Anaphylaxis

• 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)] .