羅米司亭與艾曲波帕藥品說明書doc(編輯修改稿)
2025-08-11 06:00 本頁面
【文章內容簡介】 查全血細胞計數(shù)(CBCs)，血小板計數(shù)至少4周。PROMACTA劑量過量可能增高血小板計數(shù)至一個產生血栓形成/血栓栓塞并發(fā)癥水平。PROMACTA可能增高血液病惡性病的風險，特別是在骨髓增生異常綜合征患者。用PROMACTA治療調整劑量期時每周監(jiān)查CBC，包括血小板計數(shù)和外周血圖片，然后確定穩(wěn)定劑量PROMACTA后每月。因為肝毒性和其它風險，只能從有限制計劃獲得PROMACTA。為納入有限制計劃可電話聯(lián)系18779 PROMACTA。不良反應：最常見不良反應(發(fā)生大于接受PROMACTA1例患者和相比安慰劑PROMACTA發(fā)生率較高)是： 惡心、嘔吐、月經過多、肌肉痛、感覺異常、白內障、消化不良、瘀斑、血小板減少、ALT/AST增加和結膜出血。黑框警告：肝毒性風險PROMACTA可能引起肝毒性:開始PROMACTA治療前測定血清丙氨酸轉氨酶(AST)，和膽紅素，調整劑量期每2周1次和確定穩(wěn)定劑量后每月1次。如膽紅素升高，進行分次。評價異常血清肝檢驗與在3至5天重復測試。如證實異常，每周監(jiān)查血清肝檢驗直至異常消失、穩(wěn)定或回至基線水平。中斷PROMACTA如ALT水平增加至 ≥正常(ULN)上限3倍是：● 進展，或● 持續(xù) ≥4 周，或● 伴直接膽紅素增高，或● 伴肝損傷臨床癥狀或肝代償失調證據(jù)。藥物相互作用：艾曲波帕是OATP1B1轉運蛋白的抑制劑。緊密監(jiān)查患者過量暴露于OATP1B1底物(如，羅蘇伐他汀(rosuvastatin))藥物征象和癥狀并考慮減低這些藥物的劑量。多價陽離子(如、鐵、鈣、鋁、鎂、硒、和鋅)顯著減低艾曲波帕的吸收；必須不在任何含多價陽離子藥物如抗酸藥、乳制品、和礦物補充劑4小時內服用PROMACTA。在特殊人群中的應用：妊娠：可能引起胎兒傷害。納入妊娠患者在PROMACTA妊娠注冊。哺乳母親：應作出決策中斷PROMACTA或哺乳，考慮PROMACTA對母親的重要性。FDA has approved Promacta tablets (eltrombopag, from GlaxoSmithKline) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have been unresponsive to corticosteroids, immunoglobulins or splenectomy. This indication was based on results from two shortterm studies and one ongoing longterm study of patients with chronic ITP. In order to assure the safe use of Promacta, healthcare providers and patients must be enrolled in GlaxoSmithKline39。s Promacta Cares program.Promacta is an oral thrombopoietin (TPO) receptor agonist.What is Promacta?Promacta is a oncedaily oral medicine that activates the thrombopoietin (TPO) receptor. Activation of the TPO receptor causes platelets to increase, relieving conditions of low platelets known as thrombocytopenia.Pr
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