About THERAKOS™ Photopheresis treatment for healthcare professionals

Hello, my name is Dr. Larisa Geskin. I am the Director of Cutaneous Oncology and Photopheresis Unit at the University of Pittsburgh School of Medicine. This presentation will discuss the procedure involved in performing THERAKOS™ photopheresis.

THERAKOS™ Photopheresis is indicated for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma, or CTCL, that are unresponsive to other forms of treatment.¹

CTCL is a non-Hodgkin's lymphoma characterized by the malignant proliferation of CD4+ T lymphocytes that infiltrate the skin. Treatment with THERAKOS™ Photopheresis is thought to act in several ways in order to restore the body's natural ability to maintain a balanced immune system.^34141,2,3 More information can be found on this web site.

During THERAKOS™ Photopheresis, peripheral intravenous access is usually obtained, although alternative devices including indwelling and temporary catheters, subcutanous ports, central venous catheters, implanted devices, or AV fistulas or shunts may be used in certain situations if they meet specified requirements. Whole blood is collected in the photopheresis instrument, and the blood is centrifuged to separate the leukocyte-enriched blood fraction (also called the buffy coat) from the red blood cells and plasma. The leukocyte-enriched blood fraction remains in the instrument while the other blood components are immediately returned to the patient (step 2).

In the treatment bag, the leukocyte-enriched blood fraction is directly injected with 20 micrograms/mL of UVADEX. The medicated blood fraction is then exposed to an automatically calculated amount (approximately 1.5 Joules/cm2) of UVA light. Activated UVADEX covalently binds and cross-links DNA, leading to apoptosis of treated cells.² The treated cells are then reinfused into the patient.

Treatment with THERAKOS™ Photopheresis may take several months to see a response. Normally, patients should receive treatment on 2 successive days each month for 6 months. An “adequate” response is at least a 25% improvement in skin scores within the first 8 treatments that is maintained for at least 4 weeks. For patients who fail to show an “adequate response” after 8 treatments, an accelerated treatment frequency may be used, with treatment schedules increased to 2 successive days every 2 weeks for 3 months. In clinical trials, patients who achieved a positive response were maintained at a schedule of 2 successive days of treatment every 5 weeks for at least 3 months. If initial responses continue to be maintained, frequency may be decreased gradually or discontinued entirely in some cases. If a patient has achieved no response or a less than an “adequate response” after 20 treatments, clinical judgment should be used to decide if photopheresis should be discontinued.

THERAKOS™ Photopheresis has an established safety profile. More than a half-million treatments have been given to patients since 1987.1 Serious side effects are rare, and are primarily related to hypotension secondary to changes in extracorporeal volume of greater than 1%.7 They include fever and worsening of skin redness, and resolve within one day. Photopheresis does not cause immunosuppression and is not associated with an increased risk of opportunistic infections, secondary malignancies, lipid or endocrine abnormalities.

• Extracorporeal photopheresis therapy can make patients more sensitive to sunlight for about 24 hours after the treatment.
• Patients should take the right precautions to reduce the risk for cataracts (a condition of the eye) or serious sunburns.
• It is suggested to protect the eyes and skin by taking the following simple but very important precautions for 24 hours after each treatment:
• Avoid sunlight as much as possible, even indirect sunlight coming through a window
• Wear sunscreen SPF 15 or higher when exposed to sunlight (both outdoors and indoors)
• Wear UVA-protective, full-coverage sunglasses when exposed to sunlight
• Other possible side effects are usually minor and go away within a day.
• These could include fatigue, a temporary increase in itchiness, or a slight fever or redness appearing 6 to 8 hours after treatment.
• As with any procedure that involves a needle puncture, there is a small risk of getting an infection.

Please see the complete Prescribing Information and Important Safety Information on this web site.

References

1. Data on file, Therakos, Inc.
2. McKenna KE, Whittaker S, Rhodes LE, et al. Evidence-based practice of photopheresis 1987-2001: a report of a workshop of the British Photodermatology Group and the UK Skin Lymphoma Group. Br J Dermatol. 2006;154:7-20.
3. Suchin KR, Cassin M, Washko R, et al. Extracorporeal photochemotherapy does not suppress T- or B-cell responses to novel or recall antigens. J Am Acad Dermatol. 1999;41(6):980-986.
4. THERAKOS^™ CELLEX^™ Photopheresis System Operator's Manual. Rev. 3.0-1460436.
5. UVADEX^™ (methoxsalen) Sterile Solution Prescribing Information. Manufactured by Ben Venue Laboratories, Bedford ,OH 44146-0568 for Therakos, A Johnson & Johnson Company, Exton, PA, 19341.