Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose (2)
AAUDIENCE: Patient, Health Professional, Pharmacy, Gastroenterology, Rheumatology
The trial is studying two different doses of tofacitinib (5 mg twice daily, which is the currently approved dose for RA, and a higher, 10 mg twice daily dosage) in comparison to a TNF blocker. In RA, the body attacks its own joints, causing pain, swelling, and loss of function. An interim analysis of the trial's results found an increased occurrence of blood clots and of death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF blocker. In 2017, we approved the medicine to treat patients with a second condition that causes joint pain and swelling, PsA, who did not respond well to methotrexate or other similar medicines. In 2018, we approved tofacitinib to treat ulcerative colitis, which is a chronic, inflammatory disease affecting the colon.
RECOMMENDATION:
Patients should tell your health care professionals if you have a history of blood clots or heart problems, and talk to them about any questions or concerns. Stop taking tofacitinib and seek emergency medical attention right away if you experience any unusual symptoms, including those that may signal a blood clot such as:
• Sudden shortness of breath
• Chest pain that worsens with breathing
• Swelling of a leg or arm
• Leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm
Do not stop taking tofacitinib without first talking to your health care professional, as doing so can worsen your condition.
Healthcare professionals should discontinue tofacitinib and promptly evaluate patients with symptoms of thrombosis. Counsel patients about the risks and advise them to seek medical attention immediately if they experience any unusual symptoms, including those of thrombosis listed above. Reserve tofacitinib to treat ulcerative colitis for patients who have failed or do not tolerate tumor necrosis factor (TNF) blockers. Avoid tofacitinib in patients who may have a higher risk of thrombosis. When treating ulcerative colitis, use tofacitinib at the lowest effective dose and limit the use of the 10 mg twice daily dosage to the shortest duration needed (See Additional Information for Health Care Professionals for more recommendations).
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
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
該試驗比較TNF抑制劑以及兩種不同劑量的tofacitinib（目前核准的RA劑量：5 mg每日兩次以及較高劑量10 mg每日兩次）。該試驗的期中分析結果發現，使用tofacitinib 10 mg每日兩次的病人，比使用tofacitinib 5 mg每日兩次或使用TNF抑制劑治療的病人，出現較高的血栓和死亡的機率。
2017年美國FDA核准此藥的第二種適應症：對methotrexate或其他類似藥物反應不佳的PsA。2018年美國FDA核准此藥治療潰瘍性結腸炎。
若病人有血栓或心臟病相關的病史，應告知醫療專業人員，並與其討論任何問題或疑慮。若出現任何以下異常症狀，請立即停止服用tofacitinib並尋求緊急醫療協助，包括可能為血栓信號的症狀，例如：1.突然呼吸急促。2.因呼吸而惡化的胸痛。3.腳或手臂腫脹。4.腿部疼痛或壓痛、腫脹疼痛的腿部或手臂之皮膚變紅或變色。建議病人在與醫療專業人員討論之前，請勿自行停用tofacitinib，因為可能會造成病人病情惡化。
醫療專業人員應停用tofacitinib，並立即評估有血栓形成症狀的病人。為病人提供有關風險的建議，並告知病人若出現任何異常症狀，包括上面列出的血栓形成症狀，應立即就醫。治療潰瘍性結腸炎時應保留tofacitinib用於治療失敗或不耐受TNF抑制劑的病人。對可能具有較高血栓形成風險的病人應避免使用tofacitinib。治療潰瘍性結腸炎時，使用最低有效劑量的tofacitinib，並限制每日兩次服用10 mg劑量至所需的最短時間（更多建議請參閱醫療專業人員的其他資訊）。
（全文完）
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
[Posted 07/26/2019]
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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