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[Posted 07/26/2019]
Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose (1)
AUDIENCE: Patient, Health Professional, Pharmacy, Gastroenterology, Rheumatology
ISSUE: FDA has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of Xeljanz, Xeljanz XR (tofacitinib), which is used in patients with ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines. We approved these changes, including adding our most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis (RA) that examined a lower and this higher dose of the medicine.
BACKGROUND: Tofacitinib works by decreasing the activity of the immune system; an overactive immune system contributes to RA, PsA, and ulcerative colitis. Tofacitinib was first approved in 2012 to treat adult patients with RA who did not respond well to the medicine methotrexate. When FDA first approved tofacitinib in 2012, FDA required a post-marketing clinical trial in patients with RA on background methotrexate, to evaluate the risk of heart-related events, cancer, and infections.
美國FDA審查一正在進行中的臨床試驗之期中分析資料，該試驗為研究類風濕性關節炎（rheumatoid arthritis, RA）病人使用低劑量和高劑量的tofacitinib之相關安全性。根據此期中報告，美國FDA發布tofacitinib新的用藥安全警訊，Xeljanz、Xeljanz XR（tofacitinib）以10 mg每日兩次用於治療潰瘍性結腸炎患者，可能會增加血栓和死亡風險，並請廠商於加框警語中放入相關資訊。此外，美國FDA另核准tofacitinib治療潰瘍性結腸炎，僅限用於某些使用其他藥物仍無法有效治療或出現嚴重副作用的病人。
Tofacitinib的作用機轉為降低免疫系統的活性。過度活化的免疫系統會導致RA、乾癬性關節炎（Psoriatic arthritis，PsA）和潰瘍性結腸炎。美國FDA於2012年核准tofacitinib治療對methotrexate反應不佳的成人RA病人，同時美國FDA要求需對曾使用過methotrexate的RA病人進行上市後臨床試驗，以評估心臟相關事件，癌症和感染的風險。
（待續）
相關訊息與連結請參考FDA網址：
https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-due-increased-risk-blood-clots-and-death?utm_campaign=FDA%20Medatch%20Xeljanz%2C%20Xeljanz%20XR%20%28tofacitinib%29%3A%20Drug%20Safety%20Communication&utm_medium=email&utm_source=Eloqua
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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