瑞戈非尼合理用药要点
瑞戈非尼(Stivarga)说明书
瑞戈非尼（Stivarga）
【规格】
40mg/片
【适应症】
用于不能通过手术切除以及使用其它已上市药物治疗无效的晚期胃肠道间质瘤(GIST)患者治疗。
【禁忌症】
对本品有严重超敏反应者禁用。
【用法用量】
160mg口服。
每天1次每28天疗程，与食物服用。
【不良反应】
最常见不良反应(≥30%)是乏力/疲乏、减低食欲和食物摄入量、手足皮肤反应(HFSR)、腹泻、口腔粘膜炎、体重减轻、感染、高血压和发音困难。
【注意事项】
1.出血：对严重或威胁生命出血永久终止用药。
2.皮肤学毒性：减低或终止Stivarga取决于皮肤学毒性的严重程度和持久性。
3.高血压：对严重或不能控制的高血压暂时或永久终止Stivarga。
4.心脏缺血和梗死：拒给Stivarga对新或急性心脏缺血/梗死和只有急性缺血事件解决后恢复。
5.可逆性后部白质脑病综合征(RPLS)：终止Stivarga。
6.胃肠道穿孔或瘘管：终止Stivarga。
7.伤口愈合并发症：术前停止Stivarga，在伤口裂开患者中终止。
8.胚胎胎儿毒性：可能致胎儿危害，劝告妇女对胎儿潜在风险。
新型肿瘤药物临床应用指导原则(2019年版)
新型抗肿瘤药物临床应用指导原则（2019年版）目录第一部分新型抗肿瘤药物临床应用指导原则抗肿瘤药物临床应用的基本原则一、病理组织学确诊后方可使用 (01)二、靶点检测后方可使用 (02)三、严格遵循适应证用药 (04)四、体现患者治疗价值 (04)五、特殊情况下的药物合理使用……………………………………………………………六、重视药物相关性不良反应………………………………………………………………抗肿瘤药物临床应用管理0506一、医疗机构建立抗肿瘤药物临床应用管理体系 (06)二、抗肿瘤药物临床应用实行分级管理 (09)三、细胞或组织病理学诊断 (10)四、培训、评估和督查 (11)第二部分各系统肿瘤的药物临床应用指导原则呼吸系统肿瘤用药一、吉非替尼 (13)二、厄洛替尼 (14)三、埃克替尼 (15)四、阿法替尼…………………………………………………………………………………五、达可替尼…………………………………………………………………………………15 17六、奥希替尼 (19)七、克唑替尼…………………………………………………………………………………八、阿来替尼…………………………………………………………………………………九、塞瑞替尼 (20)2122十、贝伐珠单抗 (23)十一、重组人血管内皮抑制素 (25)十二、安罗替尼 (26)十三、纳武利尤单抗…………………………………………………………………………十四、帕博利珠单抗…………………………………………………………………………十五、依维莫司………………………………………………………………………………27 29 32消化系统肿瘤用药一、索拉非尼…………………………………………………………………………………二、瑞戈非尼 (34)35三、仑伐替尼 (36)四、曲妥珠单抗 (36)五、阿帕替尼 (38)六、伊马替尼 (38)七、舒尼替尼 (39)八、依维莫司 (40)九、西妥昔单抗 (42)十、贝伐珠单抗 (43)十一、呋喹替尼 (45)血液肿瘤用药一、伊马替尼 (46)二、达沙替尼 (48)三、尼洛替尼 (49)四、伊布替尼 (49)五、利妥昔单抗 (51)六、西达本胺 (53)七、硼替佐米…………………………………………………………………………………八、信迪利单抗………………………………………………………………………………九、卡瑞利珠单抗……………………………………………………………………………54 56 59十、来那度胺 (63)十一、沙利度胺..........................................................................................十二、伊沙佐米 (64)65十三、芦可替尼 (67)泌尿系统肿瘤用药一、依维莫司 (68)二、索拉非尼 (69)三、舒尼替尼 (70)四、阿昔替尼 (70)五、培唑帕尼…………………………………………………………………………………六、帕博利珠单抗……………………………………………………………………………七、纳武利尤单抗 (72)7374乳腺癌用药一、曲妥珠单抗 (77)二、拉帕替尼…………………………………………………………………………………三、吡咯替尼…………………………………………………………………………………四、帕妥珠单抗………………………………………………………………………………五、哌柏西利 (79)80 82 85皮肤及软组织肿瘤用药一、伊马替尼 (87)二、维莫非尼…………………………………………………………………………………三、帕博利珠单抗……………………………………………………………………………四、特瑞普利单抗 (87)88 90五、依维莫司 (92)头颈部肿瘤用药一、尼妥珠单抗………………………………………………………………………………二、索拉非尼…………………………………………………………………………………生殖系统肿瘤用药一、奥拉帕利 (94)9596第一部分新型抗肿瘤药物临床应用指导原则为规范新型抗肿瘤药物临床应用，提高肿瘤合理用药水平，保障医疗质量和医疗安全，维护肿瘤患者健康权益，特制定新型抗肿瘤药物临床应用指导原则。
消化系统肿瘤用药临床应用指导原则(2021年版)
新型抗肿瘤药物临床应用指导原则（2021年版）消化系统肿瘤用药一、索拉非尼 (48)二、瑞戈非尼 (49)三、仑伐替尼 (50)四、多纳非尼 (51)五、阿替利珠单抗 (51)六、信迪利单抗 (53)七、卡瑞利珠单抗 (55)八、替雷利珠单抗 (57)九、帕博利珠单抗 (59)十、曲妥珠单抗 (61)H■•一、阿帕替尼 (62)十二、纳武利尤单抗 (63)十三、维迪西妥单抗 (66)十四、伊马替尼 (67)十五、舒尼替尼 (69)十六、阿伐替尼 (70)十七、瑞派替尼 (71)十八、依维莫司 (72)十九、索凡替尼 (74)二十、贝伐珠单抗 (75)二十一、西妥昔单抗 (77)二十二、吠喳替尼 (79)发生4级或复发性3级不良反应，虽然进行治疗调整但仍持续存在2级或3级不良反应，应永久性停用卡瑞利珠单抗。
严重者或诊断存疑者可由消化科、风湿科、皮肤科、呼吸科、肿瘤科等组成的免疫不良反应MDT进行会诊。
5.本品在N65岁的老年患者中应用数据有限，建议在医师的指导下慎用，如需使用，无需进行剂量调整。
不建议在妊娠期间使用本品治疗。
目前本品尚无针对中重度肾功能损伤患者的研究数据，中重度肾功能损伤患者不推荐使用，轻度肾功能损伤患者应在医师指导下慎用本品，如需使用，无需进行剂量调整。
目前本品尚无针对中重度肝功能损伤患者的研究数据，中重度肝功能损伤患者不推荐使用，轻度肝功能损伤患者无需进行剂量调整。
6.在使用本品之前应避免使用全身性糖皮质激素或其他免疫抑制剂，因为这些药物可能会影响本品的药效学活性及疗效。
但在本品开始给药后，可使用全身性糖皮质激素或其他免疫抑制剂治疗免疫介导性不良反应。
7.反应性毛细血管增生症的处理：在接受本品治疗的患者中，70%〜80%发生反应性毛细血管增生症。
反应性毛细血管增生症，大多发生在体表皮肤，少数可见于口腔黏膜、鼻腔黏膜以及眼睑结膜。
发生于皮肤的反应性毛细血管增生症, 初始多表现为体表鲜红色点状物，直径W2nmi,随着用药次数增加，病变范围可逐渐增大，多为结节状，也有斑片状，颜色鲜红或暗红，需观察临床症状和体征。
瑞格非尼说明书
【特别警示】本药可引起严重甚至致命的肝毒性，用药前和用药期间应监测肝功能。
如出现肝毒性，根据其严重程度和持续时间采取适当措施(包括暂停给药、减量和停药)。
(FDA药品说明书-瑞格非尼片)【药物名称】中文通用名称：瑞格非尼英文通用名称：Regorafenib其他名称：Stivarga。
【药理分类】西药 > 肿瘤用药 > 抗肿瘤药 > 抗信号转导药【临床应用】CFDA说明书适应症尚未收集到相关资料。
其他临床应用参考1.用于治疗先前接受过含氟嘧啶、奥沙利铂、伊立替康的化疗和抗血管内皮生长因子(VEGF)、抗表皮生长因子受体(EGFR)(KRAS野生型)治疗的转移性结直肠癌(CRC)。
(FDA批准适应症)2.用于治疗先前接受过伊马替尼和舒尼替尼治疗的局部晚期、无法切除或转移性胃肠道间质细胞瘤(GIST)。
(FDA批准适应症)临床指南胃肠道间质瘤诊治指南解读肢体软组织肉瘤临床诊疗专家共识的解读中国胃肠间质瘤诊断治疗共识(2013年版)【用法与用量】国外用法用量参考成人·常规剂量·CRC、GIST1.口服给药一次160mg，一日1次，连用21日，28日为一疗程。
持续用药直至疾病进展或出现不可耐受的毒性。
·肾功能不全时剂量轻度肾功能损害[肌酐清除率(Ccr)为60-89ml/min]者无需调整剂量；中度肾功能损害(Ccr为30-59ml/min)者用药的研究资料有限；尚无重度肾功能损害或终末期肾病患者用药的研究资料。
·肝功能不全时剂量轻度(Child-Pugh分级为A级)或中度肝功能损害(Child-Pugh分级为B级)者无需调整剂量；尚无重度肝功能损害(Child-Pugh分级为C级)者用药的研究资料，故不推荐使用。
·毒性状态时剂量1.出现以下情况时，应暂停给药：(1)复发的或降低剂量后7日内无改善的2级手-足皮肤反应(HFSR)；3级HFSR(暂停给药至少7日)。
瑞戈非尼片说明书
核准日期：2017年3月22日 修改日期：2017年12月5日瑞戈非尼片说明书请仔细阅读说明书并在医师指导下使用。
【药品名称】通用名称：瑞戈非尼片 商品名称：Stivarga® 拜万戈® 英文名称：Regorafenib Tablets 汉语拼音：Ruigefeini Pian【成份】主要成份：瑞戈非尼化学名称：4-[4-({[4-氯-3-(三氟甲基)苯基]氨基甲酰}氨基)-3-氟苯氧基]-N-甲基吡啶-2-甲酰胺一水合物化学结构式：分子式：C 21H 15ClF 4N 4O 3•H 2O 分子量：500.83 【性状】本品为浅粉色椭圆形薄膜衣片。
【适应症】1. 适用于治疗既往接受过以氟尿嘧啶、奥沙利铂和伊立替康为基础的化疗, 以及既往接受过或不适合接受抗VEGF 治疗、 抗EGFR 治疗（RAS 野生型）的转移性结直肠癌（mCRC ）患者。
2. 既往接受过甲磺酸伊马替尼及苹果酸舒尼替尼治疗的局部晚期的、无法手术切除的或转移性的胃肠道间质瘤（GIST ）患者。
3. 既往接受过索拉非尼治疗的肝细胞癌（HCC ）患者。
【规格】警告：肝脏毒性•在临床研究中发生了严重的、有时是致命性的肝脏毒性; •在治疗前及治疗中进行肝功能监测；•在使用瑞戈非尼片治疗中，可根据肝功检测或肝细胞坏死所表现出来的肝脏毒性的严重程度和持续性，暂停后降低剂量或停药。
40mg【用法用量】瑞戈非尼应由在抗癌治疗给药方面有经验的医生开具。
推荐剂量推荐剂量为160mg（4片，每片含40mg 瑞戈非尼），每日一次，于每一疗程的前21天口服，28天为一疗程。
服用方法瑞戈非尼片应在每天同一时间，在低脂早餐（脂肪含量30%）后随水整片吞服。
患者不得在同一天服用两剂药物以弥补（前一天）漏服的剂量。
如果服用瑞戈非尼后出现呕吐，同一天内患者不得再次服药。
治疗时间应持续治疗直至患者不能临床受益或出现不可耐受的毒性反应。
剂量调整及特殊使用说明基于个人的安全性及耐受性考虑，可能需要中断给药或降低剂量。
瑞戈非尼
瑞戈非尼片(Stivarga)说明书与价格商品名称: Stivarga通用名称: 瑞戈非尼片英文名称: regorafenib汉语拼音: Ruigefeinipian【产品价格】40mg×28片×3瓶:30000元/盒【适应症】Stivarga是一种激酶抑制剂适用于既往曾用基于氟嘧啶，奥沙利铂-和伊立替康化疗，一种抗-VEGF治疗，和，如KRAS野生型，一种抗-EGFR治疗过的转移结肠直肠癌(CRC)患者的治疗。
