Approved Risk Evaluation and Mitigation Strategies (REMS)

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Natpara (parathyroid hormone)
BLA #125511
REMS last update: 08/04/2017



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.
    | REMS Program: An Introduction |
  • Successfully complete the Knowledge Assessment that is included in the Training Module for Prescribers, and submit it to the REMS Program.
    | Training Module for Prescribers |
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
    | Prescriber Enrollment Form |
Before treatment initiation
  • Counsel the patient on the appropriate use and risks associated with treatment using the Patient Brochure. Provide the patient with the Patient Brochure.
    | Patient Brochure |
  • 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.
    | Patient Prescriber Acknowledgement Form |

Patients who are prescribed Natpara

Before the first prescription
  • Enroll in the REMS Program by completing the Patient-Prescriber Acknowledgment Form with the prescriber. Enrollment information will be provided to the REMS Program.
    | Patient Prescriber Acknowledgement Form |
  • Receive counseling from the prescriber on the risk of osteosarcoma using the Patient Brochure.
    | Patient Brochure |

Pharmacies that dispense Natpara must

To become certified to dispense
  • Train all relevant staff involved in dispensing on REMS program requirements using the Training Module for Pharmacy Representatives.
    | Training Module for Pharmacy Representatives |
  • Establish processes and procedures to verify the prescriber is certified and a Patient-Prescriber Acknowledgement Form is on record for each patient prior to dispensing.
    | Patient Prescriber Acknowledgement Form |
  • 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 Natpara REMS Program: An Introduction.
    | REMS Program: An Introduction |
  • Have the authorized representative successfully complete the Knowledge Assessment that is included in the Training Module for Pharmacy Represenativies, and submit it to the REMS Program.
    | Training Module for Pharmacy Representatives |
  • Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form.
    | Pharmacy Enrollment Form |
Before dispensing
  • Verify that a prescriber is certified and the Patient-Prescriber Acknowledgment Form is on record the processes and procedures established as a requirement of the REMS Program against a list from the REMS Program Coordinating Center.
    | Patient Prescriber Acknowledgement Form |
To maintain certification to dispense, when a 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 Natpara REMS Program: An Introduction.
    | REMS Program: An Introduction |
  • Have the authorized representative review the drug’s Prescribing Information.
  • Have the authorized representative successfully complete the Knowledge Assessment that is included in the Training Module for Pharmacy Represenativies, and submit it to the REMS Program.
    | Training Module for Pharmacy Representatives |
At all times
  • Do not distribute, transfer, loan, or sell Natpara.
  • Maintain records of prescription data.
  • Comply with audits carried out by Shire, FDA, or a third party to ensure that all processes and procedures are in place and are being followed.

Wholesalers that distribute Natpara must

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to a certified pharmacy.
  • Train all relevant staff involved on REMS program requirements.
At all times
  • Maintain records of distribution data.
  • Comply with audits carried out by Shire, FDA, or thir party 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_2017-08-04_Frequently_Asked_Questions_FAQ.pdf
Patient Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Patient_Brochure.pdf
Patient Prescriber Acknowledgement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Patient_Prescriber_Acknowledgment_Form.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Presciber_Enrollment_Form.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Full.pdf
REMS Program: An Introduction (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_REMS_Program_An_Introduction.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_REMS_Website_Screenshots.pdf
Training Module for Pharmacy Representatives (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Training_Module_for_Pharmacy_Representatives.pdf
Training Module for Prescribers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Natpara_2017-08-04_Training_Module_for_Prescribers.pdf

What updates have been made to the REMS?

Date Summary of change
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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