Approved Risk Evaluation and Mitigation Strategies (REMS)
Qsymia (phentermine and topiramate)
NDA #022580
REMS last update: 03/31/2021
What is the purpose of the REMS?
To inform prescribers and patients 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 patients 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 |
|
Before dispensing |
|
At all times |
|
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 Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Dear_Healthcare_Provider_letter.pdf |
Dear Medical Society Letter (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Dear_Medical_Society_letter.pdf |
Healthcare Provider Counseling Tool for Females of Reproductive Potential (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Healthcare_Provider_Counseling_Tool_for_Females_of_Reproductive_Potential.pdf |
Online Qsymia REMS Healthcare Provider Training (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Online_Qsymia_REMS_Healthcare_Provider_Training.pdf |
Online Qsymia REMS Pharmacy Training Module (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Online_Qsymia_REMS_Pharmacy_Training_module.pdf |
Pharmacy Enrollment Form, Corporate Entity of Retail Chain Pharmacy (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Pharmacy_Enrollment_Form_Corporate_Entity_of_Retail_Chain_Pharmacy.pdf |
Pharmacy Enrollment Form, Independent Pharmacy (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Pharmacy_Enrollment_Form_Independent_Pharmacy.pdf |
Pharmacy Enrollment Form, Mail Order Pharmacy (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Pharmacy_Enrollment_Form_Mail_Order_Pharmacy.pdf |
Prescriber Dosing and Management Checklis (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Prescriber_Dosing_and_Management_Checklist.pdf |
Print Qsymia REMS Healthcare Provider Training (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Print_Qsymia_REMS_Healthcare_Provider_Training .pdf |
Print Qsymia REMS Pharmacy Training Module (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Print_Qsymia_REMS_Pharmacy_Training_module.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_REMS_Full.pdf |
REMS Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_REMS_Website_Screenshots.pdf |
Risk of Birth Defects with Qsymia Patient Brochure (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Qsymia_2021_03_31_Risk_of_Birth_Defects_with_Qsymia_patient_brochure.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
03/31/2021 | Modified to replace gender-specific language in the REMS document and REMS materials with gender-neutral language. This modification aligns the REMS document and REMS materials with changes previously made to the Qsymia prescribing information. |
07/03/2017 | Revised to make editorial changes. |
09/26/2014 | Modified to:
|
04/16/2013 | Modified to:
|
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.
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