【用法用量】（1）推荐剂量：160 mg口服，每天1次每28天疗程的头21天。
（2）与食物服用Stivarga(一种低脂肪早餐)。
【不良反应】最常见不良反应(≥30%)是乏力/疲乏，减低食欲和食物摄入量，手足皮肤反应(HFSR) [掌足红肿(PPE)]，腹泻，口腔粘膜炎，体重减轻，感染，高血压，和发音困难。
【注意事项】（1）出血：对严重或威胁生命出血永久终止Stivarga。
（2）皮肤学毒性：瑞格非尼片价格中断和然后减低或终止Stivarga取决于皮肤学毒性的严重程度和持久性。
（3）高血压：对严重或不能控制的高血压暂时或永久终止Stivarga。
（4）o1533缺血和梗死：拒给Stivarga对新或急性o1533缺血/梗死和只有急性缺血事件解决后恢复。
（5）可逆性后部白质脑病综合征(RPLS)：终止Stivarga。
（6）胃肠道穿孔或瘘管：终止Stivarga。
（7）伤口愈合并发症：瑞格非尼片哪里卖术前停止Stivarga。
在伤口裂开患者中终止。
（8）胚胎胎儿毒性：可能致胎儿危害。
劝告妇女对胎儿潜在风险。
【规格】40mg，28片/盒。
【贮藏】遮光，密封保存。
【生产企业】德国拜耳医药公司【提示】。
瑞戈非尼说明书
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use STIVARGA safely and effectively. See full prescribing information for STIVARGA.STIVARGA® (regorafenib) tablets, for oral useInitial U.S. Approval: 2012WARNING: HEPATOTOXICITYSee full prescribing information for complete boxed warning.∙Severe and sometimes fatal hepatotoxicity has been observed inclinical trials. (5.1)∙Monitor hepatic function prior to and during treatment. (5.1)∙Interrupt and then reduce or discontinue Stivarga for hepatotoxicity as manifested by elevated liver function tests or hepatocellularnecrosis, depending upon severity and persistence. (2.2)-------------------------- RECENT MAJOR CHANGES --------------------------Dosage and Administration (2.1) 4/2015 --------------------------- INDICATIONS AND USAGE --------------------------Stivarga is a kinase inhibitor indicated for the treatment of patients with:∙Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. (1.1)∙Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. (1.2)----------------------DOSAGE AND ADMINISTRATION ---------------------- ∙Recommended Dose: 160 mg orally, once daily for the first 21 days of each 28-day cycle. (2.1)∙Take Stivarga with a low-fat meal. (2.1, 12.3)--------------------- DOSAGE FORMS AND STRENGTHS --------------------40 mg film-coated tablets (3)------------------------------ CONTRAINDICATIONS -----------------------------None.----------------------- WARNINGS AND PRECAUTIONS ----------------------∙Hemorrhage: Permanently discontinue Stivarga for severe or life-threatening hemorrhage. (5.2) ∙Dermatological toxicity: Interrupt and then reduce or discontinue Stivarga depending on severity and persistence of dermatologic toxicity. (5.3)∙Hypertension: Temporarily or permanently discontinue Stivarga for severe or uncontrolled hypertension. (5.4)∙Cardiac ischemia and infarction: Withhold Stivarga for new or acute cardiac ischemia/infarction and resume only after resolution of acute ischemic events. (5.5)∙Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue Stivarga. (5.6)∙Gastrointestinal perforation or fistulae: Discontinue Stivarga. (5.7)∙Wound healing complications: Stop Stivarga before surgery. Discontinue in patients with wound dehiscence. (5.8)∙Embryofetal toxicity: Can cause fetal harm. Advise women of potential risk to a fetus. (5.9, 8.1)------------------------------ ADVERSE REACTIONS -----------------------------The most common adverse reactions (≥20%) are asthenia/fatigue, HFSR, diarrhea, decreased appetite/food intake, hypertension, mucositis, dysphonia, infection, pain (not otherwise specified), decreased weight, gastrointestinal and abdominal pain, rash, fever, and nausea. (6)To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800FDA-1088 or /medwatch------------------------------ DRUG INTERACTIONS -----------------------------∙Strong CYP3A4 inducers: Avoid strong CYP3A4 inducers. (7.1)∙Strong CYP3A4 inhibitors: Avoid strong CYP3A4 inhibitors. (7.2)----------------------- USE IN SPECIFIC POPULATIONS ----------------------Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of the drug to the mother. (8.3)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 4/2015FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: HEPATOTOXICITY1 INDICATIONS AND USAGE1.1 Colorectal Cancer1.2 Gastrointestinal Stromal Tumors2 DOSAGE AND ADMINISTRATION2.1 Recommended Dose2.2 Dose Modifications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Hepatotoxicity5.2 Hemorrhage5.3 Dermatological Toxicity5.4 Hypertension5.5 Cardiac Ischemia and Infarction5.6 Reversible Posterior Leukoencephalopathy Syndrome (RPLS)5.7 Gastrointestinal Perforation or Fistula5.8 Wound Healing Complications5.9 Embryo-Fetal Toxicity6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Effect of Strong CYP3A4 Inducers on Regorafenib7.2 Effect of Strong CYP3A4 Inhibitors on Regorafenib8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment8.8 Females and Males of Reproductive Potential10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.3 Pharmacokinetics12.6 Cardiac Electrophysiology13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Colorectal Cancer14.2 Gastrointestinal Stromal Tumors16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage and Handling17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.FULL PRESCRIBING INFORMATIONWARNING: HEPATOTOXICITY∙Severe and sometimes fatal hepatotoxicity has been observed in clinical trials [see Warnings and Precautions(5.1)].