Apremilast
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Apremilast Various toxicities following an off-label use: 5 case reports In a retrospective case series, 5 patients [3 women and 2 men] aged 37–66 years were described, who developed nausea, loose stool, headache, loose stool, weight loss or diarrhoea during off-label treatment with apremilast for recurrent aphthous stomatitis [route and time to reactions onsets not stated; not all outcomes stated]. The patients, who had recurrent aphthous stomatitis, were treated with various medications for the duration of 3–28 months. The patients were refractory to previous therapies. Hence, the patients started receiving off-label treatment with apremilast as per standard induction scheme for 5 days (on day 1: 10mg once, on day 2: 10mg twice daily, on day 3: 10mg in morning and 20mg in evening, on day 4: 20mg in morning and 20mg in evening and on day 5: 20mg in morning and 30mg in evening), followed by 30mg twice daily. During apremilast therapy, all the patients developed treatment-related adverse events, which included mild nausea and loose stool (3 patients), mild headache, loose stool and severe nausea (1 patient) or headache, weight loss and mild diarrhoea (1 patient). The patients had received treatment with apremilast for 2–24 months. Hence, apremilast therapy was discontinued in one patient, who had headache, weight loss and mild diarrhoea, and the other patient, who developed mild headache, loose stool and severe nausea, was treated with psyllium husk powder [Metamucil], metoclopramide and ondansetron. The remaining three patients recovered after 1–4 weeks. Author comment: "Written informed consent was provided by all the patients for off-label treatment with apremilast". "All the authors vouch for the . . . reporting of adverse events". Kolios AGA, et al. Apremilast in Treatment-Refractory Recurrent Aphthous Stomatitis. New England Journal of Medicine 381: 1975-1977, No. 20, 14 Nov 2019. Available from: URL: http://doi.org/10.1056/NEJMc1901987 803441224 Switzerland
0114-9954/19/1784-0001/$14.95 Adis © 2019 Springer Nature Switzerland AG. All rights reserved
Reactions 21 Dec 2019 No. 1784
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