第十一章 奥培米芬片 OSPHENA (ospemifene) FDA药品说明书翻译.pdf

FULL PRESCRIBING INFORMATION WARNING: ENDOMETRIAL CANCER AND CARDIOVASCULAR DISORDERS 警告：子宫内膜癌和心血管疾病 Endometrial Cancer 子宫内膜癌 OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy reduces the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2)]. 本药是一种具有组织选择性作用的雌激素激动药和拮抗药。在子宫内膜中，具有雌激素激 动作用。使用非对抗性雌激素的女性(有子宫)患子宫内膜癌的风险增加。雌激素治疗时合用 孕激素可降低子宫内膜增生的风险，而子宫内膜增生可能是子宫内膜癌的先兆。未经确诊 的持续或复发性生殖器异常出血的绝经后妇女应采取适当的诊断措施以排除恶性肿瘤，包 括定向和随机的子宫内膜取样。 Cardiovascular Disorders 心血管疾病 There is a reported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) who received daily oral conjugated estrogens (CE) [0.625 mg]-alone therapy over 7.1 years as part of the Women’s Health Initiative (WHI) [see Warnings and Precautions (5.1)]. 有绝经后妇女(50-79 岁)，遵从妇女健康倡议(WHI)每日接受口服结合雌激素(CE，0.625mg) 单药治疗7.1 年，卒中和深静脉血栓形成(DVT)风险增加的报道。 In the clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 0.72 and 1.45 per thousand women, respectively in OSPHENA 60 mg treatment group and 1.04 and 0 in placebo [see Warnings and Precautions (5.1)]. The incidence of DVT was 1.45 per thousand women in OSPHENA 60 mg treatment group and 1.04 per thousand women in placebo [see Warnings and Precautions (5.1)]. OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman. 临床试验(治疗时间