Approved Risk Evaluation and Mitigation Strategies (REMS)

Natpara (parathyroid hormone)
BLA #125511
REMS last update: 06/05/2020



What is the purpose of the REMS?

The goal of the NATPARA REMS Program is to mitigate the potential risk of osteosarcoma associated with NATPARA by:

  1. ensuring that prescribers are educated on the following:
    1. potential risk of osteosarcoma associated with the use of NATPARA
    2. appropriate patient selection
    3. safe-use conditions required for prescribing NATPARA
  2. ensuring that NATPARA is dispensed only to patients informed about the potential risk of osteosarcoma associated with the use of NATPARA

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.

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

Healthcare Providers who prescribe Natpara must

To become certified to prescribe
  • Review the drug’s Prescribing Information.
  • Review the Natpara REMS program: An Introduction.
  • Review the following: Training Module for Prescribers
  • Successfully complete the Knowledge Assessment that is included in the Training Module for Prescribers, 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 on the appropriate use and risks associated with treatment using the Patient Brochure. Provide a copy of the material to the patient.
  • Enroll the patient by completing and submitting the Patient-Prescriber Acknowledgment Form to the REMS Program. Retain a completed copy in the patient’s record.

Patients who are prescribed Natpara

Before treatment initiation
  • Receive counseling from the prescriber on the appropriate use and risks associated with Naptara using the Patient Brochure.
  • Enroll in the REMS Program by completing the Patient-Prescriber Acknowledgment Form with the prescriber. Enrollment information will be provided to the REMS Program.

Pharmacies that dispense Natpara must

To become certified to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
  • Have the authorized representative review the Prescribing Information, REMS Program: An Introduction, and Training Module for Pharmacy Representatives.
    | Training Module for Pharmacy Representatives |
  • 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.
  • Train all relevant staff involved in dispensing NATPARA on the REMS program requirements using the Training Module for Pharmacy Representatives.
  • Establish processes and procedures to verify the prescriber is certified and the patient is enrolled in the REMS Program.
Before dispensing
  • Verify that the prescriber is certified, and the patient is enrolled in the REMS through the processes and procedures established as a requirement of the REMS Program.
To maintain certification to dispense
  • Have any new authorized representative review the Prescribing Information, REMS Program: An Introduction, and Training Module for Pharmacy Representatives.
    | Training Module for Pharmacy Representatives |
  • Have any new authorized representative successfully complete the Knowledge Assessment and submit it to the REMS Program.
  • Have any new authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
At all times
  • Not distribute, transfer, loan, or sell NATPARA.
  • Maintain records of staff’s completion of training.
  • Maintain records that all REMS processes and procedures are in place and are being followed.
  • Maintain and submit records of all prescription data to the REMS Program.
  • Comply with audits carried out by Shire-NPS Pharmaceuticals, Inc or a third party acting on behalf of Shire-NPS Pharmaceuticals, Inc to ensure that all processes and procedures are in place and are being followed.

Wholesalers-Distributers that distribute NATPARA 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 distributing NATPARA on the REMS requirements.
At all times
  • Distribute only to certified pharmacies.
  • Maintain and submit records of all shipments and distribution data.
  • Comply with audits carried out by Shire-NPS Pharmaceuticals, Inc or a third party acting on behalf of Shire-NPS Pharmaceuticals, Inc 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 Natpara REMS, see the DailyMed link(s).
Material Name Material Name Link
Frequently Asked Questions (FAQ) (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_Frequently_Asked_Questions_(FAQ).pdf
Patient Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_Patient_Brochure.pdf
Patient-Prescriber Acknowledgement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020-06_05_Patient_Prescriber_Acknowledgement_Form.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_5_Prescriber_Enrollment_Form.pdf
Prescriber Training Module (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_Prescriber_Training_Module.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_REMS_Document.pdf
REMS Program: An Introduction (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_REMS_Program_An_Introduction.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_REMS_Website_Screenshots.pdf
Training Module for Pharmacy Representatives (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2020_06_05_Training_Module_For_Pharmacy_Representatives.pdf

What updates have been made to the REMS?

Date Summary of change
06/05/2020 Modified to change the timetable for submission of assessments from annually to every two years beginning with the REMS assessment for year six (72-month) and modified the REMS document to the new format to align with the recommendations in the October 2017 Draft Guidance: Format and Content of a REMS Document.
08/04/2017 Revised to change the application holder's name.
09/29/2016 Modified to add an online prescriber certification process.
01/23/2015 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.

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