OSPHENA (ospemifene) tablet, film coated
[Shionogi Inc.]
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use OSPHENA safely and effectively. See full prescribing information for OSPHENA.
OSPHENATM (ospemifene) tablets, for oral use
Initial U.S. Approval: 2013
WARNING: ENDOMETRIAL CANCER AND
CARDIOVASCULAR DISORDERS
See full prescribing information for complete boxed warning.
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. [see Warnings and Precautions (5.2)].
Estrogen-alone therapy has an increased risk of stroke and deep vein thrombosis (DVT). OSPHENA 60 mg had cerebral thromboembolic and hemorrhagic stroke incidence rates of 0.72 and 1.45 per thousand women, respectively vs. 1.04 and 0 per thousand women, respectively in placebo. For deep vein thrombosis, the incidence rate for OSPHENA 60 mg is 1.45 per thousand women vs. 1.04 per thousand women in placebo [see Warnings and Precautions (5.1)].
 美国食品药品管理局(FDA)宣布批准盐野义制药公司的口服药物Osphena(ospemifene)用于治疗女性绝经期外阴和阴道萎缩引起的中至重度性交疼痛。Osphena是具有组织选择效应的雌激素受体激动剂/拮抗剂，可代替阴道或口服甾体雌激素。
3项临床研究在1889例有外阴和阴道萎缩症状的绝经后女性中确立了Osphena的安全性和有效性。患者随机接受Osphena或安慰剂治疗。治疗12周后，前2项研究的结果显示，Osphena组女性性交疼痛的改善比安慰剂组显著。第3项研究结果支持Osphena长期治疗性交疼痛的安全性。
临床研究显示，与安慰剂组相比，Osphena 60 mg每日1次组的最常见不良事件包括潮热(7.5% vs 2.6%)、阴道分泌物(3.8% vs 0.3%)、肌肉痉挛(3.2% vs 0.9%)、多汗(1.6% vs 0.6%)和外阴分泌物(1.3% vs 0.1%)。
Osphena的黑框警告指出，由于无对抗雌激素的作用，使用Osphena可刺激子宫内膜，进而增加子宫内膜癌发生的风险。子宫内膜增生是子宫内膜癌先兆，在雌激素治疗基础上加用孕激素可降低子宫内膜增生的风险。黑框警告还提醒，接受单纯雌激素治疗的女性有发生深静脉血栓形成和卒中的风险。
接受Osphena治疗的女性在出现异常阴道出血时应就诊。应根据每个女性的治疗目标与风险给予最短期的Osphena。
INDICATIONS AND USAGE
OSPHENA is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause (1)
DOSAGE AND ADMINISTRATION
One tablet taken orally once daily with food (2.1)
DOSAGE FORMS AND STRENGTHS
Tablet: 60 mg (3)
CONTRAINDICATIONS
Undiagnosed abnormal genital bleeding (4)
Known or suspected estrogen-dependent neoplasia (4, 5.2)
Active DVT, pulmonary embolism (PE), or a history of these conditions (4, 5.1)
Active arterial thromboembolic disease (for example, stroke and myocardial infarction [MI]), or a history of these conditions (4, 5.1)
Known or suspected pregnancy (4, 8.1)
WARNINGS AND PRECAUTIONS
Venous Thromboembolism: Risk of DVT and pulmonary embolism (5.1)
Known, suspected, or history of breast cancer (5.2)
Severe Hepatic Impairment (5.3, 8.7, 12.3)
ADVERSE REACTIONS
Adverse reactions (≥1 percent) include: hot flush, vaginal discharge, muscle spasms, genital discharge, hyperhidrosis. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Inc. at 1-855-OSPHENA (1-855-677-4362) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Do not use estrogens or estrogen agonist/antagonist concomitantly with OSPHENA (7.1,12.3)
Do not use fluconazole concomitantly with OSPHENA. Fluconazole increases serum concentrations of OSPHENA (7.2, 12.3)
Do not us