Turalio胶囊 capsules 200mg(pexidartinib)

产地国家: 美国

处方药:

所属类别: 200毫克/粒 28粒/瓶

包装规格:200毫克/粒 28粒/瓶

计价单位:

生产厂家中文参考译名:第一三共公司

生产厂家英文名:Sankyo, Inc.

原产地英文商品名:Turalio 200mg/capsules 28capsules/bottle

原产地英文药品名:pexidartinib

中文参考商品译名:Turalio胶囊 200毫克/粒 28粒/瓶

中文参考药品译名:Turalio胶囊 200毫克/粒 28粒/瓶

曾用名:

简介:
近日,美国FDA批准第一三共公司开发的Turalio(pexidartinib)胶囊上市,用于治疗身体机能严重受限且无法通过手术改善病情的症状性腱鞘巨细胞瘤(TGCT)成人患者。TGCT通常都是良性肿瘤,表现为足部和手部的坚实性肿块,滑膜(关节腔表面的一层薄膜)和腱鞘增厚或过度生长而导致活动受限,可以通过手术完整切除予以治疗,恶性病变较罕见。但是有些复发的弥漫性TGCT患者,不能通过手术切除,会导致严重的关节损伤和功能丧失,严重的就需要截肢。批准日期:2019年8月2日公司:第一三共TURALIO(pexidartinib)胶囊,用于口服美国最初批准:2019年作用机制Pexidartinib是一种小分子酪氨酸激酶抑制剂,靶向集落刺激因子1受体(CSF1R),KIT原癌基因受体酪氨酸激酶(KIT),和FMS样酪氨酸激酶3(FLT3)具有内部串联重复(ITD)突变。CSF1R配体的过表达促进细胞增殖和在滑膜中积累。在体外,pexidartinib抑制依赖于CSF1R和配体诱导的CSF1R自身磷酸化的细胞的增殖。Pexidartinib还在体内抑制CSF1R依赖性细胞系的增殖。

适应症和用法

TURALIO是一种激酶抑制剂,适用于治疗患有症状性腱鞘巨细胞瘤(TGCT)的成人患者,这些患者伴有严重的发病率或功能,并且不适合手术治疗。

剂量和给药•重要的管理说明:

空腹,至少1小时或饭后2小时或零食管理TURALIO。•推荐剂量:每日口服400毫克400毫克。剂量形式和强度胶囊:200mg禁忌症没有。

警告和注意事项

•胚胎-胎儿毒性:可能导致胎儿伤害。向患有胎儿潜在风险的生殖潜力的患者提供建议并使用有效的感染方法。不良反应最常见的不良反应(>
20%)是乳酸脱氢酶增加,天冬氨酸氨基转移酶增加,头发颜色变化,疲劳,丙氨酸增加氨基转移酶,中性粒细胞减少,胆固醇增加,碱性磷酸酶增加,淋巴细胞减少,眼球水肿,血红蛋白减少,皮疹,味觉障碍,磷酸盐减少。要报告疑似不良反应

药物相互作用

•与肝毒性产品一起使用:避免将TURALIO与其他已知会导致肝毒性的产品共同给药。•强CYP3A抑制剂:如果无法避免同时使用强力CYP3A抑制剂,则减少TURALIO的剂量。•强CYP3A诱导剂:避免同时使用强CYP3A诱导剂。•UGT抑制剂:如果不能避免同时使用UGT抑制剂,则减少TURALIO的剂量。•酸减少剂:避免同时使用质子泵抑制剂。如果需要,使用组胺-2受体拮抗剂或抗酸剂。

用于特定人群

•哺乳期:建议不要母乳喂养。•肾功能损害:减轻轻度至重度肾功能损害患者的剂量。

包装提供/存储和处理

TURALIO200毫克胶囊的尺寸为0,白色不透明的身体和深绿色不透明的帽子,白色印花“T10”,可在:•28瓶NDC#:65597-402-28•120计数瓶NDC#:65597-402-20储存在20°C至25°C(68°F至77°F);允许偏移15°C至30°C(59°F至86°F)[见USP受控室温]。保持容器密闭,不要从瓶子中取出干燥剂。

