FDA.reportPublic FDA data

Juxtapid - Chiesi Farmaceutici, S.p.A.

Manufacturer
Chiesi Farmaceutici, S.p.A.
Effective date
2024-04-26
Label type
Risk Evaluation & Mitigation Strategies
Version
7
Source
full-release
Hydrated at
2026-06-04 22:50:43

Label at a glance#

ProductJuxtapid
Label structure5 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Application Number: NDA 203858
Application Holder: Chiesi Farmaceutici S.p.A.
Initial REMS Approval: 12/2012
Most Recent REMS Update: 04/2024

II. REMS Goal

REMS Goals

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.
  • JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
  • Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.

III. REMS Requirements

REMS REQUIREMENTS

Chiesi Farmaceutici S.p.A. must ensure that healthcare providers, patients, pharmacies, and wholesalers-distributors comply with the following requirements:

1. Healthcare Providers who prescribe JUXTAPID must:

REMS PARTICIPANT REQUIREMENTS

To become certified to prescribe1. Review the drug's Prescribing Information.
2. Review the following: Fact Sheet, Prescriber Training Module.
3. Successfully complete the Knowledge Assessment and submit it to the REMS Program.
4. Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
Before treatment initiation (first dose)5. 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.
6. Assess the patient to confirm a clinical or laboratory diagnosis consistent with the approved indication.
7. Assess the patient's liver function.
8. Enroll the patient by completing and submitting the Patient-Prescriber Acknowledgement Form to the REMS Program.
9. Order the prescription using the Prescription Authorization Form.
During treatment, at least monthly for the first year and every 3 months thereafter10. Assess the patient's liver function.
During treatment, before dose increases11. Assess the patient's liver function.
During treatment; before each prescription12. Order the prescription using the Prescription Authorization Form.

2. Patients who are prescribed JUXTAPID:

REMS PARTICIPANT REQUIREMENTS

Before treatment initiation1. Receive counseling from the prescriber on the appropriate use, risks of JUXTAPID, and need for periodic liver function monitoring using the Patient Guide.
2. Enroll in the REMS Program by completing the Patient-Prescriber Acknowledgement Form with the prescriber. Enrollment information will be provided to the REMS Program.
3. Get blood tests to check your liver.
During treatment4. Get blood tests as directed by your prescriber to check your liver so your prescriber can modify your JUXTAPID treatment, if needed.
At all times5. Inform the prescriber of signs and/or symptoms of liver injury.

3. Pharmacies that dispense JUXTAPID must:

REMS PARTICIPANT REQUIREMENTS

To become certified to dispense1. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
2. Have the authorized representative review the Prescribing Information, Fact Sheet and Pharmacy Training Module.
3. Have the authorized representative successfully complete the Knowledge Assessment and submit it to the REMS Program.
4. Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
5. 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.
6. Train all relevant staff involved in dispensing of JUXTAPID on the REMS Program requirements.
Before dispensing7. 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 dispense8. Have a new authorized representative enroll by completing and submitting the Pharmacy Enrollment Form, if the authorized representative changes.
At all times9. Not distribute, transfer, loan, or sell JUXTAPID.
10. Maintain records documenting staff's completion of REMS training.
11. Maintain and submit records of prescription data to the REMS Program.
12. Maintain records that all REMS processes and procedures are in place and are being followed.
13. 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.

4. Wholesalers-distributors that distribute JUXTAPID must:

REMS PARTICIPANT REQUIREMENTS

To be able to distribute1. Establish processes and procedures to ensure the drug is distributed only to certified pharmacies.
2. Train all relevant staff involved in distribution on the REMS requirements.
At all times3. Distribute only to certified pharmacies.
4. Maintain records of all drug distribution.
5. Maintain records that all REMS processes and procedures are in place and are being followed.
6. 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.

REMS APPLICANT REQUIREMENTS

Chiesi Farmaceutici S.p.A. must provide training to healthcare providers who prescribe JUXTAPID.

The training includes the following educational materials: Fact Sheet, Prescriber Training Module and Knowledge Assessment. The training must be available online or by contacting the REMS Program call center.

Chiesi Farmaceutici S.p.A. must provide training to pharmacies that dispense JUXTAPID.

The training includes the following educational materials: Fact Sheet, Pharmacy Training Module and Knowledge Assessment. The training must be available online or by contacting the REMS Program call center.