∙ Monitor hepatic function prior to and during treatment [see Warnings and Precautions (5.1)].∙ Interrupt and then reduce or discontinue Stivarga for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence [see Dosage and Administration (2.2)].1 INDICATIONS AND USAGE1.1 Colorectal CancerStivarga® is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.1.2 Gastrointestinal Stromal TumorsStivarga is indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.2 DOSAGE AND ADMINISTRATION2.1 Recommended DoseThe recommended dose is 160 mg regorafenib (four 40 mg tablets) taken orally once daily for the first 21 days of each 28day cycle. Continue treatment until disease progression or unacceptable toxicity.Take Stivarga at the same time each day. Swallow tablet whole with water after a low-fat meal that contains less than 600 calories and less than 30% fat [see Clinical Pharmacology (12.3)]. Do not take two doses of Stivarga on the same day to make up for a missed dose from the previous day.2.2 Dose ModificationsInterrupt Stivarga for the following:∙ NCI CTCAE Grade 2 hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia (PPE)] that is recurrent or does not improve within 7 days despite dose reduction; interrupt therapy for a minimum of 7 days for Grade 3 HFSR ∙ Symptomatic Grade 2 hypertension∙ Any NCI CTCAE Grade 3 or 4 adverse reactionReduce the dose of Stivarga to 120 mg:∙ For the first occurrence of Grade 2 HFSR of any duration∙ After recovery of any Grade 3 or 4 adverse reaction∙ For Grade 3 aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevation; only resume if the potential benefit outweighs the risk of hepatotoxicityReduce the dose of Stivarga to 80 mg:∙For re-occurrence of Grade 2 HFSR at the 120 mg dose∙After recovery of any Grade 3 or 4 adverse reaction at the 120 mg dose (except hepatotoxicity)Discontinue Stivarga permanently for the following:∙Failure to tolerate 80 mg dose∙Any occurrence of AST or ALT more than 20 times the upper limit of normal (ULN)∙Any occurrence of AST or ALT more than 3 times ULN with concurrent bilirubin more than 2 times ULN∙Re-occurrence of AST or ALT more than 5 times ULN despite dose reduction to 120 mg∙For any Grade 4 adverse reaction; only resume if the potential benefit outweighs the risks3 DOSAGE FORMS AND STRENGTHSStivarga is a 40 mg, light pink, oval shaped, film-coated tablet, debossed with ‘BAYER’ on one side and ‘40’ on the other side.4 CONTRAINDICATIONSNone5 WARNINGS AND PRECAUTIONS5.1 HepatotoxicitySevere drug induced liver injury with fatal outcome occurred in 0.3% of 1200 Stivarga-treated patients across all clinical trials. Liver biopsy results, when available, showed hepatocyte necrosis with lymphocyte infiltration. In Study 1, fatal hepatic failure occurred in 1.6% of patients in the regorafenib arm and in 0.4% of patients in the placebo arm; all the patients with hepatic failure had metastatic disease in the liver. In Study 2, fatal hepatic failure occurred in 0.8% of patients in the regorafenib arm [see Adverse Reactions (6.1)].Obtain liver function tests (ALT, AST and bilirubin) before initiation of Stivarga and monitor at least every two weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the ULN or baseline.Temporarily hold and then reduce or permanently discontinue Stivarga depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis [see Dosage and Administration (2.2)].5.2 HemorrhageStivarga caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 21% and 11% in Stivargatreated patients compared to 8% and 3% in placebo-treated patients in Studies 1 and 2. Fatal hemorrhage occurred in 4 of 632 (0.6%) of Stivarga-treated patients in Studies 1 and 2 and involved the respiratory, gastrointestinal, or genitourinary tracts.Permanently discontinue Stivarga in patients with severe or life-threatening hemorrhage. Monitor INR levels more frequently in patients receiving warfarin [see Clinical Pharmacology (12.3)].5.3 Dermatological ToxicityStivarga caused increased incidences of adverse reactions involving the skin and subcutaneous tissues (72% versus 24% in Study 1 and 78% versus 24% in Study 2), including hand-foot skin reaction (HFSR) also known as palmar-plantar erythrodysesthesia (PPE), and severe rash requiring dose modification.The overall incidence of HFSR was higher in Stivarga-treated patients, (45% versus 7% in Study 1 and 67% versus 12% in Study 2), than in the placebo-treated patients. Most cases of HFSR in Stivarga-treated patients appeared during the first cycle of treatment (69% and 71% of patients who developed HFSR in Study 1 and Study 2, respectively). The incidence of Grade 3 HFSR (17% versus 0% in Study 1 and 22% versus 0% in Study 2), Grade 3 rash (6% versus <1% in Study 1 and 7% versus 0% in Study 2), serious adverse reactions of erythema multiforme (0.2% vs. 0% in Study 1) and Stevens Johnson Syndrome (0.2% vs. 0% in Study 1) was higher in Stivarga-treated patients [see Adverse Reactions (6.1)].Toxic epidermal necrolysis occurred in 0.17% of 1200 Stivarga-treated patients across all clinical trials.Withhold Stivarga, reduce