Turalio胶囊英文版说明书

Approves Daiichi Sankyo’s TURALIO™ (pexidartinib) for the Treatment of Select Patients with TGCT, a Rare and Debilitating TumorU.S. Food and Drug Administration (FDA) approved TURALIO™ (pexidartinib) as the first and only treatment for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TGCT is a rare, non-malignant tumor that affects small and large joints. The disease can cause debilitating symptoms and can be locally aggressive.Indication and UsageTURALIO(pexidartinib) is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.WARNING: HEPATOTOXICITYTURALIO can cause serious and potentially fatal liver injury.Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity.TURALIO is available only through a restricted program called the TURALIO Risk eva luation and Mitigation Strategy (REMS) Program.ContraindicationsNone.Warnings and PrecautionsHepatotoxicityTURALIO can cause serious and potentially fatal liver injury and is available only through a restricted program called the TURALIO REMS. Hepatotoxicity with ductopenia and cholestasis has occurred in patients treated with TURALIO. Across 768 patients who received TURALIO in clinical trials, there were 2 irreversible cases of cholestatic liver injury. One patient with advanced cancer and ongoing liver toxicity died and one patient required a liver transplant.The mechanism of cholestatic hepatotoxicity is unknown and its occurrence cannot be predicted.It is unknown whether liver injury occurs in the absence of increased transaminases. Please see Adverse Reactions.Avoid TURALIO in patients with preexisting increased serum transaminases, total bilirubin, or direct bilirubin (>upper limit of normal [ULN]) or patients with active liver or biliary tract disease including increased alkaline phosphatase (ALP).Taking TURALIO with food increases drug exposure by 100% and may increase the risk of hepatotoxicity. Administer TURALIO on an empty stomach, either 1 hour before or 2 hours after a meal or snack. Monitor liver tests, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, ALP, and gamma-glutamyl transferase (GGT), prior to initiation of TURALIO, weekly for the first 8 weeks, every 2 weeks for the next month, and every 3 months thereafter. Withhold and dose reduce, or permanently discontinue TURALIO based on the severity of the hepatotoxicity. Rechallenging with a reduced dose of TURALIO may result in a recurrence of increased serum transaminases, bilirubin, or ALP. Monitor liver tests weekly for the first month after rechallenge.TURALIO REMSTURALIO is available only through a restricted program under a REMS, because of the risk of hepatotoxicity.Notable requirements of the TURALIO REMS Program include the following:Prescribers must be certified with the program by enrolling and completing training.Patients must complete and sign an enrollment form for inclusion in a patient registry.Pharmacies must be certified with the program and must dispense only to patients who are authorized (enrolled in the REMS patient registry) to receive TURALIO.Further information is available at turalioREMS.com or by calling 1-833-887-2546.Embryo-fetal toxicityBased on animal studies and its mechanism of action, TURALIO may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TURALIO and for 1 month after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TURALIO and for 1 week after the final dose.Adverse ReactionsThe safety of TURALIO was eva luated in ENLIVEN, in which patients received TURALIO without food at a dose of 400 mg in the morning and 600 mg in the evening orally for 2 weeks followed by 400 mg orally twice daily until disease progression or unacceptable toxicity.Serious adverse reactions (ARs) were reported in 13% of patients who received TURALIO. The most frequent serious ARs (occurring in >1 patient) included abnormal liver tests (3.3%) and hepatotoxicity (3.3%).Permanent discontinuation due to ARs occurred in 13% of patients who received TURALIO. The most frequent ARs (occurring in >1 patient) requiring permanent discontinuation included increased ALT (4.9%), increased AST (4.9%), and hepatotoxicity (3.3%).Dose reductions or interruptions occurred in 38% of patients who received TURALIO. The most frequent ARs (occurring in >1 patient) requiring a dosage reduction or interruption were increased ALT (13%), increased AST (13%), nausea (8%), increased ALP (7%), vomiting (4.9%), increased bilirubin (3.3%), increased GGT (3.3%), dizziness (3.3%), and abdominal pain (3.3%).The most common ARs (>20%) were increased lactate dehydrogenase, increased AST, hair color changes, fatigue, increased ALT, decreased neutrophils, increased cholesterol, increased ALP, decreased lymphocytes, eye edema, decreased hemoglobin, rash, dysgeusia, and decreased phosphate.Clinically relevant ARs occurring in <10% of patients were blurred vision, photophobia, diplopia, reduced visual acuity, dry mouth, stomatitis, mouth ulceration, pyrexia, cholangitis, hepatotoxicity, liver disorder, cognitive disorders (memory impairment, amnesia, confusional state, disturbance in attention, and attention deficit/hyperactivity disorder), alopecia, and skin pigment changes (hypopigmentation, depigmentation, discoloration, and hyperpigmentation).

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