阿培利司/阿培利斯/阿博利布(Alpelisib/Piqray)中文说明书

【印度代购提示，本品适应症】

用于经基于内分泌的治疗方案治疗后疾病进展的携带PIK3CA突变的激素受体阳性、人表皮生长因子受体-2阴性(HR+/HER2-)的晚期或转移性乳腺癌患者。

Patients with advanced or metastatic breast cancer who are hormone receptor positive and human epidermal growth factor receptor-2 negative (HR+/HER2-) with PIK3CA mutations and whose disease progresses after treatment with an endocrinology-based therapy regimen.

【印度代购提示，本品作用机制】

阿培利司是一种磷脂酰肌醇-3激酶（PI3K）抑制剂，能够抑制PI3Kα（PIK3CA）活性，诱导乳腺癌细胞中雌激素受体的转录增加，与Fulvestrant联合应用具有协同的抗肿瘤活性。

Aperis is a phosphatidlinositol-3 kinase (PI3K) inhibitor that inhibates PI3Kα (PIK3CA) activity and induces increased transcription of estrogen receptors in breast cancer cells. When combined with Fulvestrant, apelis has synergistic antitumor activity.

【印度代购提示，本品药品规格】

片剂，50mg;150mg;200mg

【印度代购提示，本品副作用】

恶心，呕吐，极度疲劳，食欲下降，胃灼热，脱发，头痛，发痒，皮肤干燥，口干，阴道干燥，发热，手臂或腿肿胀，皮疹，腹泻等。

【印度代购提示，本品用法用量】

推荐的Alpelisib剂量为300mg(两片150mg药片)，每天一次，与食物一起口服。整片吞服，不能咀嚼、碎裂、破碎药片。对于不良反应，请考虑剂量中断，剂量减少或停药。 (1)说明书推荐剂量为每日口服一次300mg，每日同一时间服用。给药至无法耐受或耐药。 (2)与氟维司群联合用药，推荐剂量的氟维司群在第1天，第15天和第29天施用500mg，之后每月一次。 阿培利司剂量调整： 起始剂量每日一次300mg 首次减量每日一次250mg 第二次减量每日一次200mg (1)胰腺炎只允许减少剂量一次。 (2)如果无法耐受200mg剂量，则停止阿培利司治疗。

The recommended dose of Alpelisib is 300mg(two 150mg tablets), taken orally once daily with food. Swallow the tablet whole, do not chew, break or shatter the tablet. For adverse reactions, consider dose interruption, dose reduction, or withdrawal. (1) The recommended dosage is 300mg once daily, taken at the same time each day. The drug is administered until it is intolerable or resistant. (2) In combination with fluvestrin, the recommended dose of 500mg of fluvestrin was administered on days 1, 15, and 29, and thereafter once a month. Dose adjustment for apelis: starting dose 300mg once daily First dose reduction 250mg daily Second dose reduction 200mg daily (1) Only one dose reduction for pancreatitis is allowed. (2) Discontinue apelis treatment if the dose of 200mg is not tolerated.