INTERCEPT Blood System for Plasma -
Indications & Contraindications
INTERCEPT Plasma is indicated for support of patients requiring plasma transfusions or therapeutic plasma exchange, according to clinical practice guidelines. Clinical trials in patients have demonstrated that plasma treated with the INTERCEPT Blood System was well tolerated and retained therapeutic efficacy comparable to conventional fresh frozen plasma. INTERCEPT Plasma may be used to treat single coagulation factor or antithrombotic protein deficiencies for which no concentrates are available, as well as multiple coagulation factor and antithrombotic protein deficiencies. INTERCEPT Plasma may also be used for plasma exchange for thrombotic thrombocytopenic purpura (TTP). INTERCEPT treatment may be used as an alternative to gamma irradiation for prevention of transfusion-associated graft-versus-host disease (TA-GVHD). Plasma photochemically treated with the INTERCEPT Blood System may be stored and transfused according to standard methods for frozen plasma.
Pathogen Inactivation Claims
In non-clinical studies, the INTERCEPT Blood System for plasma demonstrated inactivation of viruses, bacteria, parasites, and donor leukocytes.
Use of INTERCEPT Plasma is contraindicated in patients with a history of allergic response to amotosalen or psoralens.
Notes to Physicians
Neonatal patients who require plasma transfusion during phototherapy for treatment of hyperbilirubinemia should be treated with phototherapy devices that do not emit light less than 425 nm to avoid the theoretical potentiation of an interaction between UVA light and amotosalen, which may result in erythema.
While laboratory studies of photochemical treatment processing with the INTERCEPT Blood System for plasma have shown significant reduction in the infectivity of certain viruses, bacteria and parasites, no pathogen inactivation process has been shown to eliminate the infectivity of 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.