Approved Risk Evaluation and Mitigation Strategies (REMS)

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Juxtapid (lomitapide)
NDA #203858
REMS last update: 03/02/2017

View the Juxtapid Prescribing Information and Medication Guide at DailyMed.
View Juxtapid's Regulatory Information at Drugs@FDA

What do participants need to know?

See the application holder(s) REMS Website or the approved REMS materials for more information. A general overview of the REMS is currently under development.

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

Healthcare Providers who prescribe Juxtapid must

To become certified to prescribe
  • Review the drug’s Prescribing Information.
  • Review the REMS Program Fact Sheet.
  • Successfully complete the Knowledge Assessment that is included in the Prescriber Training Module, and submit it to the REMS Program.
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
Before treatment initiation
  • Counsel the patient on the appropriate use and risks associated with Juxtapid using the Patient Guide. Provide a copy of the material to the patient.
  • Enroll the patient by completing and submitting the Patient-Prescriber Acknowledgement Form to the REMS Program.
During treatment; before each prescription
  • Complete the Prescription Authorization Form and submit it to the REMS program.

Patients who are prescribed Juxtapid

Before the first prescription
  • Review the Patient Guide.
  • Enroll in the REMS Program by completing the Patient-Prescriber Acknowlegement Form with the prescriber. Enrollment information will be provided to the REMS Program.
  • Receive counseling from the prescriber on the risk of liver toxicity, periodic liver function monitoring, and appropriate patient selection.

Pharmacies that dispense Juxtapid must

To become certified to dispense
  • Train all relevant staff involved in dispensing on the REMS program requirements using the Pharmacy Training Module.
  • Establish processes and procedures to ensure pharmacy staff obtain authorization to dispense each prescription by accessing the REMS Program database or calling the REMS Program Coordinating Center.
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative review the drug’s Prescribing Information.
  • Have the authorized representative review the Program Fact Sheet.
  • Have the authorized representative successfully complete the Knowledge Assessment that is included in the Pharmacy Training Material, and submit it to the REMS Program.
  • Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form.
Before dispensing
  • Obtain authorization to dispense each prescription by accessing the REMS Program database or calling the REMS Program Coordinating Center to verify the completion of the Patient-Prescriber Acknowledgment Form, certification of the prescriber, and receipt of the Prescription Authorization Form for each new prescription.
To maintain certification to dispense, if the pharmacy designates a new authorized represenative
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative review the drug’s Prescribing Information.
  • Have the authorized representative review the Program Fact Sheet.
  • Have the authorized representative successfully complete the Knowledge Assessment that is included in the Pharmacy Training Material, and submit it to the REMS Program.
  • Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form.
At all times
  • Maintain records of training, prescription data, and documentation that all processes and procedures are in place and are being followed and provide upon request to Aegerion, FDA, or a third party acting on behalf of Aegerion or FDA.
  • Comply with audits carried out by Aegerion, FDA, or a third party acting on behalf of Aegerion or FDA to ensure that all processes and procedures are in place and are being followed.

Wholesalers that distribute Juxtapid must

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
  • Train all relevant staff involved in distribution on the REMS Program Requirements.
At all times
  • Maintain records of distribution data of all shipments and documentation to support that all processes and procedures are in place, are being followed, and make the documentation available for audits.
  • Comply with audits carried out by Aegerion, FDA, or a third party on behalf of Aegerion or FDA 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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