INTERCEPT Blood System for Platelets -
Indications & Contraindications

 

Indications

Platelet components processed using the INTERCEPT Blood System (“INTERCEPT Platelets”) are indicated for transfusion support of patients requiring platelet transfusions according to clinical practice guidelines. Any type of thrombocytopenia resulting from disease, therapy, or injury can be supported with INTERCEPT Platelets. INTERCEPT treatment may be used as an alternative to gamma irradiation for prevention of transfusion-associated graft-versus-host disease (TA-GVHD). INTERCEPT Platelets are not clinically different from untreated platelets and are infused according to standard platelet infusion methods.

Pathogen Inactivation Claims

In non-clinical studies, the INTERCEPT Blood System for platelets demonstrated inactivation of viruses, bacteria, parasites, and donor leukocytes.

Contraindications

Use of INTERCEPT Platelets is contraindicated in patients with a history of allergic response to amotosalen or psoralens.

Notes to Physicians

Neonatal patients who require platelet transfusions during phototherapy for treatment of hyperbilirubinemia should be treated with phototherapy devices that do not emit light less than 425nm to avoid the theoretical potentiation of an interaction between UVA light and psoralen, which may result in erythema.

While laboratory studies of photochemical treatment processing with the INTERCEPT Blood System for platelets have shown a reduction in the levels of certain viruses, bacteria and parasites, no pathogen inactivation process has been shown to eliminate all pathogens. This pathogen inactivation process is designed as a closed system. Pathogen inactivation does not replace applicable standards that apply to processing in closed and open systems.

 

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