UVADEX® (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
DOSAGE AND ADMINISTRATION
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® UVAR XTS® or 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® UVAR XTS® or
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® UVAR XTS® or 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® UVAR XTS® or 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
Photactivation Phase Using The Formula
TREATMENT VOLUME X 0.017 = mL of UVADEX® for each treatment
Example: Treatment volume of 240 mL X 0.017 = 4.1 mL of
Frequency/Schedule Of Treatment
Normal Treatment Schedule: Treatment is given on two
consecutive days every four weeks for a minimum of seven treatment cycles (six
Accelerated Treatment Schedule
If the assessment of the patient during the fourth
treatment cycle (approximately three months) reveals an increased skin score
from the baseline score, the frequency of treatment may be increased to two
consecutive treatments every two weeks. If a 25% improvement in the skin score
is attained after four consecutive weeks, the regular treatment schedule may
resume. Patients who are maintained in the accelerated treatment schedule may
receive a maximum of 20 cycles. There is no clinical evidence to show that
treatment with UVADEX® beyond six months or using a different
schedule provides additional benefit. In study CTCL 3, 15 of the 17 responses
were seen within six months of treatment and only two patients responded to
treatment after six months.
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)
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Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood
Avenue, Boston, Massachusetts 02115.
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Manufactured by Patheon Manufacturing Services LLC,
Greenville, NC 27834 For Therakos, Inc., 10 North High Street, Suite 300, West
Chester, PA 19380-3014 USA. Revised : Jan 2018