U.K. consensus statement on safe clinical prescribing of bexarotene for patients with cutaneous T-cell lymphoma

Br J Dermatol. 2013 Jan;168(1):192-200. doi: 10.1111/bjd.12042. Epub 2012 Dec 3.

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 (CTCL) and has been approved by the European Medicines Agency since 1999 for treatment of the skin manifestations of advanced-stage (IIB-IVB) CTCL 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 U.K. statement outlining a bexarotene dosing schedule and monitoring protocol to enable bexarotene prescribers to deliver bexarotene safely for optimal effect.

Methods: Leaders from U.K. supraregional centres produced this consensus statement after a series of meetings and a review of the literature.

Results: The statement outlines a bexarotene dosing schedule and monitoring protocol. This gives instructions on monitoring and treating thyroid, lipid, liver, blood count, creatine kinase, glucose and amylase abnormalities. The 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 CTCL requires careful monitoring to allow safe administration of bexarotene at the optimal dose.

Publication types

  • Consensus Development Conference
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Amylases / blood
  • Anticarcinogenic Agents / administration & dosage*
  • Anticarcinogenic Agents / adverse effects
  • Bexarotene
  • Blood Cell Count
  • Blood Glucose / metabolism
  • Cholesterol, HDL / deficiency
  • Clinical Protocols
  • Drug Administration Schedule
  • Female
  • Fenofibrate / therapeutic use
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use
  • Hypercholesterolemia / prevention & control
  • Hypertriglyceridemia / chemically induced
  • Hypertriglyceridemia / prevention & control
  • Hypolipidemic Agents / therapeutic use
  • Liver Function Tests
  • Lymphoma, T-Cell, Cutaneous / drug therapy*
  • Musculoskeletal Pain / chemically induced
  • Pancreatitis / chemically induced
  • Pregnancy
  • Pregnancy Complications / chemically induced
  • Pregnancy Complications / prevention & control
  • Skin Neoplasms / drug therapy*
  • Tetrahydronaphthalenes / administration & dosage*
  • Tetrahydronaphthalenes / adverse effects
  • Thyrotropin / deficiency
  • Thyroxine / therapeutic use

Substances

  • Anticarcinogenic Agents
  • Blood Glucose
  • Cholesterol, HDL
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Hypolipidemic Agents
  • Tetrahydronaphthalenes
  • Thyrotropin
  • Bexarotene
  • Amylases
  • Thyroxine
  • Fenofibrate