UK consensus statement on safe clinical prescribing of Bexarotene for patients with cutaneous T-cell lymphoma.

Abstract

Background: Bexarotene is a synthetic retinoid from the subclass of retinoids called rexinoids which selectively activate retinoid X receptors. It has activity in cutaneous T-cell lymphoma and has been approved by the European Medicines Agency since 1999 for treatment of the skin manifestations of advanced stage (IIB-IVB) cutaneous T-cell lymphoma in adult patients refractory to at least one systemic treatment. In vivo bexarotene produces primary hypothyroidism which may be managed with thyroxine replacement. It also affects lipid metabolism typically resulting in raised triglycerides which requires prophylactic lipid modification therapy. Effects on neutrophils, glucose and liver function may also occur. These side effects are dose dependent and may be controlled with corrective therapy or dose adjustments. Objectives: To produce a UK statement outlining a bexarotene dosing schedule and monitoring protocol to enable bexarotene prescribers to deliver bexarotene safely for optimal effect. Methods: Leaders from UK supraregional centres have produced this consensus statement after a series of meetings and review of the literature. Results: The statement outlines a bexarotene dosing schedule and monitoring protocol. This gives instruction on monitoring and treating thyroid, lipid, liver, blood count, creating kinase, glucose and amylase abnormalities. This statement also includes algorithms for a bexarotene protocol and lipid management which may be used in the clinical setting. Conclusion: Clinical prescribing of bexarotene for patients with cutaneous T-cell lymphoma requires careful monitoring to allow bexarotene to be given safely at optimal dose.