Adult Dosing
Note: Therapy should be given extracorporeally with the UVAR photopheresis system only. (Not for parenteral administration).
Cutaneous T-cell lymphoma
- Inject 10 mL (200 mcg) into the photoactivation bag during the first buffy coat collection cycle
- Collect total of 740 mL (240 mL of buffy coat, 300 mL of plasma, and 200 mL of normal saline priming fluid) at the end of six cycles
- Reinfused the cells after photoactivation
Notes:
- Schedule of Treatment
- Normal treatment schedule: Two consecutive days q4 wks for a minimum of seven treatment cycles
- Accelerated treatment schedule:
- If skin score increases from baseline (during 4th treatment cycle), increase frequency to two consecutive treatments q2 wks
- If skin score improves by 25% after four consecutive weeks, resume the regular treatment schedule
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Methoxsalen 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 UVAR Photopheresis System [US Black Box Warning]
- When methoxsalen is used in combination with photopheresis, refer to the UVAR* System Operator’s Manual for specific warnings, cautions, indications, and instructions related to photopheresis [US Black Box Warning]
- Use cautiously in patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents
- After administration of therapy avoid exposure to sunlight or ultraviolet radiation which may result in premature aging of the skin
- Diligently observe and treat patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinomas
- If the recommended dosage of methoxsalen is exceeded or precautions not followed, serious burns from either UVA or sunlight (even through window glass) can occur
- Patients who use proper eye protection after PUVA therapy appear to have no increased risk of developing cataracts
- Patients with history of arsenic exposure, previous radiation therapy or Grenz ray therapy should be observed for signs of carcinoma
Cautions: Use cautiously in
- Lactation
- History of basal cell carcinomas
- Serious burns from either UVA or sunlight
Supplemental Patient Information
- Wear UVA-absorbing, wrap-around sunglasses and cover exposed skin or use a sunblock (SP 15 or higher) for twenty-four (24) hour period following treatment with methoxsalen, whether exposed to direct or indirect sunlight in the open or through a window glass
Pregnancy Category:D
Breastfeeding: Safety unknown. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.
