部份中文醋酸舍瑞林处方资料（仅供参考）
英文名：ZOLADEX (goserelin acetate implant)
中文名：醋酸舍瑞林缓释植入剂
剂型：缓释植入剂
生产厂家：TERSERA THERAPEUTICS
药品介绍
ZODEADX（goserelin）是一种可在体内逐渐进行生物降解的多聚缓释植入剂。无菌、白色或乳白色柱形，含醋酸戈舍瑞林（相当于3.6毫克戈舍瑞林），置于一注射器中，单剂量给药。
ZODEADX（醋酸舍瑞林[goserelin acetate]）植入剂；108mg
首次美国批准：1996
作用机理
ZOLDADX是一种合成的二十肽类似物GnRH。在生物降解制剂中，ZOLDADX作为垂体促性腺激素分泌抑制剂。在动物和体外研究中，给予戈斯雷林导致激素敏感性二甲基苯蒽（DMBA）诱导的大鼠乳腺肿瘤和邓宁R3327前列腺肿瘤消退或抑制生长。
适应症及用法
ZOLDADX是促性腺激素释放激素（GnRH）激动剂，其特征在于：
氟他胺联合应用治疗局限性局限性前列腺癌
用作姑息性治疗晚期前列腺癌
剂量与给药
ZOLADEX的剂量为10.8mg，应每12周皮下注射到脐带下方的前腹壁内。
剂型和强度
植入物：108mg
禁忌症
超敏反应。
怀孕。
警告和注意事项
•肿瘤闪光现象：在使用ZOLADEX治疗的最初几周内，肿瘤症状可能出现短暂恶化，包括输尿管梗阻和脊髓压迫。监测有肿瘤耀斑并发症风险的患者。
超敏反应：在接受Geelelin植入的患者中已经报道过全身过敏性反应。
•高血糖和糖尿病：据报道，在接受GnRH类似物的男性中，高血糖和患糖尿病的风险增加。根据目前的临床实践，监测血糖水平并进行管理。
•心血管疾病：据报道，与男性使用GnRH类似物有关，心肌梗塞、心脏猝死和中风的风险增加。心血管疾病的监测和管理，根据目前的临床实践。
·对QT/QTc间期的影响：雄激素剥夺治疗可延长QT间期。考虑风险和收益。
注射部位损伤：注射部位损伤和血管损伤。
不良反应
最常见的、临床上显著的不良反应发生在超过10%的男性身上：潮热、性功能障碍、勃起减少和下尿路症状。
肿瘤耀斑可在佐拉迪治疗开始时发生。
为了报告可疑的不良反应，请在1-800至-23至699或A31-FDA-1088或www. FDA.GOV/MeWAT上联系阿司匹林。
药物相互作用
没有
在特定人群中的使用
哺乳期母亲：考虑到母亲对药物的重要性，停止药物或护理。
•无信息可用于儿科患者.
老年医学
肾脏和肝脏损害：无需剂量调整。
如何供应/储存和搬运
ZOLADEX 10.8mg植入物作为无菌且完全可生物降解的D,L-乳酸和乙醇酸共聚物(12.82-14.76mg/剂量)提供，该共聚物在装有14-规格×36+/-0.5mm硅化皮下注射器的一次性注射器设备中浸渍了相当于10.8mg的醋酸戈瑟林。带保护套的针头[安全系统]注射器（NDC 0310-0951-30）。该设备是无菌的，并进入一个密封，防光，防潮，铝箔层压袋包含干燥剂胶囊。常温贮存（不超过25°C [ 77°F ]）。
ZOLADEX 10.8 MG PFS DS  GOSERELIN ACETATE  TERSERA THERAPEUTICS LLC  70720095130
ZOLADEX 3.6MG PFS DS   GOSERELIN ACETATE   TERSERA THERAPEUTICS LLC  70720095036
ZOLADEX 10.8MG SAFETY SYR 1/EA    GOSERELIN ACETATE   TERSERA THERAPEUTICS  70720-0951-30
ZOLADEX 3.6MG SAFETY SYR 1/EA     GOSERELIN ACETATE   TERSERA THERAPEUTICS  70720-0950-36
完整说明书附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4FF62A5A-77BA-4BF5-0497-95CCCA842315 
Zoladex (10.8mg goserelin acetate implant)
Company: AstraZeneca
Approval Status: Approved January 1996
Treatment for: prostate cancer
Areas: Diabetes / Endocrinology; Urology & Kidneys; Cancer & Oncology
General Information
The original 3.6 mg formulation of Zoladex has been available since 1989 as a monthly implant. The new formation, 10.8 mg goserelin acetate implant given every three months, offers greater convenience to subjects choosing treatment with a luteinizing-hormone-releasing hormone (LHRH) analogue. The 3.6 mg formulation of Zoladex was shown to be as effective as orchiectomy (surgical castration) in controlling the spread of prostate cancer, thus offering men a choice between medical treatment and surgery.
The growth of prostate cancer can be stimulated by the male hormone testosterone. Treatment with Zoladex as a subcutaneous injection results in a decline in testosterone, which then reduces stimulation of hormone-responsive prostate tumors.
The 3-month formulation of Zoladex is a cylindrical implant with a 1.5 mm diameter that contains 10.8 mg of goserelin. Given by subcutaneous injection, the biodegradable implant slowly dissolves, delivering therapeutic levels of the drug continuously over a period of 12 weeks.
Clinical Results
In controlled studies of subjects with advanced prostate cancer, the Zoladex 10.8 mg formulation produced pharmacodynamically similar effect in terms of testosterone suppression to that achieved with the 3.6 mg formulation.
Side Effects
The most frequently reported adverse effects in clinical trials with the 10.8 mg formulation were hot flashes and pain.
Mechanism of Action
Zoladex is an analogue of naturally occurring LHRH. Continuous administration of Zoladex results in a significant decline in testosterone production by the testicles. This reduces testosterone stimulation of prostate cancer growth.
Additional Information
The once-a-month Zoladex 3.6 mg formulation was recently cleared by the FDA for the treatment of advanced breast cancer in premenopausal and perimenopausal women. Since 1993, Zoladex has also been used as a treatment for endometriosis, a noncancerous gynecological condition affecting an estimated five million women in the United States.
Prostate cancer is the most common cancer (other than skin cancers) among men in the United States. According to the American Cancer Society, some 244,000 men will be diagnosed with the disease in 1995, and 40,400 men will die of it.