Therakos Cellex Photopheresis System

Safety advisory – risk of blood clots

27 February 2018

Consumers and health professionals are advised that the TGA is investigating a safety concern regarding the Therakos Cellex Photopheresis System.

Therakos Cellex Photopheresis System is an extracorporeal photopheresis (ECP) device. ECP involves a patient’s blood passing through a device that separates out one particular part that is then treated with a photosensitising agent and irradiated with specified wavelengths of light to achieve an effect. The treated blood is then returned to the patient’s body. Therakos Cellex Photopheresis System can be used to treat cutaneous T-cell lymphoma (CTCL) and patients with graft versus host disease (GVHD), as well as other conditions.

The US Food and Drug Administration (FDA) has published an alert for health professionals regarding reports of venous thromboembolism (also known as blood clots), including pulmonary embolism (blood clots that become lodged in the lungs), in patients who had recently used Therakos Cellex Photopheresis System. Included in the alert are two reports in which the patients died. However, it is not clear if pulmonary embolism was the cause of death in these cases.

Since 2009 the TGA has received 13 reports associated with Therakos Cellex Photopheresis System. One report is related to a severe allergic reaction that may have been caused by the device, but was more likely due to a drug used in the procedure. All other reports relate to components of the photopheresis system either breaking, leaking or missing.

The TGA is continuing to monitor this issue and encourages consumers and health professionals to report any suspected problems associated with Therakos Cellex Photopheresis System, especially any cases of venous thromboembolism (including deep vein thrombosis) and pulmonary embolism.

Information for consumers

If you or someone you provide care for has been treated with Therakos Cellex Photopheresis System, please be aware of this issue.

If you have any questions or concerns about this issue, please speak to your health professional.

Information for health professionals

If you are treating a patient who has used Therakos Cellex Photopheresis System, please be aware of this issue.

It is recommended that you educate these patients regarding the signs and symptoms of pulmonary embolism and deep vein thrombosis.

If your patient has any further questions or concerns, refer them to their haematologist/oncologist.

Information for haematologists/oncologists

If you use Therakos Cellex Photopheresis System, please be aware of this issue and take it into consideration when discussing benefits and potential risk of this treatment with patients.

It is recommended that you educate these patients regarding the signs and symptoms of pulmonary embolism and deep vein thrombosis.

Also, refer to the device labelling regarding considerations for anticoagulation therapy in conjunction with this treatment. Use clinical judgment in adjusting an individual patient's dosage.

Please report any suspected problems associated with Therakos Cellex Photopheresis System, especially any cases of venous thromboembolism (including deep vein thrombosis) and pulmonary embolism. This will assist the TGA to continue to monitor the safety of this device.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.