Addressing Bacterial Contamination – FDA Issues Final Guidance

WARNINGS AND CONTRAINDICATIONS

CONTRAINDICATIONS: Contraindicated for preparation of platelets or plasma intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelets or plasma intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen. WARNINGS AND PRECAUTIONS: Only INTERCEPT Processing Sets for platelets or plasma are approved for use in the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet or plasma components. No other source of UVA light may be used. Please refer to the Operator’s Manual for the INT100 Illuminator. Discard any platelet or plasma components not exposed to the complete INT100 illumination process. Tubing components and container ports of the INTERCEPT Blood System for Platelets contain polyvinyl chloride (PVC). Di(2-ethylhexyl)phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released to into the blood components must be weighed against the benefits of therapeutic transfusion. PLATELETS: Pulmonary events: Acute Respiratory Distress Syndrome (ARDS). INTERCEPT processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS). An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients for signs and symptoms of ARDS. PLASMA - Amotosalen-treated plasma may cause the following adverse reaction: Cardiac Events. In a randomized controlled trial of therapeutic plasma exchange (TPE) for TTP, five patients treated with INTERCEPT Blood System processed plasma and none with conventional plasma had adverse events in the cardiac system organ class (SOC) reported. These events included angina pectoris (n=3), cardiac arrest (n=1), bradycardia (n=1), tachycardia (n=1) and sinus arrhythmia (n=1). None of these events resulted in documented myocardial infarction or death. Monitor patients for signs and symptoms of cardiac events during TPE for TTP.