The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
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).
Review the following: Fact Sheet, Prescriber Training Module.
Successfully complete the Knowledge Assessment 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 (first
dose)
Counsel the patient about the appropriate use, risks associated with
JUXTAPID, and need for periodic liver function monitoring using the
Patient Guide. Provide a copy of the material to the patient.
Assess the patient to confirm a clinical or laboratory diagnosis
consistent with the approved indication.
Assess the patient’s liver function.
Enroll the patient by completing and submitting the Patient-
Prescriber Acknowledgement Form to the REMS Program.
Order the prescription using the Prescription Authorization Form.
During treatment,
at least monthly
for the first year
and every 3
months thereafter
Assess the patient’s liver function.
During treatment,
before dose
increases
Assess the patient’s liver function.
During treatment;
before each
prescription
Order the prescription using the Prescription Authorization Form.
Patients who are prescribed JUXTAPID:
Receive counseling from the prescriber on the appropriate use, risks
of JUXTAPID, and need for periodic liver function monitoring using
the Patient Guide.
Receive counseling from the prescriber on the appropriate use, risks
of JUXTAPID, and need for periodic liver function monitoring using
the Patient Guide.
Enroll in the REMS Program by completing the Patient-Prescriber
Acknowledgement Form with the prescriber. Enrollment information
will be provided to the REMS Program.
Get blood tests to check your liver.
During treatment
Get blood tests as directed by your prescriber to check your liver so
your prescriber can modify your JUXTAPID treatment, if needed.
At all times
Inform the prescriber of signs and/or symptoms of liver injury.
Pharmacies that dispense JUXTAPID must:
To become
certified to
dispense
Designate an authorized representative to carry out the certification
process and oversee implementation and compliance with the REMS
Program on behalf of the pharmacy.
Have the authorized representative review the Prescribing
Information, Fact Sheet and Pharmacy Training Module.
Have the authorized representative successfully complete the
Knowledge Assessment and submit it to the REMS Program.
Have the authorized representative enroll in the REMS Program by
completing the Pharmacy Enrollment Form and submitting it to the
REMS Program.
Establish processes and procedures to verify the prescriber is
certified, the patient is enrolled, and a completed Prescription
Authorization Form is received for each prescription.
Train all relevant staff involved in dispensing of JUXTAPID on the
REMS Program requirements.
Before dispensing
Verify that the prescriber is certified, the patient is enrolled, and a
completed Prescription Authorization Form for the patient is received
for each prescription through the processes and procedures
established as a requirement of the REMS Program.
To maintain
certification to
dispense
Have a new authorized representative enroll by completing and
submitting the Pharmacy Enrollment Form, if the authorized
representative changes.
At all times
Not distribute, transfer, loan, or sell JUXTAPID.
Maintain records documenting staff’s completion of REMS training.
Maintain and submit records of prescription data to the REMS
Program.
Maintain records that all REMS processes and procedures are in place
and are being followed.
Comply with audits carried out by Chiesi Farmaceutici S.p.A.or a
third-party acting on behalf of Chiesi Farmaceutici S.p.A., to ensure
that all processes and procedures are in place and are being
followed.
Wholesalers-distributors that distribute JUXTAPID must:
To be able to
distribute
Establish processes and procedures to ensure the drug is distributed
only to certified pharmacies.
Train all relevant staff involved in distribution on the REMS
requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of all drug distribution.
Maintain records that all REMS processes and procedures are in place
and are being followed.
Comply with audits carried out by Chiesi Farmaceutici S.p.A.or a
third-party acting on behalf of Chiesi Farmaceutici S.p.A., to ensure
that all processes and procedures are in place and are being
followed.
Assessment Plan
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
04/26/2024
Revised to update the Prescriber Authorization Form to have the prescriber signature on same page as the drug order to meet various states’ Board of Pharmacy requirements.
01/25/2024
Revised to reflect change in application ownership.
06/16/2022
Modified to reflect:
A revised Prescription Authorization Form (PAF) consolidated to one page instead of 2 pages, so that the prescriber signature and the drug order are not separated by a page break
Addition of state-specific pharmacy practice language to increase pharmacy usability and reduce necessity of pharmacy intervention on incoming prescriptions in the PAF as follows:
“The prescriber shall comply with his/her state-specific prescription requirements such as e-prescribing, state-specific prescription form, fax language, etc., as required. Noncompliance with state-specific requirements could result in pharmacy outreach to the prescriber.”
Removal of the “scan and email” option from the PAF.
Updated the Juxtapid (lomitapide) REMS website screenshots to align with changes to the PAF
02/01/2022
Modified to:
Update the format of the REMS document in line with the recommendations in
the Format and Content of a REMS Document- Guidance for Industry.
Change program materials secondary to findings of the completed Qualitative
Research (QR) around the deficit of prescriber knowledge on program
requirements around liver monitoring as demonstrated in recent poor KAB survey
scores.
Make editorial changes such as added demographic fields to Patient Guide, Patient
Prescriber Acknowledgement Form (PPAF) and Prescription Authorization Form
(PAF) and other editorial revisions related to punctuation, grammar, spelling,
defining acronyms, flow, font, simplification, and consistency to REMS appended
materials.
05/27/2021
Modified to add online fillable fields in REMS forms and modified the design and formatting of the REMS materials.
10/21/2020
Revised to make editorial changes.
05/18/2020
Revised to reflect change in ownership.
03/13/2020
Revised to make editorial changes.
06/13/2019
Revised to update the corporate address.
06/18/2018
Revised to make an editorial change.
06/04/2018
Modified to:
remove the option of emailing completed Patient-Prescriber Authorization Forms (PPAFs) for protection of patient information
require patients reaching age 18 to sign a PPAF (previously signed by a parent)
add language on the website to clarify the order of actions for prescriber participation in the REMS
establish an all-electronic process for submission of the certificate of completion of training and knowledge assessment
streamline the process for completion of the prescriber enrollment form (use of auto-completion of the form using prescriber information already submitted)
add text to the REMS website requesting pharmacies to contact Aegerion before attempting to certify
update font colors on REMS forms to enhance readability
add clarifying language on the Prescription Authorization Form (PAF) regarding how to submit a prescription
03/02/2017
Revised to make an editorial change.
01/03/2017
Modified to conform to the Safety Labeling Change Notification/REMS Modification Notification letter issued on March 11, 2016 in the REMS document, the existing REMS materials, and the following new REMS materials: Patient Guide and Patient-Prescriber Acknowledgement Form.
08/13/2013
Modified to allow prescribers to complete the REMS-required training and enrollment online.
12/21/2012
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.
