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The goal of the PALFORZIA REMS Program is to mitigate the risk of anaphylaxis associated with PALFORZIA by:
Ensuring that healthcare providers who prescribe and healthcare settings that dispense and administer PALFORZIA are educated on the following:
the risk of anaphylaxis associated with the use of PALFORZIA
the Initial Dose Escalation and first dose of each new Up-Dosing level must only be administered to patients in a healthcare setting equipped to monitor patients, and to identify and manage anaphylaxis.
Ensuring that the Initial Dose Escalation and the first dose of each new Up-Dosing level of PALFORZIA are only dispensed and distributed to certified healthcare settings and only administered to patients in certified healthcare settings.
Ensuring that PALFORZIA is only dispensed and administered to patients who are informed, by enrolling in the PALFORZIA REMS Program, of the need to have injectable epinephrine available for immediate use at all times, the need for monitoring with the Initial Dose Escalation and first dose of each new Up-Dosing level, the need for continued dietary peanut avoidance, and how to recognize the signs and symptoms of anaphylaxis.
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.
Healthcare providers who prescribe PALFORZIA must:
To become certified to
prescribe
Review the PALFORZIA Prescribing Information.
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)
Enroll the patient by completing and submitting the Patient Enrollment
Form to the REMS Program. Provide a completed copy of the form to the
patient.
| Patient Enrollment Form |
Counsel the patient on the need to have injectable epinephrine available
for immediate use at all times, the need for monitoring with the Initial
Dose Escalation and first dose of each new Up-Dosing level, the need for
continued peanut avoidance in the diet, and how to recognize the signs
and symptoms of anaphylaxis.
Assess the patient’s supply of injectable epinephrine and provide
prescription if necessary.
During treatment; before
dispensing the first dose of
each new Up-Dosing level
Assess the patient’s tolerability of the previous dosing level and
appropriateness of continuing the new Up-Dosing.
During treatment; before
prescribing a Daily Dose Pack
to be dispensed from a
certified pharmacy to a patient
for home use
Verify the patient was monitored and previously tolerated the first dose
of the new Up-Dosing level.
During treatment; before
dispensing a Daily Dose Pack
directly from the healthcare
setting to the patient for home
use
Verify the patient was monitored and previously tolerated the first dose
of the new Up-Dosing level.
At all times
Report anaphylaxis including suspected cases managed as anaphylaxis
to the REMS Program using the Anaphylaxis Adverse Event Reporting
Form.
| Anaphylaxis Adverse Event Reporting Form |
Report treatment discontinuation or transfer of care to the REMS
Program.
Patients who are prescribed PALFORZIA:
Before treatment initiation
Enroll in the REMS Program by completing the Patient Enrollment Form
with the prescriber. Enrollment information will be provided to the REMS
Program.
| Patient Enrollment Form |
Receive counseling from the prescriber on the need to have injectable
epinephrine available for immediate use at all times, the need for
monitoring with the Initial Dose Escalation and the first dose of each
new Up-Dosing level, the need for continued peanut avoidance in the
diet, and how to recognize the signs and symptoms of anaphylaxis.
During treatment, before the
first dose of each new Up-
Dosing level
Receive counseling from a healthcare provider on the need for
monitoring for anaphylaxis.
During treatment, during and
after administration of the
Initial Dose Escalation and the
first dose of each new Up-
Dosing level, for at least 60
minutes
Be monitored for anaphylaxis at the healthcare setting.
At all times
Report anaphylaxis to your healthcare provider.
Inform your healthcare provider if you need more injectable epinephrine.
Have injectable epinephrine available for immediate use.
Adhere to the safe use conditions: avoid peanuts and foods that contain
peanuts.
Healthcare settings that dispense PALFORZIA must:
During treatment; before the
first dose of each new Up-
Dosing level
Verify that the patient is enrolled in the REMS through the processes and
procedures established as a requirement of the REMS Program.
Counsel the patient on the need for monitoring for anaphylaxis.
Verify that the dose, as determined by the certified prescriber, is
dispensed from either the Office Dose Kit or the Daily Dose Pack through
the processes and procedures established as a requirement of the REMS
Program.
Verify that the patient has injectable epinephrine through the processes
and procedures established as a requirement of the REMS Program.
During and after administering
the Initial Dose Escalation and
the first dose of each new Up-
Dosing level, for at least 60
minutes
Assess the patient for anaphylaxis through the processes and procedures
established as a requirement of the REMS Program.
During treatment; before
dispensing a Daily Dose Pack
directly to the patient for
home use
Verify the patient was monitored and previously tolerated the first dose
of each new Up-Dosing level through processes and procedures
established as a requirement of the REMS Program.
To maintain certification to
dispense
Have a new Authorized Representative enroll in the REMS Program by
completing the Healthcare Setting Enrollment Form if the authorized
representative changes.
| Healthcare Setting Enrollment Form |
At all times
Report anaphylaxis including suspected cases managed as anaphylaxis
to the REMS Program using the Anaphylaxis Adverse Event Reporting
Form.
| Healthcare Setting Enrollment Form |
Not distribute, transfer, loan or sell PALFORZIA.
Maintain records of dispensing and that all processes and procedures are
in place and are being followed.
Only use patient-specific Initial Dose Escalation and Daily Dose Packs for
the intended patient
Comply with audits carried out by Aimmune Therapeutics, Inc., or a third
party acting on behalf of Aimmune Therapeutics, Inc., to ensure that all
processes and procedures are in place and are being followed.
