Everolimus

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Aphthous stomatitis: 4 case reports Four heart transplant recipients developed severe aphthous stomatitis after mycophenolate mofetil was switched to everolimus [route not stated] in their immunosuppressive regimens. An 18-year-old boy started receiving everolimus (dosage adjusted to achieve a trough drug level of 5–10 ng/mL). One week later, he developed painful confluent aphthous stomatitis on his tongue and oral cavity. At the time, he was receiving everolimus 0.75mg twice daily. On admission, he had difficulty swallowing and he had a trough everolimus concentration of 4.4 ng/mL. Everolimus was identified as a likely factor to cause stomatitis and his target trough everolimus concentrations were reduced to 3–6 ng/mL. One month later, his stomatitis resolved. A 17-year-old girl developed painful aphthous oral stomatitis 3 weeks after switching to everolimus (dosage adjusted to achieve target trough concentrations). At the time, she was receiving everolimus 1mg twice daily and her trough concentration of everolimus was 7.22 ng/mL. Everolimus was suspected as a likely cause of stomatitis, and her target trough concentrations of everolimus were reduced to 3–6 ng/mL. Two weeks later, her stomatitis resolved. A 43-year-old man developed painful aphthous oral stomatitis with difficulty swallowing 1 week after switching to everolimus. At the time, he was receiving everolimus 1mg in the morning and 0.75mg in the evening. His trough concentration of everolimus was 7.6 ng/mL. Everolimus was suspected as a likely cause of stomatitis, and his target trough concentrations of everolimus were reduced to 3–6 ng/mL. His stomatitis resolved 2 weeks later. A 32-year-old man started receiving everolimus. One week later, he developed aphthous stomatitis in his mouth and had difficulty swallowing. Additionally, he reported pain in both knee joints, and a low fever. He was receiving everolimus 0.75mg twice daily at the time, and his trough drug concentration was 3.71 ng/mL. Everolimus was discontinued and mycophenolate mofetil was re-started. One week later, his fever resolved and his joint pain had gone. One month after everolimus withdrawal, his stomatitis completely resolved. Author comment: ". . . in the Japanese population, [everolimus] can induce severe stomatitis–even at therapeutic trough levels." Sasaoka T, et al. Common occurrence of everolimus-associated aphthous stomatitis in Japanese heart transplant recipients. Transplantation Proceedings 42: e3700-3703, No. 9, Nov 2010. Available from: URL: http://dx.doi.org/10.1016/ 803047846 j.transproceed.2010.06.023 - Japan

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Reactions 15 Jan 2011 No. 1334