2.1 Treatment of postmenopausal women with estrogen receptor-positive locally advanced or metastatic breast cancer who have experienced disease recurrence despite adjuvant anti-estrogenic therapy, or whose disease has worsened despite anti-estrogenic therapy. 2.2 For patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer, this product can be combined with palbociclib for those who have previously received endocrine therapy. Note: Premenopausal/pre-/perimenopause women receiving endocrine therapy should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist. 2.3 This product, combined with abemaciclib, can treat women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer whose disease has worsened after endocrine therapy.
藥理
Anticancer- Hormone antagonists and related agents
藥動學
禁忌症
懷孕分類
Fulvestrant is contraindicated during pregnancy. Animal studies have shown reproductive toxicity, including an increased incidence of fetal malformations and death. Patients who become pregnant while using fulvestrant should be informed of the potential risks to the fetus and the risk of miscarriage.
哺乳分類
Breastfeeding must be discontinued during treatment with fulvestrant. Fulvestrant is secreted into the milk of nursing rats. Whether fulvestrant is secreted into human milk is unknown. Given that fulvestrant may cause serious adverse reactions in breastfed infants, it is contraindicated during breastfeeding.
副作用
劑量和給藥方法
slow IM in the buttocks 5 ml twice consecutively,1-2 minutes per injection,once on each side.
小兒調整劑量
Fulvestrant is not recommended for use in children or adolescents because its safety and efficacy in this age group have not been established.
腎功能調整劑量
1.Clcr?30 mL/min:No dose adjustment is required for patients with mild to moderate renal impairment . 2.Clcr<30 mL/min:The safety and efficacy of this drug in patients with severe renal impairment have not been evaluated;caution should be exercised when using it in these patients.
肝功能調整劑量
1.mild to moderate hepatic impairment do not require dose adjustment;caution should be exercised when using fulvestrant as exposure may be increased. 2.Data on the use of this drug in patients with severe hepatic impairment have not been established.