Photopheresis and Methoxsalen
Photopheresis and methoxsalen
Using photopheresis and methoxsalen
All elements of photopheresis equipment should be certified to work together to deliver photopheresis – and this includes the need for photopheresis equipment to be certified to work specifically with methoxsalen, or any other drug being used. Specifically, the directive states that, ‘if devices are intended to administer medicinal products (ie methoxsalen) they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned.’ A supplier should provide drug labelling to demonstrate that the drug has been specifically approved (or is pending approval) for use with the instrument and treatment kit.
The THERAKOS™ CELLEX™ and THERAKOS™ UVAR XTS™ Photopheresis Systems have both been tested and approved for use with methoxsalen.25
Ensuring safety and quality
Johnson & Johnson Medical Limited methoxsalen is manufactured using a purification process to ensure drug impurities are removed or reduced to meet EU standards for a parenteral drug. THERAKOS™ methoxsalen is approved for use with the THERAKOS™ CELLEX™ and the THERAKOS™ UVAR XTS™ Photopheresis Systems. The THERAKOS™ CELLEX™ and THERAKOS™ UVAR XTS™ Photopheresis Systems also use optimised drug concentrations.33 All THERAKOS™ methoxsalen is tested by THERAKOS™ and an independent EU regulatory test laboratory to help ensure safety and quality.
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