Note: Please refer to the appropriate product labeling for a complete list of warnings and precautions.
CAUTION: READ THE THERAKOS™ UVAR XTS® or THERAKOS™ CELLEX® Photopheresis SYSTEMS’ OPERATOR'S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.
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 with the THERAKOS™ UVAR XTS® or THERAKOS™ CELLEX® Photopheresis Systems.
Methoxsalen Sterile Solution is indicated for extracorporeal administration with the THERAKOS™ UVAR XTS® or THERAKOS™ CELLEX® Photopheresis System Instrument in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.
PHOTOSENSITIVITY: Methoxsalen Sterile Solution is contraindicated in patients exhibiting idiosyncratic reactions to psoralen compounds. Patients possessing a specific history of a light-sensitive disease state should not initiate methoxsalen therapy.
Methoxsalen Sterile Solution is contraindicated in patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of a lens.
Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.
Skin burns or premature aging may occur if protective precautions are not taken.
Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. Because the dose with liquid methoxsalen ECP is about 200 times less than with PUVA therapy and the skin is not exposed to high cumulative doses of UVA light, the risk of developing skin cancer following this therapy may be lower.
Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinoma should be diligently observed and treated.
Methoxsalen may cause fetal harm when given to a pregnant woman. Women undergoing photopheresis should be advised to avoid becoming pregnant.
Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.
Safety in children has not been established.
Side effects of photopheresis were primarily related to hypotension secondary to changes in extracorporeal volume (>1%).
Please review the prescribing information for oral methoxsalen if that is used in conjunction with THERAKOS™ Photopheresis therapy.
The THERAKOS™ UVAR XTS® Photopheresis System Instrument / THERAKOS™ CELLEX® Photopheresis System Instrument 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.
The THERAKOS™ UVAR XTS® or THERAKOS™ CELLEX® Photopheresis Systems are not designated, sold or intended for use except as indicated. Certain underlying medical conditions contraindicate THERAKOS™ Photopheresis, including patients who cannot tolerate extracorporeal volume loss during the leukocyte-enrichment phase, patients exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds, and patients with coagulation disorders.
THERAKOS™ Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure.
Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension.
Transient pyretic reactions, 37.7-38.9oC (100-102 oF), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.
Treatment frequency exceeding labeling recommendations may result in anemia.
Venous access carries a small risk of infection and pain.
Before prescribing THERAKOS™ Photopheresis, please read the physician Prescribing Information. The Patient Information is also available.
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Indications
Methoxsalen Sterile Solution is indicated for extracorporeal administration with the THERAKOS™ UVAR XTS® or 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.
Methoxsalen should be used only by physicians who have special training in the THERAKOS™ UVAR XTS® or THERAKOS™ CELLEX® Photopheresis Systems. Methoxsalen is contraindicated in patients exhibiting idiosyncratic reactions to psoralen compounds, patients with a specific history of a light sensitive disease, or patients with aphakia.
THERAKOS™ Photopheresis is not appropriate for patients who cannot tolerate extracorporeal volume loss or shifts, or patients with coagulation disorders. See Important Safety Information for additional details.
