【警告和注意事项】
•骨髓增生异常综合征/急性髓细胞白血病（MDS / AML）：<1.5％接触Lynparza单药治疗的患者发生，大多数事件都有致命的结果。 在基线和之后每月监测患者的血液毒性。 如果确认MDS / AML，则停止。（5.1）
•肺炎：在接触Lynparza的患者中发生率<1％，有些病例是致命的。 怀疑是肺炎的中断治疗。 如果确诊肺炎则停止。（5.2）
•胚胎 - 胎儿毒性：Lynparza可导致胎儿伤害。 建议胎儿的潜在风险并使用有效的避孕措施。 （5.3,8.1,8.3）
【INDICATIONS AND USAGE 】
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
Ovarian cancer
• for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. (1.1)
• for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.2, 2.3)
Breast cancer:
• in patients with deleterious or suspected deleteriou gBRCAm, human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (1.3, 2.4)
【DOSAGE AND ADMINISTRATION】
• To avoid substitution errors and overdose, do not substitute Lynparza tablets with Lynparza capsules on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation. (2.1)
• Recommended tablet dose is 300 mg taken orally twice daily with or without food. (2.2)
• Continue treatment until disease progression or unacceptable toxicity. (2.2)
• For adverse reactions, consider dose interruption or dose reduction. (2.5)
• For moderate renal impairment (CLcr 31-50 mL/min), reduce dose to 200 mg twice daily. (2.7)
【WARNINGS AND PRECAUTIONS】
• Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to Lynparza monotherapy and the majority of events had a fatal outcome. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed. (5.1)
• Pneumonitis: Occurred in <1% of patients exposed to Lynparza, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed. (5.2)
• Embryo-Fetal Toxicity: Lynparza can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. (5.3, 8.1, 8.3)
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详细处方信息以本药内容附件PDF文件（201912719185938.pdf）的“原文Priscribing Information”为准
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