UVADEX Solution for injection Ref.[11072] Active ingredients: Methoxsalen

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:

TREATMENT VOLUME × 0.017 = mL of UVADEX for each treatment

Example: Treatment volume of 240 mL × 0.017 = 4.1 mL of UVADEX

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 months).

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.

In the event of overdosage, the patient should be kept in a darkened room for at least 24 hours.

The drug product must be stored between 59°F (15°C) and 86°F (30°C).