PIQRAY 是一種激激抑制劑，與Fulvestrant聯合用於治療在內分泌療法後進展的成人激素受體（HR）陽性、第二型人類表皮生長因子受體（HER2）陰性、PIK3CA 突變、晚期或轉移性乳腺癌。
PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
PIQRAY 通過抑制 PI3K 的活性，特別是 PIK3CA 突變變，來阻止腫瘤細胞的生長和存活。
PIQRAY inhibits the activity of the PI3K enzyme, particularly the mutated PIK3CA enzyme, thereby preventing tumor cell growth and survival.
PIQRAY 口服後吸收迅速，達到 Peak 濃度的時間約為 2 至 4 小時。代謝主要通過肝臟臟 CYP3A4 進行。
Following oral administration, PIQRAY is rapidly absorbed, with peak concentrations reached in approximately 2 to 4 hours. Metabolism primarily occurs through the hepatic enzyme CYP3A4.
對 PIQRAY 或其任何成分有嚴重過敏反應的患者禁用。
PIQRAY is contraindicated in patients with severe hypersensitivity to PIQRAY or any of its components.
PIQRAY 可對胎兒造成傷害，建議患者在治療期間及最後一次服藥後至少 1 週內使用有效的避孕措施。
PIQRAY can cause fetal harm. Patients are advised to use effective contraception during treatment and for at least one week after the last dose.
建議哺乳期女性在使用 PIQRAY 治療期間不要哺乳。
Women are advised not to breastfeed during treatment with PIQRAY.
常見副作用包括高血糖、皮疹、疲勞、腹瀉、噁心和食慾減退。
Common adverse reactions include hyperglycemia, rash, fatigue, diarrhea, nausea, and decreased appetite.
- 起始劑量：每天一次 300 毫克（兩片 150 毫克錠劑）
- 第一次減量：每天一次 250 毫克（1片 200 毫克錠劑和1片 50 毫克錠劑）
- 第二次減量：每天一次 200 毫克（1片 200 毫克錠劑）
- Starting dose: 300 mg once daily (two 150 mg tablets)
- First-dose reduction: 250 mg once daily (one 200 mg tablet and one 50 mg tablet)
- Second-dose reduction: 200 mg once daily (one 200 mg tablet)
目前尚未確定 PIQRAY 在小兒患者中的安全性和有效性。
The safety and efficacy of PIQRAY in pediatric patients have not been established.
對於輕度或中度腎功能損害的患者，無需調整劑量。對於重度腎功能損害的患者，應慎用 PIQRAY。
No dose adjustment is required for patients with mild or moderate renal impairment. PIQRAY should be used with caution in patients with severe renal impairment.
對於輕度或中度肝功能損害的患者，無需調整劑量。對於重度肝功能損害的患者，應慎用 PIQRAY。
No dose adjustment is required for patients with mild or moderate hepatic impairment. PIQRAY should be used with caution in patients with severe hepatic impairment.