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Piqray Tablets 150mg(alpelisib)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 150毫克/片 28片/盒 
包装规格 150毫克/片 28片/盒 
计价单位: 盒 
生产厂家中文参考译名:
诺华制药
生产厂家英文名:
Novartis Pharmaceuticals
该药品相关信息网址1:
https://www.drugs.com/history/piqray.html
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Piqray 150mg/tablets 28tablets/box
原产地英文药品名:
alpelisib
中文参考商品译名:
Piqray 150毫克/片 28片/盒
中文参考药品译名:
alpelisib
曾用名:
简介:

 

新型抗癌口服药Piqray(alpelisib)获FDA批准上市,为第一个也是唯一一个专门针对HR+/HER2-晚期乳腺癌PIK3CA突变患者的治疗药物
近日,美国食品和药物管理局(FDA)批准Piqray(alpelisib,以前称为BYL719)与氟维司群联合用于治疗绝经后妇女和激素受体阳性的男性,人类表皮生长因子受体-2阴性(HR+/HER2-),PIK3CA-突变,晚期或转移性乳腺癌,在基于内分泌的方案之后或之后通过FDA批准的测试检测。
Piqray是一种激活抑制剂,与氟维司群联合用于治疗绝经后妇女和男性患有HR+/HER2,PIK3CA-突变,晚期或转移性乳腺癌,在内分泌或内分泌后进行的FDA批准的检测中检测到基于治疗方案
大约40%的HR +晚期乳腺癌患者具有可能激活PI3K-α同种型的突变,称为PIK3CA突变。这些突变与内分泌治疗,疾病进展和预后不良有关。Piqray通过抑制PI3K途径(主要是PI3K-α同种型)起作用,以解决PIK3CA突变的影响。
批准日期:2019年5月24日 公司:诺华公司
PIQRAY(alpelisib)片剂,用于口服
美国最初批准:2019年
作用机制
Alpelisib是磷脂酰肌醇-3-激酶(PI3K)的抑制剂,其抑制活性主要针对PI3Kα。编码PI3K的催化α-亚基(PIK3CA)的基因中的功能获得性突变导致PI3Kα和Akt信号传导的活化,细胞转化和体外和体内模型中肿瘤的产生。
在乳腺癌细胞系中,alpelisib抑制PI3K下游靶标的磷酸化,包括Aktand在携带PIK3CA突变的细胞系中显示出活性。在体内,alpelisib抑制PI3K/Aktsignaling途径并减少异种移植模型中的肿瘤生长,包括乳腺癌模型。
已显示通过alpelisib治疗的PI3K抑制诱导乳腺癌细胞中雌激素受体(ER)转录的增加。与来自ER阳性,PIK3CA突变的乳腺癌细胞系的异种移植模型中的单独治疗相比,alpelisib和氟维司群的组合显示出增加的抗肿瘤活性。
适应症和用法
PIQRAY是一种激酶抑制剂,与氟维司群联合用于治疗绝经后妇女和男性,激素受体(HR)阳性,人表皮生长因子受体2(HER2)阴性,PIK3CA突变,晚期或转移性乳腺癌在基于内分泌的方案之后或之后通过FDA批准的测试检测。
剂量和给药
推荐剂量:每日一次口服300毫克(两片150毫克片剂)食物。
对于不良反应,请考虑剂量中断,剂量减少或停药。
剂量形式和强度
片剂:50mg,150mg,200mg
禁忌症
对PIQRAY或其任何成分严重超敏反应。
警告和注意事项
严重超敏反应:永久停止PIQRAY。及时开始适当的治疗。
严重皮肤反应:报告了严重皮肤反应的病例,包括Stevens-Johnson综合征(SJS)和红斑多形性(EM)。不要对有史密斯,EM或毒性表皮坏死松解症(TEN)病史的患者进行治疗。如果存在严重皮肤反应的症状症状,则中断PIQRAY,直至确定​​反应的病因。考虑咨询皮肤科医生。
如果确认SJS,EM或TEN,则永久停止PIQRAY。
高血糖:报告了严重的高血糖,包括酮症酸中毒。 PIQRAY在1型或非控制性2型糖尿病患者中的安全性尚未确定。在开始用PIQRAY治疗之前,测试空腹血糖(FPG),HbA1c和优化血糖。
在开始治疗后,监测期间。如临床指示,启动或优化抗高血糖药物。如果发生严重的高血糖,中断,减少剂量或停止PIQRAY。
肺炎:已报道严重的肺炎和间质性肺病。监测临床症状或放射学变化。
如果发生严重肺炎,则中断或停止PIQRAY。
腹泻:据报道,有严重的腹泻病例,包括脱水和急性肾损伤。大多数患者在使用PIQRAY治疗期间出现腹泻(≤2级)。建议患者开始抗腹泻治疗,增加口服液,并在发生腹泻时通知医务人员。如果发生切断性腹泻,则中断,减少剂量或停止PIQRAY。
