FDA.reportPublic FDA data

PALYNZIQ - BioMarin Pharmaceutical Inc.

Manufacturer
BioMarin Pharmaceutical Inc.
Effective date
2026-03-20
Label type
Risk Evaluation & Mitigation Strategies
Version
2
Source
full-release
Hydrated at
2026-06-04 22:50:45

Label at a glance#

ProductPALYNZIQ
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Anaphylaxis
Application Number: BLA 761079
Application Holder: BioMarin Pharmaceutical Inc.
Initial REMS Approval: 05/2018
Most Recent REMS Update: 03/2026

II. REMS Goal

REMS Goals

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

III. REMS Requirements

REMS REQUIREMENTS

BioMarin Pharmaceutical Inc. must ensure that healthcare providers, patients, pharmacies, and wholesalers-distributors comply with the following requirements:

1. Healthcare Providers who prescribe PALYNZIQ must:

REMS PARTICIPANT REQUIREMENTS

To become certified to prescribe1. Review the drug's Prescribing Information.
2. Review the following: Prescriber Guide and REMS Overview.
3. Successfully complete the Prescriber Knowledge Assessment and submit it to the REMS.
4. Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS.
Before treatment initiation (first dose)5. Assess the patient's need for an adult observer and for premedication as described in the Prescriber Guide.
6. Counsel the patient on the risk of anaphylaxis, including how to recognize and respond to signs and symptoms of anaphylaxis and having epinephrine available at all times using the Patient Guide, Safety Video, and Wallet Card.
7. Provide the patient with the Patient Guide and Wallet Card, and direct the patient to PALYNZIQREMS.com to view the Safety Video.
8. Enroll the patient in the REMS by completing and submitting the Patient Enrollment Form. Provide a completed copy of the form to the patient and retain a completed copy in the patient's record.
9. Provide the patient with a prescription for epinephrine to accompany the prescription for PALYNZIQ.
During treatment; before each prescription10. Assess the patient for anaphylaxis episodes.
11. Assess the patient's supply of epinephrine.
12. Provide a prescription for epinephrine if the patient's supply is inadequate.
At all times13. Report anaphylaxis episodes to the REMS.
14. Report treatment discontinuation or transfer of care to the REMS.

2. Patients who are prescribed PALYNZIQ:

REMS PARTICIPANT REQUIREMENTS

Before treatment initiation1. Review the Patient Guide, Safety Video, and Wallet Card.
2. Enroll in the REMS by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS.
3. Receive counseling from the prescriber about how to recognize and respond to signs and symptoms of anaphylaxis, and having epinephrine with you at all times using the Patient Guide, Safety Video, and Wallet Card.
4. Adhere to the safe use conditions including obtaining epinephrine.
At all times5. Inform the prescriber if you have a severe allergic reaction (anaphylaxis).
6. Inform the prescriber if you need more epinephrine.
7. Have epinephrine and the Wallet Card with you.
8. Inform all healthcare providers about this treatment.
9. Report a change in prescriber or contact information to the REMS.
10. Report treatment discontinuation to the REMS.

3. Pharmacies that dispense PALYNZIQ must:

REMS PARTICIPANT REQUIREMENTS

To become certified to dispense1. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
2. Have the authorized representative review the REMS Overview.
3. Have the authorized representative enroll in the REMS by completing and submitting the Pharmacy Enrollment Form.
4. Establish processes and procedures to verify and document the patient has epinephrine and report anaphylaxis episodes to the REMS/manufacturer/prescriber.
5. Train all relevant staff involved in the dispensing of PALYNZIQ on the requirements using the REMS Overview.
Before Dispensing6. Verify and document that the patient has epinephrine through the processes and procedures established as a requirement of the REMS.
7. Obtain authorization to dispense each prescription by contacting the REMS to verify prescriber certification and patient enrollment.
To maintain certification to dispense8. Have the new authorized representative enroll in the REMS by completing the Pharmacy Enrollment Form if the authorized representative changes.
At all times9. Report anaphylaxis episodes to the REMS.
10. Not distribute, transfer, loan, or sell PALYNZIQ, except to certified pharmacies.
11. Maintain records documenting staff's completion of REMS training.
12. Maintain records that all processes and procedures are in place and are being followed.
13. Comply with audits carried out by BioMarin Pharmaceutical Inc. or a third party acting on behalf of BioMarin Pharmaceutical Inc. to ensure that all processes and procedures are in place and are being followed.

4. Wholesalers-distributors that distribute PALYNZIQ must:

REMS PARTICIPANT REQUIREMENTS

To be able to distribute1. Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
2. Train all relevant staff involved in distributing on the REMS requirements.
At all times3. Distribute only to certified pharmacies and maintain records of all distributions.
4. Comply with audits carried out by BioMarin Pharmaceutical Inc. or a third party acting on behalf of BioMarin Pharmaceutical Inc. to ensure that all processes and procedures are in place and are being followed.

REMS APPLICANT REQUIREMENTS

BioMarin Pharmaceutical Inc. must provide training to healthcare providers who prescribe PALYNZIQ.

