Welcome to the PALFORZIA REMS (Risk Evaluation and Mitigation Strategy) Program
The PALFORZIA REMS (Risk Evaluation and Mitigation Strategy) Program is a safety program that manages the risk of anaphylaxis associated with PALFORZIA®. The PALFORZIA REMS Program is required by the Food and Drug Administration (FDA) to ensure the potential benefits of PALFORZIA outweigh its risks.
Learn about Healthcare Setting Certification.
Learn about Prescriber Certification.
Learn about Pharmacy Certification.
Learn about Patient Enrollment.
GOALS
The goal of the PALFORZIA REMS Program is to mitigate the risk of anaphylaxis associated with PALFORZIA by:
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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 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 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 Up-Dosing level, the need for continued dietary peanut avoidance, and how to recognize the signs and symptoms of anaphylaxis.
If you have questions about the PALFORZIA REMS Program or need help with certification or enrollment,
call 1-844-PALFORZ (1-844-725-3679)
Monday-Friday, 8:00am – 8:00pm ET
To learn more about the serious risks associated with PALFORZIA, please refer to the Prescribing Information including Boxed Warning and the Medication Guide.
Indication
PALFORZIA is indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older.