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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 dispensed and distributed to certified healthcare settings 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

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
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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