Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS 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.
POSTMARKETING Adverse reactions reported from postmarketing experience include nausea, dysgeusia, photosensitivity reaction, pyrexia and hypersensitivity reactions including anaphylaxis and rash.
WARNINGS Concomitant Therapy Patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal and methyl orange may be at greater risk for photosensitivity reactions with UVADEX ® .
Carcinogenicity, Mutagenesis, Impairment of Fertility Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic.
In a prospective study of 1380 patients given PUVA therapy for psoriasis, 237 patients developed 1422 cutaneous squamous cell cancers.
This observed incidence of cutaneous carcinoma is 17.6 times that expected for the general population.
Previous cutaneous exposure to tar and UVB treatment, ionizing radiation or arsenic increased the risk of developing skin carcinomas after PUVA therapy.
Like all medications, Uvadex can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: