Approved Risk Evaluation and Mitigation Strategies (REMS)

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Natpara (parathyroid hormone)
BLA #125511
REMS last update: 01/23/2015

View the Natpara Prescribing Information and Medication Guide at DailyMed.
View Natpara's Regulatory Information at Drugs@FDA

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

To be able to prescribe Natpara
  • Review the prescribing information for Natpara.
  • Review the educational materials for prescribers, including: Natpara REMS Program: An Introduction.
  • Complete the Training Module for Prescribers, including the knowledge assessment.
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
Before writing the first prescription for a patient
  • Counsel the patient on the appropriate use and risks associated with Natapara using the Patient Brochure.
  • Enroll the patient by completing and submitting the Patient-Prescriber Acknowledgment Form. Retain a completed copy in the patient’s record.

Patients who receive Natpara

To be able to receive Natpara
  • Enroll in the REMS by completing the Patient-Prescriber Enrollment Form with the prescriber.
Before receiving the initial Natpara prescription
  • Receive counseling from the prescriber on the potential risk of osteosarcoma.

Pharmacies that dispense Natpara

Ongoing
  • Re-enroll in the Natpara REMS program if the pharmacy designates someone else as the authorized representative.
  • Do not distribute, transfer, loan, or sell product.
  • Provide sponsor with records of prescription data.
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.
To be able to dispense Natpara
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative review the prescribing information for Natpara.
  • Have the authorized representative review the educational materials for dispensers, including: Natpara REMS Program: An Introduction.
  • Have the authorized representative complete the Training Module for Pharmacy Representatives, including the knowledge assessment.
  • Train all relevant staff involved in the dispensing of Natpara.
  • Enroll in the REMS by completing and submitting the REMS Pharmacy Enrollment Form.
Before dispensing Natpara
  • Obtain authorization to dispense by contacting the Natpara REMS Program Coordinating Center.

Wholesalers that distribute Natpara

To be able to distribute Natpara
  • Establish processes and procedures in place to verify that Natpara is distributed only to certified pharmacies.
  • Train all relevant staff on the Natpara REMS Program requirements.
Ongoing
  • Maintain distribution records and provide sponsor with the distribution data.
  • Cooperate with audits carried out by the sponsor 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:


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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