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  药店国别: 印度药房
产地国家: 印度
所属类别: 抗癌药物->治疗乳腺癌药物
处方药:处方药
包装规格: 125毫克/片 21片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
辉瑞制药
生产厂家英文名:
Pfizer
该药品相关信息网址1:
www.ibrance.com/info
该药品相关信息网址2:
https://en.wikipedia.org/wiki/Palbociclib
原产地英文商品名:
Palbociclib (Equivalent Ibrance) 125MG 21 caps/box
原产地英文药品名:
Palbociclib
中文参考商品译名:
帕泊昔布胶囊(等效于帕博西尼) 125毫克/片 21片/盒
中文参考药品译名:
帕泊昔布
原产地国家批准上市年份:
2015/02/03
英文适应病症1:
Advanced Breast Cancer
临床试验期:
完成
中文适应病症参考翻译1:
晚期乳腺癌
药品信息:

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 详细处方信息以本药内容附件PDF文件(201842223210534.pdf)的“原文Priscribing Information”为准
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部分中文Palbociclib(Equivalent Ibrance) 处方资料(仅供参考)

    FDA于2013年4月授予palbociclib治疗晚期或转移性ER+/HER2-乳腺癌的突破性疗法认定。目前IBRANCE可以与来曲唑联合应用作为治疗ER阳性/HER2阴性绝经后 - 不转移性乳腺癌的一线治疗 。这个适应 是根据无进展生存(PFS)在加速批准下被批准。   辉瑞 Ibrance 的一项 3 期试验显示,接受 Ibrance 与阿斯利康氟维司群(Faslodex)合并用药治疗的患者在疾病恶化之前平均存活了 9.2 个月,氟维司群是一款普遍应用的阻断雌激素的治疗药物。相比之下,以氟维司群加安慰剂治疗的患者平均存活了 3.8 个月。   2015年12月份,辉瑞公布了一项III期研究,将Ibrance用作乳腺癌二线治疗,结果显示,Ibrance疗效同样非常出色。FDA将于2016年4月作出最终审查决定。

适应证和用途
IBRANCE是一种激酶抑制剂,适用于治疗激素受体(HR)阳性,人表皮生长因子受体2(HER2)阴性晚期或转移性乳腺癌,并结合:

芳香酶抑制剂作为绝经后妇女的初始内分泌治疗; 或者

内分泌治疗后患有疾病进展的妇女的氟维司群

剂量和给药方法
IBRANCE胶囊与食物一起口服,与芳香酶抑制剂或氟维司群一起服用。(2)

推荐起始剂量:每日一次125毫克,与食物一起服用21天,然后停止服用7天。(2.1)

建议根据个人安全性和耐受性进行剂量中断和/或剂量减少。(2.2)

剂型和规格
片剂:125 mg。

禁忌证

警告和注意事项
血液系统:白细胞减少,可能会发生。监测全血细胞计数前两个周期的开始,IBRANCE疗法中,并在每个周期的开始之前,以及在第14天,并作为临床指征。
(2)感染:用于监控的症状和体征,并扣留剂量适当。
(3)胚胎胎儿毒性:可引起胎儿造成伤害。提醒潜在风险的患者胎儿,并使用有效的避孕措施。

不良反应
最常见的不良反应(发生率≥10%)为白细胞减少,白细胞减少,乏力,贫血,上呼吸道感染,恶心,口腔炎,脱发,腹泻,血小板减少症,食欲下降,呕吐,无力,周围神经病变,和鼻出血。

药物相互作用
CYP3A抑制剂:避免同时使用IBRANCE具有较强CYP3A酶抑制剂。如果不能避免的强抑制剂,降低IBRANCE剂量。
CYP3A诱导剂:避免同时使用IBRANCE具有较强的和中度CYP3A诱导剂。
CYP3A的底物:敏感CYP3A4底物具有窄治疗指数的剂量可能需要降低与IBRANCE同时给予时。

一般描述
    125mg胶囊:不透明硬明胶胶囊,大小0,有焦糖帽和体,帽上用白墨汁印,体上“PBC 125”。
    IBRANCE是一个激酶抑制剂适用与来曲唑联用为有雌激素受体(ER)-阳性,人表皮生长因子受体2(HER2)-阴性晚期乳癌绝经后妇女的治疗作为初始基于内分泌治疗对其转移疾病。这个适应证是根据无进展生存(PFS)在加速批准下被批准。剂型批准此适应证可能取决于在验证性试验中临床获益的证明和描述。
 
IBRANCE
Generic Name: Palbociclib
Company: Pfizer Inc.
Treatment for: ER-positive and HER2-negative breast cancer


