Contraindications, Warnings and Precautions

Contraindications, Warnings and Precautions:

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

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.

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

INDICATIONS FOR USE

• 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.