make editorial changes.
09/26/2014	Modified to: Remove the requirement that The Dear Healthcare Provider letter be provided to MedWatch in the REMS document. Conform to the changes being made to the package insert. Specifically, the changes include updated data in the Healthcare Provider Training Program [online and print] and the Pharmacy Training Program [online and print], based on the final report for study OB-901, Fetal Outcomes Retrospective Topiramate Exposure Study (FORTRESS) in the REMS materials. Reformat of the table to list the acceptable contraception methods for females of reproductive potential in the Healthcare Provider Counseling Tool for Females of Reproductive Potential, the Healthcare Provider Training Program [online and print], and the Pharmacy Training Program [online and print].
04/16/2013	Modified to: Clarify dosing and administration instructions in the Medication Guide Revise the pharmacy certification ETASU expanding pharmacy enrollment requirements Revise the implementation system
11/01/2012	Modified to revise the facsimile number in the Qsymia Healthcare Provider Training program – Print Copy
07/17/2012	Approval of the REMS.

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.

Qsymia (phentermine and topiramate) NDA #022580 REMS last update: 07/03/2017