Mechanism of action
It is a selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6. In the G1 phase of the cell cycle, mammalian cells must pass a checkpoint, known as the restriction point “R”, in order to complete the cell cycle and divide. CDK4 and CDK6 complex with cyclin D drive the phosphorylation of the retinoblastoma protein, Rb, which allows the cell to pass R and commit to division.Regulation of one or more proteins involved in this checkpoint is lost in many cancers. However by inhibiting CDK4/6, palbociclib ensures that the cyclin D-CDK4/6 complex cannot aid in phosphorylating Rb. This prevents the cell from passing R and exiting G1, and in turn from proceeding through the cell cycle.
Administration
Palbociclib is taken daily orally with food in a cycle of 21 days of active medication followed by 7 without. Currently palbociclib is prescribed as a combination therapy with either letrozole or fulvestrant.[5] Patients should also not consume CYP3A inhibitors or inducers while taking palbociclib. FDA information also cautions against consuming grapefruit products while taking palbociclib.
Approvals and indications
ER+ breast cancer The drug was reviewed and approved under the Food and Drug Administration’s (FDA) accelerated Priority Review and Breakthrough Therapy designation programs on February 3, 2015 as a treatment (in combination with letrozole) for patients with estrogen receptor positive advanced breast cancer.[6] This was an accelerated approval. In March 2017, the FDA granted regular approval to palbociclib for HER2 negative breast cancer, in combination with an aromatase inhibitor. A phase 3 trial, PALOMA-2, was fully enrolled by February 2015 and reported positive results in April 2016.[9] The results of PALOMA-2 trial (published November 2016) showed significantly longer progression-free survival in patients on palbociclib in combination with letrozole, compared to patients on letrozole and placebo. Progression-free survival was assessed by radiologically confirmed disease progression by RECIST criteria or death during the study. At the time of publication, there was insufficient data on overall survival, and a final analysis is planned after a total of 390 deaths occur per protocol and in agreement with regulatory agencies. Of note, it was noted that the addition of palbociclib caused higher rates of myelotoxic events in the study. The drug was approved for use in the European Union in November 2016 as a treatment for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer either in combination with an aromatase inhibitor or, for women who have received prior endocrine therapy, in combination with fulvestrant. In pre- or perimenopausal women, a luteinizing hormone releasing hormone agonist should also be given. In December 2017, palbociclib, was accepted for use by the NHS after going through the Scottish Medicines Consortium's process for medicines used to treat very rare and end-of-life breast cancer.
Adverse effects
A majority of patients taking palbociclib experiencing neutropenia, a condition where a patient has an abnormally low number of neutrophils. This side effect impacts the immune system, and is thus likely responsible for the second most common side effect, infection.[13] Leukopenia and anemia are also frequent among patients taking palbociclib.[13] More than 10% of patients also experience side effects such as fatigue, nausea, diarrhea, respiratory infection, headache, thrombocytopenia, vomiting, and decreased appetite.[14][13] The FDA also indicates that patients should be vigilant to monitor themselves for any sign of pulmonary embolism. The FDA further cautions that women should be aware that the medication can have a harmful effect on a fetus, and thus should not be taken while pregnant.
Clinical trials
HR+ breast cancer The PALOMA-3 trial announced in April 2015 that the addition of palbociclib was superior to fulvestrant alone for progression-free survival. In the phase 2 PALOMA-1 trial reported at the April 2014 annual meeting of the American Association for Cancer Research, the addition of palbociclib to letrozole was shown to significantly slow the progression of advanced cancer (median progression-free survival increased from 10.2 months to 20.2 months), but was not shown to have a statistically significant effect on increasing patients' overall survival times.
Active clinical trials
According to the NIH National Cancer Institute there are currently 39 active clinical trials testing palbociclib on its own or in combination with other medications. While a majority of these are exploring the further uses of palbociclib to treat breast cancer, other trials are investigating the potential applications of palbociclib to head and neck cancers, non-small cell lung cancer, recurring brain metastasis, squamous cell carcinoma, central nervous system tumors, and other solid tumor types. In December 2017, Pfizer announced that the PALOMA-2 trial, an ongoing phase 3 trial combining palbociclib with letrozole, showed a 44% reduction in risk of disease progression among trial subjects. The trial has also demonstrated greater than a year’s improved median progression free survival for patients on the combined therapy (as compared to letrozole on its own). PALOMA-2 median patient follow-up time now exceeds three years, making it the longest traceable data for phase 3 study of a CDK4/6 inhibitor.
Drugs with a similar mechanism of action
Palbociclib has several direct competitors currently on the market or in clinical trials. In September 2017, abemaciclib, another selective CDK4/6 inhibitor owned and manufactured by Eli Lilly, was approved for HR-positive, HER2-negative advanced metastatic breast cancer both in combination with fulvestrant and as a monotherapy. In March 2017, the FDA also approved ribociclib, owned by Novartis, as a combination therapy with aromatase inhibitors for indications similar to those of palbociclib and ribociclib. Notably, ribociclib seems to also have an inhibitory effect on Cyclin D3/CDK6 activity.[26] G1 therapeutics also has a Cdk4/6 inhibitor, trilaciclib, which is currently in phase 2 trials, but as of December 2017 has not gained FDA approval.

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 详细处方信息以本药内容附件PDF文件(201842223210534.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-4-16
附件:
201842223314929.png    

201842223210534.pdf    

 
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