IMPORTANT SAFETY INFORMATION FOR THERAKOS™ PHOTOPHERESIS PROCEDURE
The THERAKOS™ CELLEX™ Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the
presence of the photoactive drug 8-methoxypsoralen (8-MOP), of extracorporeally circulating leukocyte-enriched
blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) and systemic
Certain underlying medical conditions contraindicate THERAKOS Photopheresis, including:
Patients who cannot tolerate extracorporeal volume loss during the leukocyte enrichment phase
Patients exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds
Patients with coagulation disorders or who have had previous splenectomy
WARNINGS & PRECAUTIONS
THERAKOS Photopheresis treatments should always be performed in locations where standard medical emergency equipment
is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure.
MR-Unsafe: Do not expose the device to a magnetic resonance (MR) environment. The device
may present a risk of projective injury, and thermal injury and burns may occur. The device may generate
artifacts in the MR image, or may not function properly.
Thromboembolic Events: Thromboembolic events, including pulmonary embolism and deep vein
thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD), an indication not
approved in Canada. Special attention to adequate anticoagulation is advised when treating patients with GvHD.
Concomitant Therapy: When prescribing and administering THERAKOS Photopheresis for patients
receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease
activity that may be caused by abrupt withdrawal of previous therapy.
Hypotension may occur during any treatment involving extracorporeal circulation. Monitor the patient closely
during the entire treatment.
Transient pyretic reactions, 37.7-38.9ºC (100-102ºF), have been observed in some patients within 6-8 hours of
reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the
Treatment frequency exceeding labeling recommendations may result in anemia.
Venous access carries a small risk of infection and pain.
IMPORTANT SAFETY INFORMATION FOR METHOXSALEN STERILE SOLUTION USED IN CONJUNCTION WITH THERAKOS™ CELLEX PHOTOPHERESIS SYSTEM
Methoxsalen Sterile Solution is contraindicated in:
Patients exhibiting idiosyncratic reactions to psoralen compounds
Patients with aphakia
Patients possessing a specific history of a light-sensitive disease state
SERIOUS WARNINGS AND PRECAUTIONS
Concomitant Therapy: Exercise care in treating patients who are receiving concomitant
therapy (either topically or systemically) with known photosensitizing agents.
Carcinogenicity: Oral administration of methoxsalen followed by cutaneous UVA exposure
(PUVA therapy) is carcinogenic. Patients exhibiting multiple basal cell carcinomas or having a history of
basal cell carcinoma should be diligently observed and treated.
Teratogenicity: Methoxsalen may cause fetal harm when given to a pregnant woman. Women
undergoing photopheresis should be advised to avoid becoming pregnant.
Cataractogenicity: Patients should be told emphatically to wear UVA absorbing, wrap-around
sunglasses for twenty-four (24) hours after methoxsalen treatment, any time they are exposed to direct or
indirect sunlight and whether they are outdoors or exposed through a window.
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements. Published online September 2019.
https://www.iso.org/standard/62085.html. Accessed March 16, 2021.
International Organization for Standardization. ISO 13485:2003 Medical Devices – Quality Management Systems – Requirements
for Regulatory Purposes. Published online July 2003. https://www.iso.org/standard/36786.html. Accessed March 16, 2021.
WELCOME TO THERAKOSHCP.CA
This website is intended for use by Canadian healthcare professionals only.
You are now leaving the Mallinckrodt site and moving to an external, third-party website independently
operated and not managed by Mallinckrodt Pharmaceuticals. Mallinckrodt assumes no responsibility for the
site. The content provided on the third-party website is meant for informational purposes only, is not endorsed
by or under the control of Mallinckrodt, and is not meant to replace a physician’s medical advice. Mallinckrodt
has no responsibility or liability for and makes no representations or warranties whatsoever about any third-party content.
If you do not wish to leave this site, click CANCEL. Or click OK to continue.