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The goal of the NATPARA REMS Program is to mitigate the potential risk of osteosarcoma associated with NATPARA by:
Ensuring that prescribers are educated on the following:
potential risk of osteosarcoma associated with the use of NATPARA
appropriate patient selection
safe-use conditions required for prescribing NATPARA
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.
Successfully complete the Knowledge Assessment and submit it to the REMS
Program.
| Knowledge Assessment |
Enroll in the REMS by completing the Prescriber Enrollment Form and
submitting it to the REMS Program.
| Prescriber Enrollment Form |
Before treatment
initiation (first dose)
Counsel the patient on the appropriate use and risks associated with
NATPARA using the Patient Brochure. Provide a copy of the material to the
patient.
| 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 treatment
initiation
Receive counseling from the prescriber on the appropriate use and risks
associated with NATPARA 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.
| Patient-Prescriber Acknowledgement Form |
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 successfully complete the Knowledge
Assessment and submit it to the REMS Program.
| Knowledge Assessment |
Have the authorized representative enroll in the REMS Program by
completing the Pharmacy Enrollment Form and submitting it to the REMS
Program.
| Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing NATPARA on the 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
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.
Have any new authorized representative successfully complete the
Knowledge Assessment and submit it to the REMS Program.
| Knowledge Assessment |
Have any new authorized representative enroll in the REMS Program by
completing the Pharmacy Enrollment Form and submitting it to the REMS
Program.
| Pharmacy Enrollment Form |
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 Takeda Pharmaceuticals U.S.A., Inc. or a
third party acting on behalf of Takeda Pharmaceuticals U.S.A., 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 Takeda Pharmaceuticals U.S.A., Inc. or a
third party acting on behalf of Takeda Pharmaceuticals U.S.A., 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).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
09/14/2023
Updates to reflect change in application ownership
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.
