UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS® CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.
INDICATIONS AND USAGE
UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS® CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.
CAUTION: READ THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM’S OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.
UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS CELLEX Photopheresis System. Please consult the CELLEX Operator's Manual before using this product.
For the THERAKOS® CELLEX® Photopheresis Procedure:
The THERAKOS CELLEX Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP®), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other forms of treatment.
CONTRAINDICATIONS
UVADEX is contraindicated in:
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
For the THERAKOS® CELLEX® Photopheresis Procedure:
INDICATIONS
The THERAKOS CELLEX Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other forms of treatment.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
The THERAKOS CELLEX Photopheresis System is not designated, sold, or intended for use except as indicated.
Certain underlying medical conditions contraindicate THERAKOS Photopheresis, including patients:
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
Please see accompanying Full Prescribing Information, including the BOXED WARNING for UVADEX, and see the THERAKOS Photopheresis System Operator’s Manual.
CAUTION: READ THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM’S OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.
UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS CELLEX Photopheresis System. Please consult the CELLEX Operator's Manual before using this product.
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