Peanut (Arachis hypogaea) Allergen Powder-dnfp powder
- PALFORZIA can cause anaphylaxis, which may be life-threatening and can occur at any time during PALFORZIA therapy [see WARNINGS AND PRECAUTIONS (5.1)] .
- Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use [see WARNINGS AND PRECAUTIONS (5.1)] .
- Do not administer PALFORZIA to patients with uncontrolled asthma [see CONTRAINDICATIONS (4)] .
- Dose modifications may be necessary following an anaphylactic reaction [see DOSAGE AND ADMINISTRATION (2.5)] .
- Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dosing level, for at least 60 minutes [see DOSAGE AND ADMINISTRATION (2.4)] .
- Because of the risk of anaphylaxis, PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS [see WARNINGS AND PRECAUTIONS (5.2)] .
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information
Updated June 2020