the dose, or permanently discontinue Stivarga depending on the severity and persistence of dermatologic toxicity [see Dosage and Administration (2.2)]. Institute supportive measures for symptomatic relief.5.4 HypertensionStivarga caused an increased incidence of hypertension (30% versus 8% in Study 1 and 59% versus 27% in Study 2) [see Adverse Reactions (6.1)]. Hypertensive crisis occurred in 0.25% of 1200 Stivarga-treated patients across all clinical trials. The onset of hypertension occurred during the first cycle of treatment in most patients who developed hypertension (72% in Study 1 and Study 2).Do not initiate Stivarga unless blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold Stivarga for severe or uncontrolled hypertension [see Dosage and Administration (2.2)].5.5 Cardiac Ischemia and InfarctionStivarga increased the incidence of myocardial ischemia and infarction in Study 1 (1.2% versus 0.4%) [see Adverse Reactions (6.1)]. Withhold Stivarga in patients who develop new or acute onset cardiac ischemia or infarction. Resume Stivarga only after resolution of acute cardiac ischemic events, if the potential benefits outweigh the risks of further cardiac ischemia.5.6 Reversible Posterior Leukoencephalopathy Syndrome (RPLS)Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in one of 1200 Stivarga-treated patients across all clinical trials. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue Stivarga in patients who develop RPLS.5.7 Gastrointestinal Perforation or FistulaGastrointestinal perforation or fistula occurred in 0.6% of 1200 patients treated with Stivarga across all clinical trials; this included four fatal events. In Study 2, 2.1% (4/188) of Stivarga-treated patients who were treated during the blinded or open-label portion of the study developed gastrointestinal fistula or perforation; of these, two cases of gastrointestinal perforation were fatal. Permanently discontinue Stivarga in patients who develop gastrointestinal perforation or fistula.5.8 Wound Healing ComplicationsNo formal studies of the effect of regorafenib on wound healing have been conducted. Since vascular endothelial growth factor receptor (VEGFR) inhibitors such as regorafenib can impair wound healing, treatment with regorafenib should be stopped at least 2 weeks prior to scheduled surgery. The decision to resume regorafenib after surgery should be based on clinical judgment of adequate wound healing. Regorafenib should be discontinued in patients with wound dehiscence. 5.9 Embryo-Fetal ToxicityStivarga can cause fetal harm when administered to a pregnant woman. Regorafenib was embryolethal and teratogenic in rats and rabbits at exposures lower than human exposures at the recommended dose, with increased incidences of cardiovascular, genitourinary, and skeletal malformations. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)].6 ADVERSE REACTIONSThe following serious adverse reactions are discussed elsewhere in the labeling:∙Hepatotoxicity [See Warnings and Precautions (5.1)]∙Hemorrhage [See Warnings and Precautions (5.2)]∙Dermatological Toxicity [See Warnings and Precautions (5.3)]∙Hypertension [See Warnings and Precautions (5.4)]∙Cardiac Ischemia and Infarction [See Warnings and Precautions (5.5)]∙Reversible Posterior Leukoencephalopathy Syndrome (RPLS) [See Warnings and Precautions (5.6)]∙Gastrointestinal Perforation or Fistula [See Warnings and Precautions (5.7)]Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rate observed in practice.The most frequently observed adverse drug reactions (≥20%) in patients receiving Stivarga are asthenia/fatigue, HFSR, diarrhea, decreased appetite/food intake, hypertension, mucositis, dysphonia, infection, pain (not otherwise specified), decreased weight, gastrointestinal and abdominal pain, rash, fever, and nausea.The most serious adverse drug reactions in patients receiving Stivarga are hepatotoxicity, hemorrhage, and gastrointestinal perforation.6.1 Clinical Trials ExperienceColorectal CancerThe safety data described below, except where noted, are derived from a randomized (2:1), double-blind, placebo-controlled trial (Study 1) in which 500 patients (median age 61 years; 61% men) with previously-treated metastatic colorectal cancer received Stivarga as a single agent at the dose of 160 mg daily for the first 3 weeks of each 4 week treatment cycle and 253 patients (median age 61 years; 60% men) received placebo. The median duration of therapy was 7.3 (range 0.3, 47.0) weeks for patients receiving Stivarga. Due to adverse reactions, 61% of the patients receiving Stivarga required a dose interruption and 38% of the patients had their dose reduced. Drug-related adverse reactions that resulted in treatment discontinuation were reported in 8.2% of Stivarga-treated patients compared to 1.2% of patients whoreceived placebo. Hand-foot skin reaction (HFSR) and rash were the most common reasons for permanent discontinuation of Stivarga.Table 1 compares the incidence of adverse reactions (≥10%) in patients receiving Stivarga and reported more commonly than