胚胎 - 胎儿毒性:PIQRAY会导致胎儿伤害。告知患有胎儿潜在风险的患者并使用有效的避孕措施。
另外,请参阅氟维司群有关怀孕和避孕信息的完整处方信息。
不良反应
最常见的不良反应包括实验室异常(全部,发病率≥20%),葡萄糖增加,肌酐增加,腹泻,皮疹,淋巴细胞计数减少,GGT增加,恶心,ALT增加,疲劳,血红蛋白减少,脂肪酶增加,食欲减退,口腔炎,呕吐,体重下降,钙减少,血糖下降,aPTT延长,脱发。
要报告疑似不良反应,请致电1-888-669-6682联系NovartisPharmaceuticals Corporation,或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
药物相互作用
CYP3A4诱导剂:避免PIQRAY与强效CYP3A4诱导剂共同给药。
BCRP抑制剂:避免在接受PIQRAY治疗的患者中使用BCRP抑制剂。如果无法使用替代药物,请密切监测增加的不良反应。
CYP2C9底物:当PIQRAY与CYP2C9底物共同施用时密切监测,其中这些药物的血浆浓度降低可能降低活性。
用于特定人群
哺乳期:建议不要母乳喂养。
包装提供/存储和处理
PIQRAY(alpelisib)50mg,150mg和200 mg薄膜包衣片[见剂型和强度]。
每日300毫克剂量:每个纸箱包含2个泡罩包装。 每个泡罩包装的14天供应量为28
片剂(28片,每片150mg alpelisib)。 NDC 0078-0708-02
250毫克每日剂量:每个纸箱包含2个泡罩包装。 每个泡罩包装的14天供应量为28
片剂(14片,每片200mg alpelisib和14片,每片50mg alpelisib)。NDC 0078-0715-02
每日200毫克剂量:每个纸箱包含1个泡罩包装。 每个泡罩包装包含28天的28片药片
(每片28片,200mg alpelisib)。NDC 0078-0701-84
储存温度为20°C至25°C(68°F至77°F),允许偏差在15°C至30°C(59°F至86°F)之间[见USP受控室温]。
FDA approves Novartis Piqray-the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer
US Food and Drug Administration (FDA) has approved Piqray(alpelisib, formerly BYL719)in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen1.
PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of patients living with HR+/HER2-breast cancer have this mutation.
PIK3CA mutations are associated with tumor growth, resistance to endocrine treatment and a poor overall prognosis.
Piqray targets the effect of PIK3CA mutations and may help overcome endocrine resistance in HR+ advanced breast cancer.
About Piqray(alpelisib)
Piqray is a kinase inhibitor approved in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after endocrine-based regimen.
Approximately 40% of HR+advanced breast cancer patients have a mutation that may activate the PI3K-alpha isoform, called PIK3CA mutations. These mutations are associated with resistance to endocrine therapy, disease progression and a poor prognosis. Piqray works by inhibiting the PI3K pathway, predominantly the PI3K-alpha isoform, to address the effect of PIK3CA mutations.
