THERAKOS ECP Immunomodulation™

About THERAKOS ECP Immunomodulation™

During THERAKOS ECP Immunomodulation™, patients are connected to the CELLEX™ Photopheresis System that processes a small amount of their white blood cells. Inside the instrument, the cells are treated with a photosensitizing agent called methoxsalen that is then “activated” (turned on) by brief exposure to ultraviolet-A (UVA) light. The treated blood cells are then promptly returned to the patient’s bloodstream.[1] ECP Immunomodulation is done in repeated treatments over a period of time. Each patient’s treatment schedule will vary. The treating healthcare professional will recommend the schedule best suited to the patient’s medical needs.
 
Treatment time varies from patient to patient. In general, with the THERAKOS™ CELLEX™ Photopheresis System an ECP treatment can be completed in approximately 90 minutes.[2
] After treatment, the healthcare professional may want to monitor the patient’s condition for a certain amount of time. Most patients receive the treatment in a lounge chair or hospital bed, during which time they can read or watch television.
 
For patients undergoing ECP, please remember that it is not possible to predict if you will respond or the type and extent of response you will have. Response time may also be different for each person. It is important that you do not give up on the treatment or feel discouraged if you do not see results quickly. Your response may be different depending on the state of your immune system, the severity of your disease, and how frequently you receive the treatment. Improvement usually happens gradually.

 

Please see Important Safety Information.

 

THERAKOS ECP Immunomodulation™ Safety

Healthcare professionals have been administering THERAKOS ECP Immunomodulation™ treatments to patients since 1987. Serious side effects of ECP Immunomodulation are rare and are primarily related to a temporary drop in blood pressure due to minor changes in blood volume during the treatment. Patients are monitored by healthcare professionals during treatment for low blood pressure. Other possible side effects such as fever or skin redness usually go away within a day.
 
If you are due to undergo THERAKOS ECP Immunomodulation™, ask your healthcare professional if you have questions about the safety of this treatment.
 
THERAKOS ECP Immunomodulation™ is a sterile process

  • Single-use, sterile kit is discarded after each treatment

  • All phases of the treatment take place during one session: Blood collection and separation

  • Treatment of isolated white blood cells with medication and UVA light

  • Return of treated cells to the body

  • THERAKOS™ Photopheresis Systems are the world’s only approved, fully-integrated systems for administering ECP Immunomodulation.

  • Since the isolated white blood cells are treated with medication while they are in the THERAKOS™ Photopheresis Systems, the amount of medication that is used for treatment is extremely low.

Safety in children has not been established.
 
POSSIBLE SIDE EFFECTS OF PHOTOPHERESIS
 
Methoxsalen sterile solution, the medicine used in photopheresis, can make the patient more sensitive to sunlight for about 24 hours after the treatment. Taking the right precautions reduces the risk for cataracts (a condition of the eyes) or serious sunburns. If you are receiving ECP Immunomodulation therapy, you should protect your 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 direct or indirect sunlight

 
Other possible side effects include fatigue, a temporary increase in itchiness, or a slight fever or redness appearing 6 to 8 hours after treatment. Having treatments more frequently than labelling recommendations may result in a decrease in red blood cells (anaemia). As with any procedure that involves a needle puncture, there is a small risk of infection and pain at the needle puncture site. Talk to your healthcare professional about any concerns you have about potential risks associated with THERAKOS ECP Immunomodulation™.

ECP stands for Extracorporeal Photopheresis, a treatment that works with a patient’s own immune cells to modulate immune function.[3-5]

Click the link below
 to learn more about a
CELLEX Photopheresis procedure

References:

  1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28 Suppl 1:1-37.

  2. Bisaccia E, et al. Br J Dermatol. 2009;161(1):167-169.

  3. Marshall SR. Nat Clin Pract Oncol. 2006 Jun;3(6):302-314.

  4. Bruserud Ø, et al. Cancer Immunol Immunother. 2014;63(8):757-777.

  5. Hart JW, et al. Ther Adv Hematol. 2013;4:320-334.

 

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© 2018 Mallinckrodt. Mallinckrodt Pharmaceuticals is a registered business name of Mallinckrodt plc, which is registered in Ireland as a public limited company with registration number 522227 and has its registered office at Damastown, Mulhuddart, Dublin 15, Ireland.