in patients receiving placebo (Study 1).Table 1 Adverse drug reactions (≥10%) reported in patients treated with Stivarga in Study 1 and reported more commonly than in patients receiving placeboAdverse ReactionsStivarga(N=500)Placebo(N=253) Grade GradeAll%≥ 3%All%≥ 3%General disorders and administration site conditionsAsthenia/fatigue PainFever 642928153246211592Metabolism and nutrition disordersDecreased appetite and food intake 47 5 28 4Skin and subcutaneous tissue disorders HFSR/PPERash a 452617674<1Gastrointestinal disorders DiarrheaMucositis 4333841752InvestigationsWeight loss 32 <1 10 0 Infections and infestationsInfection 31 9 17 6 Vascular disordersHypertension Hemorrhage b 30218288<1<1Respiratory, thoracic and mediastinaldisordersDysphonia 30 0 6 0Nervous system disordersHeadache 10<170 amaculo-papular rash, papular rash, and pruritic rash.b Fatal outcomes observed.Laboratory AbnormalitiesLaboratory abnormalities observed in Study 1 are shown in Table 2. Table 2 Laboratory test abnormalities reported in Study 1 Laboratory Parameter Stivarga (N=500 a) Placebo(N=253 a )Grade b Grade b All %3 %4 %All %3 %4 %Blood and lymphatic systemdisordersAnemia 79 5 1 66 3 0Thrombocytopenia 41 2 <1 17 <1 0 Neutropenia 3 1 0 0 0 0 Lymphopenia 54 9 0 34 3 0 Metabolism and nutrition disorders Hypocalcemia 59 1 <1 18 1 0 Hypokalemia 26 4 0 8 <1 0 Hyponatremia30 7 1 22 4 0 Hypophosphatemia 57 31 1 11 4 0 Hepatobiliary disordersHyperbilirubinemia 45 10 3 17 5 3 Increased AST 65 5 1 46 4 1 Increased ALT 45 5 1 30 3 <1 Renal and urinary disordersProteinuria 60 <1 0 34 <1 0 InvestigationsIncreased INR c24 4 N/A 17 2 N/AIncreased Lipase 46 9 2 19 3 2Increased Amylase 26 2 <1 17 2 <1 a% based on number of patients with post-baseline samples which may be less than 500 (regorafenib) or 253 (placebo). bCommon Terminology Criteria for Adverse Events (CTCAE), v3.0. cInternational normalized ratio: No Grade 4 denoted in CTCAE, v3.0. Gastrointestinal Stromal TumorsThe safety data described below are derived from a randomized (2:1), double-blind, placebo-controlled trial (Study 2) in which 132 patients (median age 60 years; 64% men) with previously-treated GIST received Stivarga as a single agent at a dose of 160 mg daily for the first 3 weeks of each 4 week treatment cycle and 66 patients (median age 61 years; 64% men) received placebo. The median duration of therapy was 22.9 (range 0.1, 50.9) weeks for patients receiving Stivarga. Dose interruptions for adverse events were required in 58% of patients receiving Stivarga and 50% of patients had their dose reduced. Drug-related adverse reactions that resulted in treatment discontinuation were reported in 2.3% of Stivargatreated patients compared to 1.5% of patients who received placebo.Table 3 compares the incidence of adverse reactions (≥10%) in GIST patients receiving Stivarga and reported more commonly than in patients receiving placebo (Study 2).Table 3 Adverse reactions (≥10%) reported in patients treated with Stivarga in Study 2 and reported more commonly than in patients receiving placeboAdverse ReactionsStivarga(N=132)Placebo(N=66)Grade Grade All%≥ 3%All%≥ 3%Skin and subcutaneous tissue disordersHFSR/PPE Rash a Alopecia 673024227212322General disorders and administration site conditionsAsthenia/Fatigue Fever 52214391122Vascular disordersHypertension Hemorrhage 59112842735Gastrointestinal disordersDiarrhea Mucositis Nausea Vomiting 47402017822<19812822Respiratory, thoracic and mediastinaldisordersDysphonia 3990 Infections and infestationsInfection 32550 Metabolism and nutrition disordersDecreased appetite and food intake Hypothyroidism b 3118<12163Nervous system disordersHeadache 1690 InvestigationsWeight loss 14 0 8 0Musculoskeletal and connective tissuedisordersMusculoskeletal stiffness 14 0 3 0a The term rash represents reports of events of rash, erythematous rash, macular rash, maculo-papular rash, papular rashand pruritic rash.b Hypothyroidism incidence based on subset of patients with normal TSH and no thyroid supplementation at baseline.Laboratory AbnormalitiesLaboratory abnormalities observed in Study 2 are shown in Table 4. Table 4 Laboratory test abnormalities reported in Study 2Laboratory ParameterStivarga(N=132 a)Placebo(N=66 a)Grade b Grade bAll%3%4%All%3%4%Blood and lymphaticsystem disordersThrombocytopenia 13 1 0 2 0 2 Neutropenia 16 2 0 12 3 0 Lymphopenia 30 8 0 24 3 0 Metabolism and nutritiondisordersHypocalcemia 17 2 0 5 0 0 Hypokalemia 21 3 0 3 0 0 Hypophosphatemia 55 20 2 3 2 0 Hepatobiliary disordersHyperbilirubinemia 33 3 1 12 2 0Increased AST 58 3 1 47 3 0Increased ALT 39 4 1 39 2 0Renal and urinarydisordersProteinuria 333-c 30 3 -c InvestigationsIncreasedLipase 14 0 1 5 0 0ab CTCAE, v4.0.c No Grade 4 denoted in CTCAE, v4.0.6.2 Postmarketing ExperienceThe following adverse reaction has been identified during postapproval use of Stivarga. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:hypersensitivity reaction7 DRUG INTERACTIONS7.1 Effect of Strong CYP3A4 Inducers on RegorafenibCo-administration of a strong CYP3A4 inducer (rifampin) with a single 160 mg dose of Stivarga decreased the mean exposure of regorafenib, increased the mean exposure of the active metabolite M-5, and resulted in no change in the mean exposure of the active metabolite M-2. Avoid concomitant use of Stivarga with strong CYP3A4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John’s Wort) [see Clinical Pharmacology (12.3)].7.2 Effect of Strong CYP3A4 Inhibitors on RegorafenibCo-administration of a strong CYP3A4 inhibitor (ketoconazole) with a single 160 mg dose of Stivarga increased the mean exposure of regorafenib and decreased the mean exposure of the active metabolites M-2 and M-5. Avoid concomitant use of Stivarga with strong inhibitors of CYP3A4 activity (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, and voriconazole) [see Clinical Pharmacology (12.3)].8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category D [see Warnings and Precautions (5.9)]Risk SummaryBased on its mechanism of action, Stivarga can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies with Stivarga in pregnant women. Regorafenib was embryolethal and teratogenic in rats and rabbits at exposures lower than human exposures at the recommended dose, with increased incidences of cardiovascular, genitourinary, and skeletal malformations. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.Animal DataIn embryo-fetal development studies, a total loss of pregnancy (100% resorption of litter) was observed in rats at doses as low as 1 mg/kg (approximately 6% of the recommended human dose, based on body surface area) and in rabbits at doses as low as 1.6 mg/kg (approximately 25% of the human exposure at the clinically recommended dose measured by AUC).In a single dose distribution study in pregnant rats, there was increased penetration of regorafenib across the blood-brain barrier in fetuses compared to dams. In a repeat dose study with daily administration of regorafenib to pregnant rats during organogenesis, findings included delayed ossification in fetuses at doses > 0.8 mg/kg (approximately 5% of the recommended human dose based on body surface area) with dose-dependent increases in skeletal malformations including cleft palate and enlarged fontanelle at doses ≥ 1 mg/kg (approximately 10% of the clinical exposure based on AUC). At doses ≥ 1.6 mg/kg (approximately 11% of the recommended human dose based on body surface area), there were dose-dependent increases in the incidence of cardiovascular malformations, external abnormalities, diaphragmatic hernia, and dilation of the renal pelvis.In pregnant rabbits administered regorafenib daily during organogenesis, there were findings of ventricular septal defects evident at the lowest tested dose of 0.4 mg/kg (approximately 7% of the AUC in patients at the recommended dose). At doses of ≥ 0.8 mg/kg (approximately 15% of the human exposure at the recommended human dose based on AUC), administration of regorafenib resulted in dose-dependent increases in the incidence of additional cardiovascular malformations and skeletal anomalies as well as significant adverse effects on the urinary system including missing kidney/ureter; small, deformed and malpositioned kidney; and hydronephrosis. The proportion of viable fetuses that were male decreased with increasing dose in two rabbit embryo-fetal toxicity studies.8.3 Nursing MothersIt is unknown whether regorafenib or its metabolites are excreted in human milk. In rats, regorafenib and its metabolites are excreted in milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Stivarga, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.8.4 Pediatric UseThe safety and efficacy of Stivarga in pediatric patients less than 18 years of age have not been established.In 28-day repeat dose studies in rats there were dose-dependent findings of dentin alteration and angiectasis. These findings were observed at regorafenib doses as low as 4 mg/kg (approximately 25% of the AUC in humans at the recommended dose). In 13-week repeat dose studies in dogs there were similar findings of dentin alteration at doses as low as 20 mg/kg (approximately 43% of the AUC in humans at the recommended dose). Administration of regorafenib in these animals also led to persistent growth and thickening of the femoral epiphyseal growth plate.8.5 Geriatric UseOf the 632 Stivarga-treated patients enrolled in Studies 1 and 2, 37% were 65 years of age and over, while 8% were 75 and over. No overall differences in safety or efficacy were observed between these patients and younger patients.8.6 Hepatic ImpairmentStivarga is eliminated mainly via the hepatic route. No clinically important differences in the mean exposure of regorafenib or the active metabolites M-2 and M-5 were observed in patients with hepatocellular carcinoma and mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment compared to patients with normal hepatic function [see Clinical Pharmacology (12.3)]. No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Closely monitor patients with hepatic impairment for adverse reactions [see Warnings