Generic Name and Formulations:
Methoxsalen 20mcg/mL; sterile soln.
Indications for UVADEX:
Extracorporeal administration with the UVAR XTS or CELLEX Photopheresis System in the palliative treatment of skin manifestations of cutaneous T-cell lymphoma that is unresponsive to other forms of treatment.
Consult UVAR XTS or CELLEX Photopheresis System Operator's Manual before administering. Give on 2 consecutive days every 4 weeks for minimum of 7 treatment cycles (6 months). Calculate dose per treatment based on treatment volume: Dose (mL) = treatment volume x 0.017. Accelerated treatment schedule: see full labeling.
Idiosyncratic reactions to psoralen compounds. History of light sensitive disease. Lupus erythematosus. Porphyria cutanea tarda. Erythropoietic protoporphyria. Variegate porphyria. Xeroderma pigmentosum. Albinism. Aphakia.
Should be used only by trained and experienced physicians.
Exposure to sun or UV light may cause actinic degeneration, skin burning, cataracts; wear UVA-absorbing, wrap-around sunglasses and cover exposed skin (or use sunblock: SPF ≥15) for 24hrs after treatment. Basal cell carcinomas; monitor. Possible thromboembolic events in treatment of graft-versus-host disease (not approved use). Pregnancy (Cat.D); avoid. Nursing mothers.
Increased photosensitivity with anthralin, coal tar, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides, sulfonamides, tetracyclines, thiazides, certain organic staining dyes (eg, methylene blue, toluidine blue, rose bengal, methyl orange).
Hypotension secondary to changes in extracorporeal volume.
Single-use vials (10mL)—12