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The goal of the PALYNZIQ (pegvaliase-pqpz) REMS is to mitigate the risk of anaphylaxis associated with PALYNZIQ by:
Ensuring that prescribers are educated on the risk of anaphylaxis associated with the use of PALYNZIQ
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
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>
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.
Enroll in the REMS by completing the Prescriber Enrollment Form and
submitting it to the REMS.
| Prescriber Enrollment Form |
Before treatment
initiation (first dose)
Assess the patient’s need for an adult observer and for premedication as
described in the Prescriber Guide.
| Prescriber Guide |
Counsel the patient on the risk for anaphylaxis, including how to recognize
and respond to signs and symptoms of anaphylaxis and having autoinjectable
epinephrine available at all times using the Patient Guide, Safety
Video, and Wallet Card.
| Wallet Card |
| Safety Video |
| Patient Guide |
Provide the patient with the Patient Guide and Wallet Card, and direct the
patient to PALYNZIQREMS.com to view the Safety Video.
| Wallet Card |
| Safety Video |
| Patient Guide |
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.
| Patient Enrollment Form |
Provide the patient with a prescription for auto-injectable epinephrine to
accompany the prescription for PALYNZIQ.
During treatment;
before each
prescription
Assess the patient for anaphylaxis episodes.
Assess the patient’s supply of auto-injectable epinephrine.
Provide a prescription for auto-injectable epinephrine, if the patient’s supply
is inadequate.
At all times
Report anaphylaxis episodes to the REMS.
Report treatment discontinuation or transfer of care to the REMS.
Enroll in the REMS by completing the Patient Enrollment Form with the
prescriber. Enrollment information will be provided to the REMS.
| Patient Enrollment Form |
Receive counseling from the prescriber on how to recognize and respond to
signs and symptoms of anaphylaxis, and having auto-injectable epinephrine
with you at all times using the Patient Guide, Safety Video, and Wallet Card.
| Wallet Card |
| Safety Video |
| Patient Guide |
Adhere to the safe use conditions including obtaining auto-injectable
epinephrine.
At all times
Inform the prescriber if you have a severe allergic reaction (anaphylaxis).
Inform the prescriber if you need more auto-injectable epinephrine.
Have auto-injectable epinephrine and the Wallet Card with you.
| Wallet Card |
Inform all doctors about this treatment.
Report a change in prescriber or contact information to the REMS.
Report treatment discontinuation to the REMS.
Pharmacies that dispense PALYNZIQ must:
To become certified to
dispense
Designate an authorized representative to carry out the certification process
and oversee implementation and compliance with the REMS on behalf of the
pharmacy.
Have the authorized representative review the REMS Program Overview.
| Program Overview |
Have the authorized representative enroll in the REMS by completing and
submitting the Pharmacy Enrollment Form.
| Pharmacy Enrollment Form |
Establish processes and procedures to verify and document the patient has
auto-injectable epinephrine and report anaphylaxis episodes to the
REMS/manufacturer/prescriber.
Train all relevant staff involved in the dispensing of PALYNZIQ on the
requirements using the REMS Program Overview.
| Program Overview |
Before Dispensing
Verify and document that the patient has auto-injectable epinephrine
through the processes and procedures established as a requirement of the
REMS.
Obtain authorization to dispense each prescription by contacting the REMS
to verify prescriber certification and patient enrollment.
To maintain
certification to
dispense
Have the new authorized representative enroll in the REMS by completing
the Pharmacy Enrollment Form if the authorized representative changes.
| Pharmacy Enrollment Form |
At all times
Report anaphylaxis episodes to the REMS.
Not distribute, transfer, loan, or sell PALYNZIQ, except to certified
dispensers.
Maintain records documenting staff’s completion of REMS training.
Maintain records that all processes and procedures are in place and are
being followed.
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.
Wholesalers-distributors that distribute PALYNZIQ 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 on the REMS requirements.
At all times
Distribute only to certified pharmacies and maintain records of all
distributions.
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.
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 Palynziq REMS, see the DailyMed link(s).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.
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.