To support REMS Program operations, Chiesi Farmaceutici S.p.A. must:

  1. Establish and maintain a REMS Program website, www.JUXTAPIDREMSProgram.com. The REMS Program website must include the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and health care providers must include prominent REMS-specific links to the REMS Program website. The REMS Program website must not link back to the promotional product website(s).
  2. Make the REMS Program website fully operational and all REMS materials available through www.JUXTAPIDREMSProgram.com and the REMS Program call center.
  3. Establish and maintain a REMS Program call center for REMS participants at 1-85-JUXTAPID (1-855-898-2743).
  4. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the JUXTAPID REMS Program.
  5. Ensure prescribers and pharmacies are able to complete the certification process by email and fax.
  6. Ensure prescribers are able to enroll patients and submit completed Prescription Authorization Forms to the call center by fax.
  7. Ensure pharmacies are able to verify the prescriber is certified, the patient is enrolled, and a completed Prescription Authorization Form is received before dispensing each prescription by phone and online.
  8. Provide the Prescriber Training Module and Knowledge Assessment, Prescriber Enrollment Form, Fact Sheet, Patient-Prescriber Acknowledgement Form, Prescription Authorization Form, Pharmacy Training Module and Knowledge Assessment, Pharmacy Enrollment Form, Patient Guide, and the Prescribing Information to prescribers or pharmacies who (1) attempt to prescribe/dispense JUXTAPID and are not yet certified or (2) inquire about how to become certified.
  9. Notify prescribers and pharmacies within 48 hours after they become certified in the REMS Program.
  10. Provide certified pharmacies access to the database of certified prescribers and enrolled patients.
  11. Provide authorized wholesalers-distributors access to the database of certified pharmacies.

REMS APPLICANT REQUIREMENTS

To ensure REMS participants' compliance with the REMS Program, Chiesi Farmaceutici S.p.A. must:

  1. Verify annually that the authorized representative's name and contact information corresponds to those of the current designated authorized representative for the certified pharmacy. If different, require the pharmacy to re-certify with a new authorized representative.
  2. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: JUXTAPID distribution and dispensing; certification of prescribers and pharmacies; authorization of wholesalers-distributors, enrollment of patients; and audits of REMS participants. These records must be readily available for FDA inspections.
  3. Establish a plan for addressing noncompliance with REMS Program requirements.
  4. Monitor wholesalers-distributors, certified prescribers and certified pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if noncompliance is identified, including de-certification.
  5. Audit certified pharmacies no later than 60 days after they become certified, and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and support the REMS Program requirements.
  6. Audit wholesalers-distributors no later than 60 days after they become authorized, and annually thereafter to ensure that all REMS processes and procedures are in place, functioning, and support the REMS Program requirements.
  7. Take reasonable steps to improve implementation of and compliance with the requirements of the JUXTAPID REMS Program based on monitoring and evaluation of the JUXTAPID REMS Program.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Chiesi Farmaceutici S.p.A.must submit REMS Assessments every two years beginning with the 11-year REMS assessment due 12/21/2023. 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. Chiesi Farmaceutici S.p.A.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 JUXTAPID REMS:

Enrollment Forms

Prescriber:

1. Prescriber Enrollment Form

Patient:

2. Patient-Prescriber Acknowledgement Form

Pharmacy:

3. Pharmacy Enrollment Form

Training and Educational Materials

Prescriber:

4. Prescriber Training Module and Knowledge Assessment

5. Fact Sheet

Patient:

6. Patient Guide

Pharmacy:

7. Pharmacy Training Module and Knowledge Assessment

8. Fact Sheet

Patient Care Forms

9. Prescription Authorization Form

Other Materials

10. REMS Program Website (www.juxtapidREMSprogram.com)

DailyMed Product Concepts#

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db1e0578-c863-24bf-85ef-9cbb5c541fbdProduct name220150507

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 JUXTAPID safely and effectively. See full prescribing information for JUXTAPID. JUXTAPID ® (lomitapide) capsules, for oral use Initial U.S. Approval: 2012SPL related document2026-03-30Chiesi USA, Inc.20251004_679d161e-44fd-4872-aba9-6723b5b8576b.zip!e70ccb1f-7427-49d4-9b92-bdf493957bda.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JuxtapidLOMITAPIDE MESYLATEChiesi USA, Inc.61a0be9d-ee58-43e0-b5cb-1410118350812026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Juxtapid
JuxtapidLOMITAPIDE MESYLATEAmryt Pharmaceuticals DACe4c45bb5-15f4-437e-ab98-a649b3676d142026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Juxtapid

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Adverse event summaries are temporarily unavailable. Other product information remains available.