The training includes the following educational materials: Prescriber Guide, REMS Overview and Prescriber Knowledge Assessment. The training must be available online and by hard-copy via fax or mail.

BioMarin Pharmaceutical Inc. must provide training to pharmacies who dispense PALYNZIQ.

The training includes the following educational material: REMS Overview. The training must be available online and by hard-copy via fax or mail.

To support REMS operations, BioMarin Pharmaceutical Inc. must:

1. Establish and maintain a REMS Website, PALYNZIQREMS.com. The REMS Website must include the capability to complete prescriber certification online, direct pharmacies on how to initiate an enrollment inquiry, the capability to enroll patients online, obtain authorization to dispense, report anaphylaxis episodes online, to view the Safety Video, and the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS Website. The REMS Website must not link back to the promotional product website(s).

2. Make the REMS Website fully operational and all REMS materials available through the website or call center by the date PALYNZIQ is first commercially distributed.

3. Establish and maintain a REMS call center for REMS participants at 1-855-758-REMS (1-855-758-7367).

4. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the PALYNZIQ REMS.

5. Ensure that prescribers are able to become certified in the REMS by mail, fax, and online.

6. Ensure that prescribers are able to enroll patients in the REMS by fax and online.

7. Ensure that pharmacies are able to become certified in the REMS by fax.

8. Ensure pharmacies are able to verify patient enrollment and prescriber certification and obtain dispensing authorization by phone or online.

9. Ensure prescribers, patients, and pharmacies are able to report anaphylaxis episodes by phone or online.

10. Provide the Prescriber Guide, Prescriber Enrollment Form, Prescriber Knowledge Assessment, REMS Overview, Patient Guide, Patient Enrollment Form, Wallet Card, Safety Video, and Prescribing Information to prescribers who (1) attempt to prescribe PALYNZIQ and are not yet certified or (2) inquire about how to become certified.

11. Provide the Pharmacy Enrollment Form and REMS Overview to pharmacies who (1) attempt to dispense PALYNZIQ and are not yet certified or (2) inquire about how to become certified.

12. Notify prescribers, patients, and pharmacies within two business days after they become enrolled and/or certified in the REMS.

13. Provide certified prescribers access to the database of certified pharmacies and their enrolled patients.

14. Provide certified pharmacies access to the database of certified prescribers and enrolled patients.

To ensure REMS participants' compliance with the REMS, BioMarin Pharmaceutical Inc. must:

15. Verify annually that the designated authorized representative for the certified pharmacy remains the same. If different, the pharmacy must recertify with a new authorized representative.

16. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: PALYNZIQ distribution and dispensing; certification of prescribers and pharmacies; enrolled patients; and audits of REMS certified pharmacies and wholesalers-distributors. These records must be readily available for FDA inspections.

17. Establish and maintain a plan for addressing noncompliance with REMS requirements.

18. Monitor prescribers and pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if noncompliance is identified, including decertification.

19. Audit all pharmacies no later than 90 calendar days after they become certified, and annually thereafter, to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.

20. Audit all wholesalers-distributors no later than 180 calendar days after they become authorized, and annually thereafter, to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.

21. Take reasonable steps to improve implementation of and compliance with the requirements in the PALYNZIQ REMS based on monitoring and evaluation of the PALYNZIQ REMS.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

BioMarin Pharmaceutical Inc. must submit REMS Assessments on May 24, 2025 and every two years thereafter. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. BioMarin Pharmaceutical Inc. must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS Material

The following materials are part of the PALYNZIQ REMS:

Enrollment Forms

Prescriber:

1. Prescriber Enrollment Form

Patient:

2. Patient Enrollment Form

Pharmacy:

3. Pharmacy Enrollment Form

Training and Educational Materials

Prescriber:

4. Prescriber Guide

5. Prescriber Knowledge Assessment

Patient:

6. Patient Guide

7. Safety Video

8. Wallet Card

Pharmacy:

9. REMS Overview

Other Materials

10. REMS Website

VI. Statutory Elements

REMS ELEMENTS

This REMS is required under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Elements to Assure Safe Use:
    • Health care providers who prescribe PALYNZIQ are specially certified under 505-1(f)(3)(A).
    • Pharmacies and health care settings that dispense PALYNZIQ are specially certified under 505-1(f)(3)(B).
    • PALYNZIQ is dispensed to patients with evidence or other documentation of safe-use conditions, under 505-1(f)(3)(D).
  2. Implementation System
  3. Timetable for Submission of Assessments of the REMS

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use PALYNZIQ safely and effectively. See full prescribing information for PALYNZIQ. PALYNZIQ (pegvaliase-pqpz) injection, for subcutaneous use Initial U.S. Approval: 2018SPL related document2026-03-02BioMarin Pharmaceutical Inc.20260503_05538ea9-6dcf-4dc8-a184-1ea8fbd10145.zip!bd5464fb-6d48-4646-943a-993ccad8d3ee.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PalynziqPEGVALIASE-PQPZBioMarin Pharmaceutical Inc.6dba844a-db02-44f8-8593-ce497ed9406c2026-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Palynziq

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