About Photopheresis | Photopheresis Systems

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 THERAKOS photopheresis procedure.

THERAKOS Photopheresis is a therapy designed to reduce the skin symptoms associated with cutaneous T-cell lymphoma, also referred to as CTCL.¹

This treatment is thought to help restore your body’s natural ability to maintain a balanced immune system.³ More information can be found on this web site in the Patient Brochure.

As shown on the slide as step 1, at the beginning of a THERAKOS Photopheresis treatment session an intravenous line, or IV, is inserted into your arm. Blood is then withdrawn by the Photopheresis instrument.¹

This blood enters the photopheresis instrument, which separates the white blood cells that are involved in the immune response from the other components of your blood - this is shown as step 2. The white blood cells remain in the instrument.¹

In step 3, a medicine is added to the separated white blood cells. In step 4, the cells are exposed to ultraviolet-A, or UVA, light, which activates the medicine. The treated white blood cells are then returned to your body (shown as step 5).¹

This drawing shows the entire process of THERAKOS Photopheresis at a glance. In step 1, the instrument draws a small amount of your blood. In step 2, the blood is separated. In step 3, the medicaton is added to the white blood cells. In step 4 the medication is activated by UVA light. Finally, in step 5, the treated white blood cells are returned to your body.⁴

Photopheresis is performed in repeated treatments intended to reduce your symptoms over time. Each patient’s treatment schedule and length of treatment varies and will be determined by your doctor.¹ Response times can vary between patients, so it is important to follow your doctor’s instructions.¹

THERAKOS Photopheresis has an established safety profile with more than a half-million patient treatments.¹ Serious side effects are rare, and include fever, worsening of skin redness, and a drop in blood pressure during treatment.⁵ These side effects usually resolve within one day. Photopheresis does not cause suppression of the immune system.^2,3 Ask your doctor if you have questions about the safety of this treatment.

• Extracorporeal photopheresis 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.
• Serious side effects are rare (<.01%) and are primarily related to a drop in blood pressure during treatment¹
  • Side effects include fever and worsening of skin redness, and typically resolved within one day.¹

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.