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To inform certified pharmacies and patients of reproductive potential about:
The increased risk of embryo-fetal toxicity with major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being small
for gestational age (SGA) in a fetus 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.
Designate an Authorized Representative to carry out
the certification process and oversee implementation
and compliance with the REMS on behalf of the
pharmacy.
Have the Authorized Representative successfully
complete the Qsymia REMS Pharmacy Training.
| Qsymia REMS Pharmacy Training |
Have the Authorized Representative enroll in the REMS
on behalf of the pharmacy by completing and
submitting the Pharmacy Enrollment Form to the
REMS.
| Pharmacy Enrollment Form |
Establish processes and procedures to provide the
Medication Guide and the Risk of Birth Defects with
Qsymia to each patient each time Qsymia is
dispensed.
| Medication Guide |
| Risk of Birth Defects with Qsymia |
Before dispensing
Provide the patient with the Medication Guide and the
Risk of Birth Defects with Qsymia through the
processes and procedures established as a
requirement of the REMS.
| Medication Guide |
| Risk of Birth Defects with Qsymia |
To maintain certification to dispense
Have the new Authorized Representative enroll in the
REMS by completing the Pharmacy Training and
completing and submitting the Pharmacy Enrollment
Form if the Authorized Representative changes.
| Pharmacy Enrollment Form |
| Qsymia REMS Pharmacy Training |
At all times
Not distribute, transfer, loan, or sell Qsymia.
9. Maintain records of standard operating procedures,
training, and providing the Medication Guide and the
Risk of Birth Defects with Qsymia.
| Medication Guide |
| Risk of Birth Defects with Qsymia |
Maintain and submit annual compliance reports to the
REMS.
Comply with audits carried out by VIVUS LLC or a third
party acting on behalf of VIVUS LLC to ensure that all
processes and procedures are in place and are being
followed.
Wholesalers-distributors that distribute Qsymia must:
To be able to distribute
Establish processes and procedures to ensure
that the drug is distributed only to certified
pharmacies.
At all times
Distribute only to certified pharmacies.
Maintain and submit annual compliance reports
of adherence to distribution requirements of the
REMS.
Comply with audits carried out by VIVUS LLC or a
third party acting on behalf of VIVUS LLC 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).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
02/06/2024
Modified to revise Qsymia labeling to be consistent with Topamax (topiramate) labeling. Additional modification details can be found in the supplement approval letter at Drugs@FDA.
05/09/2023
Modified to make changes to the REMS to align with updated labeling from prior approval supplement (S-021), which added a new indication for pediatric patients aged 12 years and older with BMI in the 95th percentile or greater for standardized age and sex including:
Global changes: new logo, updated product generic text, and updated language with respect to the indication, patient selection, and risk of teratogenicity to align with the updated labeling.
Revisions to the REMS document and REMS materials to reflect the consolidation of the Pharmacy Enrollment Form.
Revisions to the REMS document to update the method for completing pharmacy certification from “online and by phone” to “via fax or email” and remove the requirement to submit the Knowledge Assessment, located in the Qsymia REMS Pharmacy Training, to the REMS Program.
Title change for the Pharmacy Training Program to the Qsymia REMS Pharmacy Training.
Revisions to the newly consolidated Pharmacy Enrollment Form and Qsymia REMS Pharmacy Training to include updated attestations to align with the REMS document.
Revisions to the REMS website.
03/08/2022
Modified to convert the REMS document to the new standardized format and provide the Applicant’s name change throughout the REMS Document and REMS
materials. This modification also removes ETASU A, prescriber training, as an element of the REMS, updates the goals to reflect the removal of ETASU A, and removes the
REMS materials associated with prescriber training.
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:
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.
