Approved Risk Evaluation and Mitigation Strategies (REMS)

Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
BLA #125696
REMS last update: 05/26/2021



What is the purpose of the REMS?

The goal of the PALFORZIA REMS Program is to mitigate the risk of anaphylaxis associated with PALFORZIA by:

  1. Ensuring that healthcare providers who prescribe and healthcare settings that dispense and administer PALFORZIA are educated on the following:
    1. the risk of anaphylaxis associated with the use of PALFORZIA
    2. the Initial Dose Escalation and first dose of each Up-Dosing level must only be administered to patients in a healthcare setting equipped to monitor patients, and to identify and manage anaphylaxis.
  2. Ensuring that the Initial Dose Escalation and the first dose of each Up-Dosing level of PALFORZIA are only dipsensed and distributed to certified healthcare sttings and only administered to patients in healthcare settings
  3. 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 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.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare providers who prescribe Palforzia must:

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.
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 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 Up-Dosing level
  • Assess the patient’s tolerability of the previous dosing level and appropriateness of continuing the 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 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 Up-Dosing level.

Patients who are prescribed Palforzia must:

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 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 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 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:

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 review the Education Program for Healthcare Settings.
    | Education Program for Healthcare Settings |
  • 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 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 Up-Dosing level.
  • Establish processes and procedures to verify the patient has injectable epinephrine before the first dose of each Up-Dosing level.
  • Establish processes and procedures to verify the patient was monitored and previously tolerated the first dose of the 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.
During treatment; before the first dose of each 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 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 the 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.
    | Anaphylaxis Adverse Event Reporting 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.

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 review the REMS Program Overview for Pharmacies.
    | REMS Program Overview for Pharmacies |
  • 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.
    | REMS 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 the 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 the 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 an 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.

Material Name Material Name Link
Anaphylaxis Adverse Event Reporting Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Anaphylaxis_Adverse_Event_Reporting_Form.pdf
Education Program for Healthcare Settings (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Education_Program_for_Healthcare_Settings.pdf
Healthcare Setting Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Healthcare_Setting_Enrollment_Form.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Patient_Enrollment_Form.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Pharmacy_Enrollment_Form.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_Prescriber_Enrollment_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_REMS_Full.pdf
REMS Program Overview for Pharmacies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_REMS_Program_Overview_for_Pharmacies.pdf
REMS Program Website (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2021_05_26_REMS_Program_Website.pdf

What updates have been made to the REMS?

Date Summary of change
05/26/2021 Modified the REMS document and REMS materials to:
  1. allow the first dose of each Up-Dosing level to be dispensed from either the Office Dose Kit or the Daily Dose Pack
  2. 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.

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