UVADEX^Ò (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the UVAR Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.

Each UVADEX^Ò treatment involves collection of leukocytes, photoactivation, and reinfusion of photoactivated cells. UVADEX^Ò (methoxsalen) Sterile Solution is supplied in 10 mL vials containing 200 mcg of methoxsalen (concentration of 20 mcg/mL). During each photopheresis treatment performed with UVADEX^Ò , 10 mL (200mcg) of UVADEX^Ò is injected directly into the photoactivation bag during the first buffy coat collection cycle. At the end of six cycles, a total of 740 mL (240 mL of buffy coat, 300 mL of plasma, and 200 mL of normal saline priming fluid) is collected and mixed with the 200 mcg of UVADEX^Ò present in the photoactivation bag. After photoactivation the cells are reinfused. The UVAR^Ò Photopheresis System Operator's Manual should be consulted before using this product.

Frequency/Schedule of Treatment

Normal Treatment Schedule: UVADEX^Ò 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^Ò beyond six months or using a different schedule provides additional benefit. In study C.C. 3, 15 of the 17 responses were seen within six months of treatment and only two patients responded to treatment after six months.

UVADEX^Ò (methoxsalen) Sterile Solution 20 mcg/mL in 10 mL vials (NDC Methoxsalen-Methoxsalen-xx), and cartons of 12 vials (NDC Methoxsalen-Methoxsalen-xx).

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

REFERENCES

1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.
2. AMA Council Report, Guidelines for Handling of Parenteral Antineoplastics. JAMA, 1985; 2.53 (11): 1590-1592.
3. National Study Commission on Cytotoxic Exposure- Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
4. Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia, 1983; 1:426-428.
5. Jones, RB, et al. Safe Handling of Chemotherapeutic Agents: A Report from The Mount Sinai Medical Center. CA- A Cancer Journal for Clinicians, 1983;(Sept/Oct) 258-263.
6. American Society of Hospital Pharmacists Technical Assistance Bulletin of Handling Cytotoxic and Hazardous Drugs. Am J. Hosp Pharm, 1990;47:1033-1049.
7. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines), AM J. Health-Syst Pharm, 1996; 53: 1669-1685.

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