Methoxsalen

What it is used for

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.

Side effects, and when to stop

Side effects of photopheresis (UVADEX ® used with THERAKOS ® Photopheresis Systems) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%). In study CTCL 3 (UVADEX ® ), six serious cardiovascular adverse experiences were reported in five patients (5/51, 10%). Five of these six events were not related to photopheresis and did not interfere with the scheduled photopheresis treatments. One patient (1/51, 2%) with ischemic heart disease had an arrhythmia after the first day of photopheresis that was resolved the next day. Six infections were also reported in five patients. Two of the six events were Hickman catheter infections in one patient, which did not interrupt the scheduled photopheresis. The other four infections were not related to photopheresis and did not interfere with scheduled treatments.

Who should not take it

• UVADEX ® (methoxsalen) Sterile Solution is contraindicated in patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, other psoralen compounds or any of the excipients. Patients possessing a specific history of a light sensitive disease state should not initiate methoxsalen therapy. Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism.
• UVADEX ® Sterile Solution is contraindicated in patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses.
• Patients should not receive UVADEX ® if they have any contraindications to the photopheresis procedure.

Other medicines and interactions

See Warnings Section.

Storing it

UVADEX ® (methoxsalen) Sterile Solution 20 mcg/mL in 10 mL amber glass vials (NDC 64067-216-01), and cartons of 12 vials (NDC 64067-216-01). One vial of 10 mL contains 200 micrograms methoxsalen. The drug product must be stored between 59°F (15°C) and 86°F (30°C)

Drug dosage and administration

Each UVADEX ® treatment involves collection of leukocytes, photoactivation, and reinfusion of photoactivated cells. UVADEX ® (methoxsalen) Sterile Solution is supplied in 10 mL vials containing 200 mcg of methoxsalen (concentration of 20 mcg/mL). The THERAKOS ® CELLEX ® Photopheresis System Operator's Manual should be consulted before using this product. UVADEX ® should not be diluted. The contents of the vial should be injected into the THERAKOS ® CELLEX ® Photopheresis System immediately after being drawn up into a syringe. Do not inject directly into patients. The UVADEX ® vial is for single use only. Any UVADEX ® that is not used during a procedure should be immediately discarded. UVADEX ® can adsorb onto PVC and plastics, therefore only THERAKOS ® CELLEX ® photopheresis procedural kits supplied for use with the instrument should be used to administer this medicinal product. Once UVADEX ® is drawn into a plastic syringe it should be immediately injected into the photoactivation bag. UVADEX ® exposed to a plastic syringe for more than one hour should be discarded.

During treatment with the THERAKOS ® CELLEX ® Photopheresis System, the dosage of UVADEX ® for each treatment will be calculated according to the treatment volume.

• The prescribed amount of UVADEX ® should be injected into the recirculation bag prior to the Photoactivation Phase using the formula: