Odomzo（sonidegib）是由诺华制药开发，是一种每日一次的口服胶囊，用于治疗手术或放疗后复发，以及不适用手术或放疗的局部晚期基底细胞癌患者 近日,美国食品和药品监督管理局(FDA)批准Odomzo(sonidegib)治疗有局部晚期基底细胞癌患者手术或放疗后复发，或不是对手术或放疗被选者。 皮肤癌是较常见癌而基底细胞癌约占非-黑色素瘤皮肤癌的80%。基底细胞癌开始在皮肤的顶层(被称为表皮)和通常发生在曾被经常暴露在阳光下和紫外辐射的其他形式的区域。按照美国国家癌症研究所，非-黑色素瘤皮肤癌的新病例数似乎每年增加。局部地晚期基底细胞皮肤癌指基底癌尚未播散至机体其他部位，但不能用局部治疗根治，特别是手术和辐射。 Odomzo是一种药丸每天服用1次。它通过抑制一种分子途径作用，被称为刺猬信号通路[Hedgehog pathway]，在基底细胞癌中活化。通过抑制这个通路，Odomzo可能停止或减低癌性病变的生长。 FDA的药品评价和研究中心血液学和肿瘤室主任Richard Pazdur，M.D.说：“我们对涉及癌症分子途径了解的增加导致在难以治疗疾病中许多肿瘤药物的批准其中少数治疗选择以前存在，” “感谢对刺猬信号通路的更好了解，只是在过去三年，FDA现已两个药物为基底细胞癌的治疗。”在2012年，Erivedge(维莫德吉[vismodegib]是被批准治疗局部晚期和转移基底细胞癌前列个药物。 批准日期：2015年7月24日[诺华] 2017年11月28日[太阳药业]   公司：诺华制药，太阳药业 ODOMZO（索尼德吉 sonidegib）胶囊，口服使用 美国最初批准：2015年 警告： 胚胎-胎儿毒性见完全警告的完整预定信息。 当给予孕妇时，ODOMZO可导致胚胎 - 胎儿死亡或严重的出生缺陷，并且在动物中具有胚胎毒性，胎儿毒性和致畸性。 在开始治疗之前验证具有生殖潜力的女性的怀孕状态。建议具有生殖潜力的雌性在ODOMZO治疗期间使用有效避孕药，并在最后一次给药后至少20个月。 建议男性有可能通过精液接触风险，并在使用ODOMZO治疗期间与怀孕伴侣或具有生殖潜力的女性伴侣使用避孕套，并在最后一次给药后至少8个月。 作用机制 Sonidegib是Hedgehog途径的抑制剂。Sonidegib结合并抑制Smoothened，一种参与Hedgehog信号转导的跨膜蛋白。 适应症和用法 ODOMZO是一种hedgehog通路抑制剂，适用于治疗患有局部晚期基底细胞癌（BCC）的成人患者，这些患者在手术或放射治疗后复发，或者不适合手术或放射治疗的患者。 剂量和给药 推荐剂量：每天口服200毫克，空腹服用，至少1小时或饭后2小时服用。 剂量形式和强度 200毫克胶囊（相当于281毫克的sonidegib二磷酸盐） 禁忌症 没有。 警告和注意事项 献血：建议患者在使用ODOMZO治疗期间不要捐献血液或血液制品，并在最后一次给药后至少20个月。 肌肉骨骼不良反应：在开始治疗之前，在治疗期间定期获得血清肌酸激酶（CK）和肌酸酐水平，并且如临床指示。根据肌肉骨骼不良反应的严重程度，可能需要暂停剂量中断或停止使用ODOMZO。 不良反应 在≥10％的患者中发生的最常见的不良反应是肌肉痉挛，脱发，味觉障碍，疲劳，恶心，肌肉骨骼疼痛，腹泻，体重减轻，食欲减退，肌痛，腹痛，头痛，疼痛，呕吐和瘙痒。 要报告疑似不良反应，请致电1-800-406-7984联系Sun Pharmaceutical Industries，Inc。或致电1-800-FDA-1088或WWW.FDA.GOV/MEDWATCH联系FDA。 药物相互作用 CYP3A抑制剂：避免使用强效CYP3A抑制剂。避免长期（超过14天）使用中度CYP3A抑制剂。 CYP3A诱导剂：避免使用强效和中度CYP3A诱导剂。 用于特定人群 哺乳期：在ODOMZO治疗期间和最后一次给药后至少20个月内不要母乳喂养。 包装提供/存储和处理 每个ODOMZO胶囊都有一个不透明的粉红色，胶囊体上印有“SONIDEGIB 200MG”，黑色墨水上印有“NVR”。 ODOMZO胶囊供货如下： 一瓶30粒NDC 47335-303-83 储存在25°C（77°F）; 允许偏移15°C至30°C（59°F至86°F）[见USP受控室温]。 完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=028312dc-d155-4fd5-8abd-6bb9f011d3cc Odomzo(Sonidegib Capsules) ODOMZO(sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. IMPORTANT SAFETY INFORMATION WARNING: EMBRYO-FETAL TOXICITY ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals Verify the pregnancy status of females of reproductive potential prior to initiating therapy. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with ODOMZO and for at least 8 months after the last dose Embryo-fetal Toxicity: ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Females of Reproductive Potential: Verify pregnancy status prior to initiating ODOMZO. Advise females to use effective contraception and not to breastfeed, due to the potential for serious adverse reactions in breastfed infants, during treatment and for at least 20 months after the last dose. Based on animal studies, female fertility may be compromised. Report pregnancies to Sun Pharmaceutical Industries, Inc. at 1-800-406-7984. Males: Advise males to use condoms, even after a vasectomy, and to not donate semen during treatment and for at least 8 months after the last dose to avoid potential drug exposure in pregnant females or females of reproductive potential. Blood Donation: Advise patients not to donate blood or blood products while taking ODOMZO, and for at least 20 months after the last dose because their blood or blood products might be given to a female of reproductive potential. Musculoskeletal Adverse Reactions: Musculoskeletal adverse reactions, which may