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Qsymia - Vivus LLC

Manufacturer
Vivus LLC
Effective date
2025-07-11
Label type
Risk Evaluation & Mitigation Strategies
Version
6
Source
full-release
Hydrated at
2026-06-04 22:50:42

Label at a glance#

ProductQsymia
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Embryo-fetal toxicity
Application Number: NDA 22580 (and authorized generic)
Application Holder: VIVUS LLC
Initial REMS Approval: 07/2012
Most Recent REMS Update: 07/2025

II. REMS Goal

REMS Goals

To inform certified pharmacies and patients of reproductive potential about:

  1. 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
  2. The importance of pregnancy prevention for patients of reproductive potential receiving Qsymia
  3. The need to discontinue Qsymia immediately if pregnancy occurs

III. REMS Requirements

REMS REQUIREMENTS

VIVUS LLC must ensure that pharmacies and wholesalers-distributors comply with the following requirements:

REMS PARTICIPANT REQUIREMENTS

1. Pharmacies that dispense Qsymia must:
To become certified to dispense
  • 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.
  • Have the Authorized Representative enroll in the REMS on behalf of the pharmacy by completing and submitting the Pharmacy Enrollment Form to the REMS.
  • Train all relevant staff involved in dispensing on the risks associated with Qsymia and requirement to provide the Medication Guide and Risk of Birth Defects with Qsymia using the Qsymia REMS Pharmacy Training.
  • 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.
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.
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.
At all times
  • Not distribute, transfer, loan, or sell Qsymia.
  • Maintain records of standard operating procedures, training, and providing the Medication Guide and the 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.

REMS PARTICIPANT REQUIREMENTS

2. 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.

REMS APPLICANT REQUIREMENTS

VIVUS LLC must provide training to pharmacies who dispense Qsymia.

The training includes the following educational material: Qsymia REMS Pharmacy Training. The training must be available online and hard copy by mail or fax.

REMS COMMUNICATION PLAN

To support REMS operations, VIVUS LLC must:

  1. Establish and maintain a REMS website, www.QsymiaREMS.com. The REMS website must include the capability to complete pharmacy certification via fax or email, to locate certified pharmacies, and the option to print the Prescribing Information, Medication Guide, and REMS materials. The product website for consumers and healthcare providers must include prominent REMS-specific links to the REMS website. The REMS website must not link back to the promotional product website.
  2. Make the REMS website fully operational and all REMS materials are available through the website within 90 calendar days of REMS modification.
  3. Establish and maintain a Support Center for REMS participants at 1-888-998-4887 and a REMS Pharmacy Support Center for pharmacists at 1-855-302-6698.
  4. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the Qsymia REMS.
  5. Ensure pharmacies are able to become certified via fax or email.
  6. Ensure that a Medication Guide is made available for dispensing with each Qsymia prescription.
  7. Provide the Qsymia REMS Pharmacy Training and the Prescribing Information to pharmacies who (1) attempt to dispense Qsymia and are not yet certified or (2) inquire about how to become certified.
  8. Notify pharmacies within 5 business days after they become certified in the REMS.
  9. Provide authorized wholesalers-distributors access to the database of certified pharmacies.

To ensure REMS participants' compliance with the REMS, VIVUS LLC must:

  1. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: Qsymia distribution and dispensing, certification of pharmacies, and audits of REMS participants. These records must be readily available for FDA inspections.
  2. Establish and maintain a plan for addressing noncompliance with REMS requirements.
  3. Monitor pharmacies and wholesalers-distributors on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including de-certification.
  4. Audit certified pharmacies in accordance with the audit plan no later than 180 calendar days after they become certified and conduct ongoing audits of pharmacies in accordance with the audit plan to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
  5. Audit wholesalers-distributors no later than 180 calendar days after the wholesaler-distributor is authorized and every two years thereafter to ensure that all processes and procedures are in place, functioning, and support the REMS requirements.
  6. Take reasonable steps to improve implementation of and compliance with the requirements in the Qsymia REMS based on monitoring and evaluation of the Qsymia REMS.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

VIVUS LLC must submit REMS Assessments at 6 months and 12 months from the date of initial approval of the REMS and annually thereafter. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. VIVUS LLC must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS Material

The following materials are part of the Qsymia REMS:

  • Enrollment Forms
    • Pharmacy
      • Pharmacy Enrollment Form
  • Training and Educational Materials
    • Pharmacy:
      • Qsymia REMS Pharmacy Training
    • Patient:
      • Medication Guide
      • Risk of Birth Defects with Qsymia
  • Other Materials

VI. Statutory Elements

REMS ELEMENTS

This REMS is required under section 505-1 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21.U.S.C. 355-1) and consists of the following elements:

  • Medication Guide
  • Elements to Assure Safe Use:
    • Pharmacies and health care settings that dispense Qsymia are specially certified under 505-1(f)(3)(B)
  • Implementation System
  • Timetable for Submission of Assessments

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use QSYMIA ® safely and effectively. See full prescribing information for QSYMIA. QSYMIA (phentermine and topiramate extended-release capsules), for oral use, CIV Initial U.S. Approval: 2012SPL related document2026-04-22Vivus LLC | Catalent20250911_dfa78a0e-5dde-4144-a279-667cbf2e8216.zip!e04f4223-b2b4-49e5-a101-e3372cebeb4f.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QsymiaPHENTERMINE AND TOPIRAMATEVivus LLC40dd5602-53da-45ac-bb4b-15789aba40f92026-04-22Warnings, Adverse reactionsName fallback
brand name: Qsymia

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