This site provides INTERCEPT product information for Health Care Professionals in the United States.

INTERCEPT PLATELETS

Delivers Value

INTERCEPT® Platelets Deliver Value and Operational Efficiencies

Efficiencies gained and transfusion-transmitted infection (TTI) risk reduction with platelets treated with the INTERCEPT Blood System Pathogen Reduction System (INTERCEPT Platelets) may translate to economic benefits:

Receipt of transfusion-ready platelets with the ability to use INTERCEPT Platelets in place of certain tests and/or procedures, such as bacterial detection, CMV serology, and irradiation^1-5
Reduced TTI risk* may save costs on associated treatments and investigations

Avoidance of false positives and associated recalls, may save time, resources, and platelet units
Minimized platelet contamination risk, which could jeopardize critical procedures such as stem cell transplantations

Tested vs. INTERCEPT graph

Also, with PR platelets, the need for irradiation prior to issue is no longer present. This allows us to distribute platelets more quickly to patients in need.

Dr. Shannon Walker, MD

Assistant Professor, Transfusion Medicine & Pediatric Hematology/Oncology
Department of Pathology, Microbiology & Immunology and Pediatrics
Vanderbilt University Medical Center

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*There is no pathogen reduction process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19, and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process. For a full list of pathogens, see Package Insert.

References:

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry. US FDA; December 2020.
Recommendations for Reducing the Risk of Transfusion-Transmitted Malaria”, FDA Guidance for Industry. December 2022.
“Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis”, FDA Guidance for Industry. May 2019.
Harm SK, et al. Transfusion. 2018 Apr; 58(4):938-942.
Ruby KN, et al. Transfusion. 2018 Jul; 58(7):1665-1669.

INTERCEPT® Blood System for Platelets Pathogen Reduction System

INTENDED USE

The INTERCEPT Blood System for Platelets is intended to be used for ex vivo preparation of pathogen-reduced Amicus apheresis platelet components suspended in 65% PAS-3/35% plasma, and Trima apheresis platelet components suspended in 100% plasma in order to reduce the risk of transfusion-transmitted infection (TTI), including sepsis, and as an alternative to gamma irradiation for prevention of transfusion-associated graft versus host disease (TA-GVHD).

CONTRAINDICATIONS

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

Contraindicated for preparation of platelet 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 are approved for use in the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet components. No other source of UVA light may be used. Please refer to the Operator’s Manual for the INT100 Illuminator. Discard any platelet 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.

INTERCEPT® Blood System for Cryoprecipitation for the manufacturing of Pathogen Reduced Cryoprecipitated Fibrinogen Complex

INTENDED USE

Pathogen Reduced Cryoprecipitated Fibrinogen Complex is indicated for:

Treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency.
Control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor (vWF) are not available.
Second-line therapy for von Willebrand disease (vWD).
Control of uremic bleeding after other treatment modalities have failed.

Limitations of Use: Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used for replacement of factor VIII.

CONTRAINDICATIONS

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

Contraindicated for preparation of blood 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 the INTERCEPT Blood System for Cryoprecipitation is approved for use to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex.

For management of patients with vWD or factor XIII deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used if recombinant or specific virally-inactivated factor preparations are available. In emergent situations, if recombinant or specific virally-inactivated factor preparations are not available, Pathogen Reduced Cryoprecipitated Fibrinogen Complex may be administered.