Important Notice: PALFORZIA® REMS Program and Product Withdrawal
PALFORZIA® REMS Program
The PALFORZIA® Risk Evaluation and Mitigation Strategy (REMS) Program is being discontinued following the withdrawal of PALFORZIA from the U.S. market.
As a result:
- No new enrollments or certifications for pharmacies, wholesale distributors, health care professionals, and health care settings.
- No new patients may initiate treatment with PALFORZIA.
- PALFORZIA is no longer available for commercial distribution in the United States.
Information for Current or Former PALFORZIA Patients
Patients should not discontinue or modify any treatment plan without first consulting their healthcare provider. Patients with questions regarding prior PALFORZIA treatment or the ongoing management of peanut allergy should contact their healthcare provider.
Patients experiencing a medical emergency should seek immediate medical attention or call 911.
Information for Healthcare Providers
Healthcare providers with questions regarding the PALFORZIA REMS Program or the withdrawal of PALFORZIA may contact Medical Information:
1-844-PALFORZ (1-844-725-3679)
[email protected]
Adverse Event Reporting
Anaphylaxis adverse events (including suspected cases managed as anaphylaxis) must be reported to the REMS. The PALFORZIA REMS Anaphylaxis Adverse Event Reporting Form can be found at https://www.stagrallergy.com/wp-content/uploads/10-PALFORZIA-REMS_Anaphylaxis-Adverse-Event-Reporting-Form-v5.0-26Jul2024.pdf.
Greer Laboratories, Inc.
Telephone: 1-844-PALFORZ (1-844-725-3679)
Fax: 1-844-285-2013
[email protected]
Adverse events may also be reported to the FDA MedWatch Program:
Online: https://www.fda.gov/medwatch
Telephone: 1-800-FDA-1088
Additional Information
Additional information regarding the PALFORZIA REMS Program and withdrawal of PALFORZIA is available through Medical Information.