Approved Risk Evaluation and Mitigation Strategies (REMS)

Palynziq (pegvaliase-pqpz)

BLA #761079

REMS last update: 12/09/2023

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

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the PALYNZIQ (pegvaliase-pqpz) REMS is to mitigate the risk of anaphylaxis associated with PALYNZIQ by:

1. Ensuring that prescribers are educated on the risk of anaphylaxis associated with the use of PALYNZIQ
2. Ensuring that prescribers are educated and adhere to the following:
   • Counsel patients on how to recognize and respond to signs and symptoms of anaphylaxis
   • Enroll patients in the PALYNZIQ REMS
   • Prescribe auto-injectable epinephrine with PALYNZIQ
3. Ensuring that PALYNZIQ is only dispensed to patients with documentation of safe use conditions
   • Patient education and enrollment in the PALYNZIQ REMS
   • Having auto-injectable epinephrine available at all timesM/li>
4. Ensuring that patients are educated on the following:
   • How to recognize and respond to signs and symptoms of anaphylaxis
   • The need to carry auto-injectable epinephrine with them at all times

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

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date	Summary of change
12/09/2023	Modified to change the timetable for submission of assessments of the REMS from yearly to every two years.
10/06/2020	Modified to: Align with prior approval supplements S-005,S-006, and S-007 Update logo Reflect formatting changes that attention to the safety video Clarify the pharmacy enrollment process Add Spanish language materials for prescribers, pharmacies, and patients
05/24/2018	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.