To become certified to
dispense
Have healthcare provider(s) on-site to monitor for and manage
anaphylaxis.
Have a certified prescriber on-site.
Be able to manage anaphylaxis on-site.
Designate an authorized representative to carry out the certification
process and oversee implementation and compliance with the REMS
Program on behalf of the healthcare setting.
Have the authorized representative enroll in the REMS Program by
completing the Healthcare Setting Enrollment Form and submitting it to
the REMS Program.
| Healthcare Setting Enrollment Form |
Train all relevant staff involved in dispensing and administering
PALFORZIA using the Education Program for Healthcare Settings.
| Education Program for Healthcare Settings |
Establish processes and procedures to verify the Initial Dose Escalation
is prescribed to initiate treatment.
Establish processes and procedures to verify the dose, as determined by
the certified prescriber, from either the Office Dose Kit or the Daily Dose
Pack is dispensed to enrolled patients for the first dose of each new Up-
Dosing level.
Establish processes and procedures to verify the patient is monitored by
a healthcare provider during and after the Initial Dose Escalation and the
first dose of each new Up-Dosing level.
Establish processes and procedures to verify the patient has injectable
epinephrine before the first dose of each new Up-Dosing level.
Establish processes and procedures to verify the patient was monitored
and previously tolerated the first dose of each new Up-Dosing level
before dispensing a Daily Dose Pack directly to the patient for home use.
Before administering (first
dose)
Verify the Initial Dose Escalation is for the enrolled patient.
Pharmacies that dispense PALFORZIA must:
To become certified to
dispense
Designate an authorized representative to carry out the certification
process and oversee implementation and compliance with the REMS
Program on behalf of the pharmacy.
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 PALFORZIA using the REMS
Program Overview for Pharmacies.
| Program Overview for Pharmacies |
For the Initial Dose Escalation: Establish processes and procedures to
verify that the prescriber is certified, the patient is enrolled, and the
Initial Dose Escalation is only dispensed to certified healthcare settings.
For all Up-Dosing (Daily Dose Pack) prescriptions: Establish processes
and procedures to verify that the patient is enrolled, the prescriber is
certified, and only one dose level is dispensed at a time.
For Daily Dose Packs dispensed directly to a patient by shipping it to
them for home use: Establish processes and procedures to verify with
the prescriber or healthcare setting and document the patient was
monitored and previously tolerated the first dose of each new Up-Dosing
level.
Before dispensing the Initial
Dose Escalation
Verify the prescriber is certified, the patient is enrolled, and the Initial
Dose Escalation is only dispensed to a certified healthcare setting
through the processes and procedures established as a requirement of
the REMS Program.
Before dispensing all Up-
Dosing (Daily Dose Pack)
prescriptions
Verify that the patient is enrolled, the prescriber is certified, and only
one dose level is dispensed at a time through the processes and
procedures established as a requirement of the REMS Program.
Before dispensing a Daily Dose
Pack directly to a patient by
shipping it to them for home
use
Verify with the prescriber or healthcare setting and document that the
patient was monitored and previously tolerated the first dose of each
new Up-Dosing level through the processes and procedures established
as a requirement of the REMS Program.
To maintain certification to
dispense
Have a new Authorized Representative enroll in the REMS Program by
completing the Pharmacy Enrollment Form if the Authorized
Representative changes.
| Pharmacy Enrollment Form |
At all times
Not dispense the Initial Dose Escalation for use outside a certified
healthcare setting.
Not dispense a Daily Dose Pack for the first dose of each new Up-
Dosing level for use outside a certified healthcare setting.
Not distribute, transfer, loan or sell PALFORZIA.
Maintain records that all processes and procedures are in place and are
being followed.
Comply with audits carried out by Aimmune Therapeutics, Inc., or a
third party acting on behalf of Aimmune Therapeutics, Inc., to ensure
that all processes and procedures are in place and are being followed.
Wholesalers-distributors that distribute PALFORZIA must:
To be able to distribute
Establish processes and procedures to ensure that PALFORZIA is
distributed only to certified pharmacies and certified healthcare settings.
Train all relevant staff involved in distributing on the REMS Program
requirements.
At all times
Distribute only to certified pharmacies and healthcare settings.
Maintain records of PALFORZIA distribution.
Comply with audits carried out by Aimmune Therapeutics, Inc., or a
third party acting on behalf of Aimmune Therapeutics, 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.
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
07/26/2024
Modified to align the REMS Document and REMS materials with editorial changes in the United States Package Insert (USPI) to improve clarity regarding the first dose of each “new” Up-Dosing level, and to include the different dosing regimen for the younger age group (patients 1 through 3 years of age).
05/26/2021
Modified the REMS document and REMS materials to:
allow the first dose of each Up-Dosing level to be dispensed from either the Office Dose Kit or the Daily Dose Pack
require prescribers and healthcare settings to report anaphylaxis including suspected cases managed as anaphylaxis to the REMS Program using the Anaphylaxis Adverse Event Reporting Form
07/17/2020
Modified to make minor modifications to the REMS
Website that impact the Healthcare Settings (HCS) Enrollment Form and Prescriber
Enrollment Form sections. The modifications will allow manual entry of the Health Care
Setting Information and Prescriber Information in the required fields.
01/31/2020
REMS Approved
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.