and Precautions (5.1)].Stivarga is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C), as it has not been studied in this population.8.7 Renal ImpairmentNo clinically relevant differences in the mean exposure of regorafenib and the active metabolites M-2 and M-5 were observed in patients with mild renal impairment (CLcr 60-89 mL/min) compared to patients with normal renal function following regorafenib 160 mg daily for 21 days [see Clinical Pharmacology (12.3)]. No dose adjustment is recommended for patients with mild renal impairment. Limited pharmacokinetic data are available from patients with moderate renal impairment (CLcr 30-59 mL/min). Stivarga has not been studied in patients with severe renal impairment or end-stage renal disease.8.8 Females and Males of Reproductive PotentialContraceptionUse effective contraception during treatment and up to 2 months after completion of therapy.InfertilityThere are no data on the effect of Stivarga on human fertility. Results from animal studies indicate that regorafenib can impair male and female fertility [see Nonclinical Toxicology (13.1)].10 OVERDOSAGEThe highest dose of Stivarga studied clinically is 220 mg per day. In the event of suspected overdose, interrupt Stivarga, institute supportive care, and observe until clinical stabilization.。
瑞戈非尼中文说明书
瑞戈非尼中文说明书瑞戈非尼中文说明书警告：肝毒性·在既往临床研究中报道有严重甚至致命的肝毒性[见警告和注意事项（5.1）]·治疗前和治疗过程中需要监测肝功能[见警告和注意事项（5.1）] ·当肝功能监测发现肝酶升高或肝细胞坏死时，应中止治疗，根据肝功能损失的严重程度和持续时间评估后续是否需要减量或停止拜万戈治疗[见剂量和用法（2.2）]1 适应症和用法1.1 结直肠癌拜万戈获批用于治疗既往接受过氟尿嘧啶、奥沙利铂和伊立替康为基础的化疗，以及既往接受过或不适合接受抗VEGF治疗、抗EGFR 治疗（RAS野生型）的转移性结直肠癌患者。
1.2 胃肠间质瘤拜万戈获批用于治疗既往接受过甲磺酸伊马替尼及苹果酸舒尼替尼治疗的局部晚期的、无法手术切除的或转移性的胃肠间质瘤患者。
1.3 肝癌拜万戈获批用于治疗既往接受过索拉非尼治疗的肝细胞肝癌。
2 用法和用量2.1 推荐剂量推荐服用拜万戈的剂量为160mg（4x40mg），口服，1日1次，28天为1个周期，每个周期的第1-21天服药。
持续治疗直至患者出现疾病进展或不可耐受的毒性反应。
在每天同一时间段服药拜万戈。
在低脂饮食（热量低于600卡路里，脂肪含量<30%）后服用[见临床药理学（12.3）]，以温开水送服。
若前1天漏服，第2天无需补服前1天的药量。
2.2 剂量调整如果需要调整剂量，每次减量40mg（1片）；推荐的拜万戈每日最低剂量为80mg。
出现以下情况时需中止拜万戈治疗：· 再次出现2度的手足皮肤反应（HFSR）[手足综合症（PPES）]或调整剂量后一周内HFSR无缓解；3度的HFSR需要停药至少7天· 有症状的2度高血压· 3-4度的任意不良反应· 任意级别的感染加重出现以下情况时拜万戈需减量至120mg：· 首次出现2度HRSF，无论时间长短· 除感染以为的其他3-4度不良反应恢复后· 3度的天冬氨酸转氨酶（AST）／丙氨酸转氨酶（ALT）升高，仅当潜在获益超过肝脏毒性的风险时才考虑继续原来的用药剂量出现以下情况时拜万戈需减量至80mg：· 在120mg剂量时，再次出现2度HFSR· 在120mg剂量时，任意3-4度不良反应恢复后（肝脏毒性或感染除外）出现以下情况时需终止拜万戈治疗：· 不能耐受80mg剂量· AST或ALT升高超过正常上限（ULN）的20倍· AST或ALT升高超过ULN的3倍且同时伴有胆红素超过ULN2倍· 在减量至120mg剂量时，再次出现AST或ALT升高超过ULN 的5倍· 任意的4度不良反应；仅当潜在获益超过风险时才考虑继续用药3 剂型和优势瑞戈非尼为40mg，淡红色，椭圆形，薄膜包衣片剂，药片两侧分别印有‘BAYER’和‘40’。
瑞戈非尼用法
瑞戈非尼用法
瑞戈非尼是一种医药产品，主要用于治疗白血病和其他一些白血病相关疾病。
它属于一类特殊的药物，称为激酶抑制剂。
瑞戈非尼通过抑制异常激酶信号通路，抑制白血病细胞的生长和增殖。
瑞戈非尼通常以口服药丸的形式给予患者。
在开始使用之前，患者应该准确地
按照医生的指示来服用药物。
一般建议在饭后服用，以减少胃部不适的发生。
每日建议剂量会根据患者的具体情况而有所不同，因此患者需要按照医生的指示来调整剂量。
在使用瑞戈非尼期间，患者需要密切关注自己的身体状况。
如果出现任何不适
或副作用，应立即告知医生。
常见的副作用包括恶心、呕吐、腹泻、疲劳等。
此外，瑞戈非尼还可能导致血小板和白细胞数量下降，增加感染和出血的风险。
因此，密切的监测和定期的血液检查是必要的。
在使用瑞戈非尼期间，患者还需要遵循一些特殊的注意事项。
首先，避免接触
任何可能引起刺激或损伤的物质，如尖锐的物体和化学品。
此外，避免食用或接触有可能被污染的食物，以免引发食物中毒。
最后，遵循良好的个人卫生习惯，保持清洁和卫生。
总之，瑞戈非尼是一种用于治疗白血病和其他白血病相关疾病的药物。
患者在
使用瑞戈非尼期间应该密切遵循医生的指示，并注意监测身体状况和副作用。
此外，遵循特殊的注意事项可以帮助患者更好地管理他们的疾病。
瑞戈非尼用药购药经验
2018年癌症死亡人数可能位列第二和第四的癌症都可用瑞戈非尼进行治疗！近日，国际癌症研究机构发布了2018年的报告，报告中称：癌症是人类延长寿命最大的阻碍，全世界不幸得癌症的人数“迅速增长”，就今年2018年已经新增长1810万的病例，死亡人数已经达到960万。
其中结肠直肠癌的确诊人数预计位列第二，高达88.1万人，肝细胞癌位列第四，人数高达78.2万人。
基于罹患癌症的人数“迅速增长”这种情况，我们除了要学会预防癌症的发生之外，也要学会罹患癌症的时候如何与病魔“战斗”。
怡塔国际了解到，结肠直肠癌和肝癌的患者都可以吃瑞戈非尼进行治疗。
瑞戈非尼是一种口服的靶向药，靶向药就是进行靶向治疗的时候用的药物，靶向治疗直接瞄准癌细胞，针对这类和正常细胞不一样癌细胞来设计相应的治疗药物，服用相应治疗药物，从而达到抑制肿瘤发展的目的。
而这些相应治疗药物指的就是靶向药。
瑞戈非尼已获批治疗晚期结直肠癌和肝细胞癌（肝癌），还被批准用于胃肠间质瘤。
它在中国早已上市，中文名字叫做拜万戈。
不过一般用于治疗结直肠癌是既往接受过以氟尿嘧啶、奥沙利铂和伊立替康为基础的化疗和既往接受过或不适合接受抗VEGF治疗、抗EGFR治疗（RAS野生型）的转移性结直肠癌。
而肝癌是先吃多吉美索拉非尼，再吃瑞戈非尼的获益最大。
瑞戈非尼在国内购买一盒需要10000RMB，一个月需要买三盒，也就是一个月花费30000RMB，好消息是瑞戈非尼目前已经进入山东医保，一般买瑞戈非尼的朋友可报销40%-60%的费用，那不属于山东的患者需要瑞戈非尼怎么办呢？可以选择印度的瑞戈非尼，印度是一个仿制药大国，它有“世界药房”之称，有很多靶向药都可以在印度购买，并且药品的疗效、副作用等都与原厂的药品几乎一样，印度十多年仿制药品的技术可不是吹出来的，不少患者朋友吃的都是印度的药品，其中的原因就有：效果好，价格低。
仅怡塔国际这一家的印度瑞戈非尼的价格比国内购买瑞戈非尼医保报销60%的价格还要低一半以上。
2024常用肿瘤口服靶向药物服用注意事项与特殊情况处理
2024常用肿瘤口服靶向药物服用注意事项与特殊情况处理
现代抗肿瘤药物的一个显著特征，是出现一批针对分子异常特征的药物一一即靶向药物。
新型抗肿瘤药物分为小分子靶向药物和大分子单克隆抗体类药物，其中小分子靶向药物的服用方式通常为口服。
今天，我们简单来介绍一下这些药物的服用注意事项，以及遇到特殊情况如何处理。
01
列举一些目前常用的口服靶向药物（如下表格），针对不同病种，靶向药物种类繁多，这些药物给癌症患者带来了福音。
02
03
小分子靶向药物的服用方式通常为每日口服，长期居家服用，因此患者可能会发生漏服的情况，很多患者漏服后立即补服或者下顿加倍服用，这种做法是否正确？
另外一些吞咽困难者，有些患者可能会在服用后发生呕吐的情况，如何处理？
对于长期服用靶向药物的患者，稳定的需要浓度可以保证治疗的安全有效性，通过加倍补服来弥补漏服剂量的做法会使药物浓度明细升高，可能给患者带来严重的不良反应,甚至造成必须停药的严重后果。
另外，在服用过程中如果遇到问题，谨记2点：
遇到问题，及时咨询医生或者药师；
认真阅读药品说明书。
瑞戈非尼说明书
Stivarga瑞戈非尼片
【商品名称】Stivarga
【通用名称】瑞戈非尼片
【英文名称】regorafenib
【汉语拼音】Ruigefeinipian
【产品价格】 40mg×28片×3瓶 :30000元/盒
【适 应 症】Stivarga是一种激酶抑制剂适用于既往曾用基于氟嘧啶.奥沙利铂-和伊立替康化疗.一种抗-VEGF治疗.和.如KRAS野生型.一种抗-EGFR治疗过的转移结肠直肠癌(CRC)患者的治疗.
【用法用量】
(1)推荐剂量:160 mg口服.每天1次每28天疗程的头21天.
(2)与食物服用Stivarga(一种低脂肪早餐).
【不良反应】最常见不良反应(≥30%)是乏力/疲乏.减低食欲和食物摄入量.手足皮肤反应(HFSR) [掌足红肿(PPE)].腹泻.口腔粘膜炎.体重减轻.感染.高血压.和发音困难.
【注意事项】
(1)出血:对严重或威胁生命出血永久终止Stivarga.
(2)皮肤学毒性:瑞格非尼片价格中断和然后减低或终止Stivarga取决于皮肤学毒性的严重程度和持久性.
(3)高血压:对严重或不能控制的高血压暂时或永久终止Stivarga.
(4)心脏缺血和梗死:拒给Stivarga对新或急性心脏缺血/梗死和只有急性缺血事件解决后恢复.
(5)可逆性后部白质脑病综合征(RPLS):终止Stivarga.
(6)胃肠道穿孔或瘘管:终止Stivarga.
(7)伤口愈合并发症:瑞格非尼片哪里卖术前停止Stivarga.在伤口裂开患者中终止.
(8)胚胎胎儿毒性:可能致胎儿危害.劝告妇女对胎儿潜在风险.
【规 格】40mg.28片/盒.
【贮 藏】遮光.密封保存.
