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Olaparib(奥拉帕尼)国内上市时间

发布时间:2025-11-05 14:02:48 阅读:1007 来源:问药网
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奥拉帕利

奥拉帕利 生产厂家:东盟(老挝)制药与食品有限公司 功能主治:新型的PARP抑制剂,用于治疗晚期卵巢癌,乳腺癌等 用法用量:用法用量  1、本品应在有抗肿瘤药物使用经验的医生的指导下使用。  2、推荐剂量:本品有150mg和100mg规格。  推荐剂量为300mg(2片150mg片剂),每日2次,相当于每日总剂量为600mg。  100mg片剂在剂量减少时使用。  3、患者应在含铂化疗结束后的8周内开始本品治疗,持续治疗直至疾病进展或发生不可接受的毒性反应。  4、给药方法:口服给药。  本品应整片吞服,不应咀嚼、压碎、溶解或掰断药片。  本品在进餐或空腹时均可服用。  5、漏服:如果患者漏服一剂药物,应按计划时间正常服用下一剂量。  6、避免同时使用强或中度CYP3A抑制剂,如果不能避免同时使用,减少奥拉帕利的剂量到:  6.1与强效CYP3A抑制剂同时使用,变更为100mg,每日两次。  6.2与中度CYP3A抑制剂同时使用,变更为150mg,每天两次。  7、对于有中度肾损害的患者,将奥拉帕尼的剂量减少到200mg,每天2次
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Olaparib(奥拉帕尼)国内上市时间,奥拉帕尼(Olaparib)在国外最早是在2014年12月由欧洲药品管理局(EMA)批准,随后,在2015年,美国食品药品监督管理局(FDA)也批准了奥拉帕利用于治疗BRCA突变的晚期卵巢癌,目前在国内已经上市,国内最早上市时间是2018年8月,由国家药品监督管理局(NMPA)批准上市。

Title: Olaparib (奥拉帕尼) Domestic Launch Date: A Breakthrough Treatment for Various Cancers

Introduction:

Olaparib, a revolutionary medication for the treatment of multiple types of cancer including ovarian, breast, pancreatic, prostate, and primary peritoneal carcinoma, has recently obtained approval for release in the domestic market. This article aims to provide accurate information regarding the domestic launch of Olaparib and its potential impact on cancer treatment.

1. The Rising Need for Effective Cancer Treatments:

Cancer remains one of the most prevalent and deadly diseases worldwide. Traditional treatment methods often prove inadequate, necessitating the development of innovative therapies. Olaparib, a poly ADP-ribose polymerase (PARP) inhibitor, demonstrates promising efficacy in targeting cancer cells and potentially improving patient outcomes.

2. Olaparib's Approval and Clinical Trials:

After rigorous and extensive research, Olaparib has successfully completed clinical trials and received regulatory approval for domestic distribution. The drug has shown remarkable results in treating ovarian, breast, pancreatic, prostate, and primary peritoneal cancers, making it a vital treatment option for patients suffering from these malignancies.

3. Benefits and Mechanism of Olaparib:

Olaparib functions by inhibiting the PARP enzymes, which play a crucial role in repairing DNA damage in cells. By inhibiting this repair process, Olaparib selectively targets and destroys cancer cells that have certain genetic mutations, such as BRCA1 and BRCA2. This mechanism of action makes Olaparib an invaluable treatment, particularly for patients with specific genetic alterations.

4. Efficacy and Potential Side Effects:

Clinical trials have demonstrated that Olaparib exhibits substantial efficacy in extending progression-free survival and overall survival rates in patients with advanced cancers. Additionally, the drug offers improved treatment options for patients who have limited responses to standard chemotherapy or radiation therapy. However, like any medication, Olaparib may be associated with certain side effects, which should be carefully monitored and managed by healthcare professionals.

Conclusion:

The domestic launch of Olaparib provides a ray of hope for patients battling ovarian, breast, pancreatic, prostate, and primary peritoneal cancers. This breakthrough treatment offers improved therapeutic outcomes and advances the field of precision medicine by targeting specific genetic mutations. As Olaparib becomes available to patients in the domestic market, it has the potential to transform cancer treatment strategies and significantly impact patient care.