About SOLAR-1
SOLAR-1 is a global, Phase III randomized, double-blind, placebo-controlled trial studying Piqray in combination with fulvestrant for postmenopausal women, and men, with PIK3CA-mutated HR+/HER2- advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor. SOLAR-1 is the pivotal Phase III trial that supported this approval.
The trial randomized 572 patients. Patients were allocated based on central tumor tissue assessment to either a PIK3CA-mutated cohort(n=341)or a PIK3CA non-mutated cohort (n=231). Within each cohort, patients were randomized in a 1:1 ratio to receive continuous oral treatment with Piqray(300mg once daily)plus fulvestrant (500 mg every 28 days+Cycle 1 Day 15)or placebo plus fulvestrant. Stratification was based on visceral metastases and prior CDK4/6 inhibitor treatment.
Patients and investigators are blinded to PIK3CA mutation status and treatment.
The primary endpoint is local investigator assessed PFS using RECIST 1.1 for patients with a PIK3CA mutation. The key secondary endpoint is overall survival, and additional secondary endpoints include, but are not limited to, overall response rate, clinical benefit rate, health-related quality of life, efficacy in PIK3CA non-mutated cohort, safety and tolerability. SOLAR-1 is ongoing to assess overall survival and other secondary endpoints.
Indication
PIQRAY(alpelisib) tablets is a prescription medicine used in combination with the medicine fulvestrant to treat women who have gone through menopause and men who have hormone receptor(HR)-positive, human epidermal growth factor receptor 2(HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body(metastatic), with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and whose disease has progressed on or after endocrine therapy. Your health care provider will test your cancer for an abnormal “PIK3CA” gene to make sure that PIQRAY is right for you. It is not known if PIQRAY is safe and effective in children.
Important Safety Information
Patients should not take PIQRAY if they have had a severe allergic reaction to PIQRAY or are allergic to any of the ingredients in PIQRAY.
PIQRAY may cause serious side effects.
PIQRAY can cause severe allergic reactions. Patients should tell their health care provider or get medical help right away if they have trouble breathing, flushing, rash, fever, or fast heart rate during treatment with PIQRAY.
PIQRAY can cause severe skin reactions. Patients should tell their health care provider or get medical help right away if they get severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, blistering of the lips, eyes or mouth, blisters on the skin or skin peeling, with or without fever.
PIQRAY can cause high blood sugar levels (hyperglycemia). Hyperglycemia is common with PIQRAY and can be severe. Health care providers will monitor patients’ blood sugar levels before they start and during treatment with PIQRAY.
Health care providers may monitor patients’ blood sugar levels more often if they have a history of Type 2 diabetes. Patients should tell their health care provider right away if they develop symptoms of hyperglycemia, including excessive thirst, dry mouth, urinate more often than usual or have a higher amount of urine than normal, or increased appetite with weight loss. PIQRAY can cause lung problems (pneumonitis).
Patients should tell their health care provider right away if they develop new or worsening symptoms of lung problems, including shortness of breath or trouble breathing, cough, or chest pain. Diarrhea is common with PIQRAY and can be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney problems. Patients who develop diarrhea during treatment with PIQRAY should tell their health care provider right away.
Before taking PIQRAY, patients should tell their health care provider if they have a history of diabetes, skin rash, redness of skin, blistering of the lips, eyes or mouth, or skin peeling, are pregnant, or plan to become pregnant as PIQRAY can harm their unborn baby.
Females who are able to become pregnant should use effective birth control during treatment with PIQRAY and for 1 week after the last dose. Do not breastfeed during treatment with PIQRAY and for 1 week after the last dose. Males with female partners who are able to become pregnant should use condoms and effective birth control during treatment with PIQRAY and for 1 week after the last dose. Patients should also read the Full Prescribing Information of fulvestrant for important pregnancy, contraception, infertility, and lactation information.
Patients should tell their health care provider all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PIQRAY and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.
The most common side effects of PIQRAY when used with fulvestrant are rash, nausea, tiredness and weakness, decreased appetite, mouth sores, vomiting, weight loss, hair loss, and changes in certain blood tests.

Attachment: Complete description:
https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/piqray.pdf 

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