【生产企业】德国拜耳医药公司。
瑞格菲尼说明书
瑞格菲尼说明书 Document number：PBGCG-0857-BTDO-0089-PTT1998瑞格菲尼说明书商品名称:Stivarga通用名称:瑞戈非尼片英文名称:regorafenib汉语拼音:Ruigefeinipian【产品价格】40mg×28片×3瓶【适应症】Stivarga是一种激酶抑制剂适用于既往曾用基于氟嘧啶，奥沙利铂-和伊立替康化疗，一种抗-VEGF治疗，和，如KRAS野生型，一种抗-EGFR治疗过的转移结肠直肠癌(CRC)患者的治疗。
【用法用量】（1）推荐剂量：160mg口服，每天1次每28天疗程的头21天。
（2）与食物服用Stivarga(一种低脂肪早餐)。
【不良反应】最常见不良反应(≥30%)是乏力/疲乏，减低食欲和食物摄入量，手足皮肤反应(HFSR)[掌足红肿(PPE)]，腹泻，口腔粘膜炎，体重减轻，感染，高血压，和发音困难。
【注意事项】（1）出血：对严重或威胁生命出血永久终止Stivarga。
（2）皮肤学毒性：瑞格非尼片价格中断和然后减低或终止Stivarga取决于皮肤学毒性的严重程度和持久性。
（3）高血压：对严重或不能控制的高血压暂时或永久终止Stivarga（4）心脏缺血和梗死：拒给Stivarga对新或急性心脏缺血/梗死和只有急性缺血事件解决后恢复。
（5）可逆性后部白质脑病综合征(RPLS)：终止Stivarga。
（6）胃肠道穿孔或瘘管：终止Stivarga。
（7）伤口愈合并发症：瑞格非尼片哪里卖术前停止Stivarga。
在伤口裂开患者中终止。
（8）胚胎胎儿毒性：可能致胎儿危害。
劝告妇女对胎儿潜在风险。
【规格】40mg，28片/盒。
【贮藏】遮光，密封保存。
【生产企业】德国拜耳医药公司。
瑞戈非尼片
瑞戈非尼片
(Stivarga)
说明书与价格
商品名称
: Stivarga
通用名称
:
瑞戈非尼片
英文名称
: regorafenib
汉语拼音
: Ruigefeinipian
[适应症]Stivarga是一种激酶抑制剂适用于既往曾用基于氟嘧啶.奥沙利铂-和伊立替康化疗.一种抗-VEGF治疗.和.如KRAS野生型.一种抗-EGFR治疗过的转移结肠直肠癌(CRC)患者的治疗.
[用法用量](1)推荐剂量:160 mg口服.每天1次每28天疗程的头21天.
(2)与食物服用Stivarga(一种低脂肪早餐).
[不良反应]最常见不良反应(≥30%)是乏力/疲乏.减低食欲和食物摄入量.手足皮肤反应(HFSR) [掌足红肿(PPE)].腹泻.口腔粘膜炎.体重减轻.感染.高血压.和发音困难.
[注意事项]
(1)出血:对严重或威胁生命出血永久终止Stivarga.
(2)皮肤学毒性:瑞格非尼片价格中断和然后减低或终止Stivarga取决于皮肤学毒性的严重程度和持久性.
(3)高血压:对严重或不能控制的高血压暂时或永久终止Stivarga.
(4)心脏缺血和梗死:拒给Stivarga对新或急性心脏缺血/梗死和只有急性缺血事件解决后恢复.
(5)可逆性后部白质脑病综合征(RPLS):终止Stivarga.
(6)胃肠道穿孔或瘘管:终止Stivarga.
(7)伤口愈合并发症:瑞格非尼片哪里卖术前停止Stivarga.在伤口裂开患者中终止.
(8)胚胎胎儿毒性:可能致胎儿危害.劝告妇女对胎儿潜在风险.
[规格]40mg.28片/盒.
[贮藏]遮光.密封保存.
[生产企业]德国拜耳医药公司。
服用靶向药瑞戈非尼几天看到效果？怎么服药？
服用靶向药瑞戈非尼几天看到效果？怎么服药？瑞戈非尼（瑞格非尼）是一种多靶点分子靶向药物，不仅可以抑制肿瘤细胞的生长和转移，还可以阻断供应肿瘤组织的新生血管，通过这些途径控制肿瘤。
瑞戈非尼通过将信号从细胞表面传输到细胞内部来发挥作用。
瑞戈非尼可以阻断几种酶蛋白。
那么，今天让我们详细了解一下研究结果显示，瑞戈非尼组的中位总生存期为 10.6 个月，对照组的中位生存期为 7.8 个月（HR = 0.62，P <0.001），瑞戈非尼的中位无进展生存期为。
该组的值为10.6 个月。
它也更长（3.1 个月对1.5 个月，HR = 0.46，P <0.001）并且疾病进展的时间更长（3.2 个月对1.5 个月，HR = 0.44，P <0.001）。
)，疾病控制率也较高（65.2% vs 36.1%，P <0.001），完全和部分缓解率较高（10.6% vs 4.1%，P = 0.01）。
一般来说，服用瑞戈非尼一个月左右，患者可以明显感觉到自己的症状有所缓解。
患者对药物的敏感性与患者自身的身体状况有关，药物作用的持续时间因人而异。
是的，瑞戈非尼对患者的作用持续时间各不相同。
建议您在服用此药后1个月内去医院就诊。
患者不应急躁。
一般来说，靶向药物的开始时间比其他治疗要长一点。
推荐剂量：推荐剂量为 160 毫克（4 片，每片 40 毫克），每天一次，在每个疗程的前 21 天口服。
每 28 天处理一次。
如何服用：瑞戈非尼应在每天低脂早餐（30% 脂肪含量）后的同一时间吞服。
不要在同一天服用两次以弥补错过的剂量（前一天）。
如果服用瑞戈非尼后出现呕吐，患者不应在同一天再次服用。
剂量调整和使用特别说明：基于个人安全性和耐受性考虑，您可能需要停止或减肥。
每次应使用 40 mg（1 片）的剂量调整。
推荐的最小日剂量为 80 毫克，最大日剂量为 160 毫克。
最常见的副作用（≥3）0%）是虚弱/不适、食欲不振、食欲不振、肢体皮肤反应（HFSR）手掌红斑（PPE）、腹泻、口腔粘膜炎、身体体重减轻、感染、高血压、呼吸困难。
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瑞戈非尼合理用药要点
通用名:瑞戈非尼片
制剂与规格:片剂:40mg
适应证:
1.既往接受过甲苯磺酸索拉非尼治疗的肝细胞癌（HCC）患者。
2.既往接受过甲磺酸伊马替尼及苹果酸舒尼替尼治疗的局部晚期的、无法手术切除的或转移性胃肠道间质瘤患者。
3.既往接受过氟尿嘧啶、奥沙利铂和伊立替康为基础的化疗，以及既往接受过或不适合接受抗VEGF治疗、抗EGFR治疗（RAS野生型）的转移性结直肠癌（CRC）患者。
合理用药要点:
1.用药前无需进行基因检测。
2.药品说明书推荐剂量为160mg口服，每日一次用药3周停药1周。
基于个人的安全及耐受性考虑，可能需要中断或降低剂量，也可以考虑采用80~120mg起始剂量逐渐递增。
3.亚洲人群最常见不良反应为手足皮肤反应、肝功能异常（高胆红素血症、ALT升高、AST升高）和高血压，同时还要注意疼痛、乏力、腹泻、食欲下降及进食减少等不良反应；最严重的不良反应为重度肝损伤、出血及胃肠道穿孔及感染；有血栓、栓塞病史者应审慎使用。
4.对瑞戈非尼任一活性物质或辅料有超敏反应的患者禁用。
5.与CYP3A4活性的强抑制剂（如克拉霉素、葡萄柚汁、伊曲康唑、酮康唑、泊沙康唑、泰利霉素和伏立康唑），强UGT1A9抑制剂（如甲灭酸、二氟尼柳和尼氟酸），强CYP3A4诱导剂（利福平、苯妥英、卡马西平、苯巴比妥和贯叶连翘），需尽量避免同时使用。