be accompanied by serum creatine kinase (CK) elevations, occur with ODOMZO and other drugs which inhibit the hedgehog pathway. In a pooled safety analysis of 12 clinical studies involving 571 patients with various advanced cancers treated with ODOMZO, at doses ranging from 100mg to 3000 mg, rhabdomyolysis (defined as serum CK increase of more than ten times the baseline value with a concurrent 1.5-fold or greater increase in serum creatinine above baseline value) occurred in 1 patient (0.2%) treated with ODOMZO 800 mg. In Study 1, musculoskeletal adverse reactions occurred in 68% of patients treated with ODOMZO 200 mg daily, with 9% reported as Grade 3 or 4 serum CK elevations. The most frequent musculoskeletal manifestations reported were muscle spasms (54%), musculoskeletal pain (32%), and myalgia (19%). Increased serum CK laboratory values occurred in 61% of patients, with 8% having Grade 3 or 4. Musculoskeletal pain and myalgia usually preceded serum CK elevation. ODOMZO was temporarily interrupted in 8% of patients or permanently discontinued in 8% of patients for musculoskeletal adverse reactions. The incidence of musculoskeletal adverse reactions requiring medical intervention (magnesium supplementation, muscle relaxants, analgesics or narcotics) was 29%, including four patients (5%) who received intravenous hydration or were hospitalized. Obtain baseline serum CK and creatinine levels prior to initiating ODOMZO, periodically during treatment, and as clinically indicated (eg, if muscle symptoms are reported). Obtain serum creatinine and CK levels at least weekly in patients with musculoskeletal adverse reactions with concurrent serum CK elevation greater than 2.5 times ULN until resolution of clinical signs and symptoms. Temporary dose interruption or discontinuation may be required. Advise patients starting ODOMZO of the risk of muscle-related adverse reactions and to promptly report any new unexplained muscle pain, tenderness, or weakness occurring during treatment or that persists after discontinuing ODOMZO. Drug Interactions: Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, administer for less than 14 days and monitor closely for adverse reactions, particularly musculoskeletal. Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inducers. Geriatric Use: There was a higher incidence of serious adverse events, Grade 3 and 4, and events requiring dose interruption or discontinuation in patients ≥65 years compared with younger patients; this was not attributable to an increase in any specific adverse event. Most Common Adverse Reactions: The most common adverse reactions occurring in ≥10% of patients were muscle spasms (54%), alopecia (53%), dysgeusia (46%), fatigue (41%), nausea (39%), musculoskeletal pain (32%), diarrhea (32%), decreased weight (30%), decreased appetite (23%), myalgia (19%), abdominal pain (18%), headache (15%), pain (14%), vomiting (11%), and pruritus (10%). ------------------------------------------------------- 产地国家：美国 原产地英文商品名: ODOMZO 200mg/cap 30caps/box 原产地英文药品名: sonidegib  中文参考商品译名: ODOMZO胶囊 200毫克/胶囊 30胶囊/盒 中文参考药品译名: 索尼德吉 生产厂家中文参考译名: 太阳制药 生产厂家英文名: SUN PHARMA ------------------------------------------------------- 产地国家：美国 原产地英文商品名: ODOMZO 200mg/cap 10caps/box 原产地英文药品名: sonidegib  中文参考商品译名: ODOMZO胶囊 200毫克/胶囊 10胶囊/盒 中文参考药品译名: 索尼德吉 生产厂家中文参考译名: 诺华制药 生产厂家英文名: Novartis Pharma