CONTRAINDICATIONS
Contraindicated for preparation of platelet or plasma components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens.

Contraindicated for preparation of platelet or plasma components 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 with 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 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 into the blood components must be weighed against the benefits of therapeutic transfusion.

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.

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Resources

INT3140B – Plasma (P) Semi-Integrated Set Package Insert

INT2540B – Platelets Dual Storage (DS) Semi-Integrated Set Package Insert

INT2140B – Platelets Small Volume (SV) Semi-Integrated Set Package Insert

INT2240B – Platelets Large Volume (LV) Semi-Integrated Set Package Insert

INT3130 – Plasma (P) Package Insert

INT2130B – Platelets Small Volume (SV) Package Insert

INT2230B – Platelets Large Volume (LV) Package Insert

INT2530B – Platelets Dual Storage (DS) Package Insert

WARNINGS AND CONTRAINDICATIONS