{"product_id":"lucicapiva-capivasertib","title":"LuciCapiva (Capivasertib)","description":"\u003ch2\u003eAbout Capivasertib\u003c\/h2\u003e\u003cp\u003eCapivasertib is an orally bioavailable, small-molecule inhibitor of all three AKT isoforms. Capivasertib used in combination with fulvestrant , is indicated for adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer with one or more PIK3CA\/AKT1\/PTEN-alterations,  following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within twelve months of completing adjuvant therapy.\u003csup id=\"cite_ref-Truqap_FDA_label_4-3\" class=\"reference\"\u003e\u003c\/sup\u003e\u003c\/p\u003e\u003ch3\u003eBreast Cancer\u003c\/h3\u003e\u003cp\u003eIndicated in combination with fulvestrant for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with ≥1 PIK3CA\/AKT1\/PTEN-alterations, following progression on at least 1 endocrine-based regimen in the metastatic setting; or recurrence during, or within 12 months after completing, adjuvant therapy\u003c\/p\u003e\u003ch4\u003eCapivasertib weekly dose schedule\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e400 mg PO BID (~12 hr apart) x 4 consecutive days followed by 3 days off\u003c\/li\u003e\n\u003cli\u003eRepeat weekly schedule until disease progression or unacceptable toxicity\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eFulvestrant regimen during clinical trial\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e28-day cycles\u003c\/li\u003e\n\u003cli\u003eCycle 1: 500 mg IM on Days 1 and 15\u003c\/li\u003e\n\u003cli\u003eSubsequent cycles: 500 mg IM on Day 1\u003c\/li\u003e\n\u003cli\u003ePremenopausal and perimenopausal women: Administer a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards\u003c\/li\u003e\n\u003cli\u003eMen: Consider administering a LHRH agonist according to current clinical practice standards\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eDosage Modifications\u003c\/h3\u003e\u003ch4\u003eDose reductions for adverse reactions\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eFirst dose reduction: 320 mg BID x 4 days followed by 3 days off\u003c\/li\u003e\n\u003cli\u003eSecond dose reduction: 200 mg BID x 4 days followed by 3 days off\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHyperglycemia\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eNote that recommendations are based on fasting glucose (FG) rather than random glucose\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eFG \u0026gt;ULN-160 mg\/dL (8.9 mmol\/L) or hemoglobin A1C (HbA1C) \u0026gt;7%\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003eConsider initiation or intensification of oral antidiabetic treatment\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eFG 161-250 mg\/dL (9-13.9 mmol\/L)\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until FG decrease to ≤160 mg\/dL (≤8.9 mmol\/L)\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in ≤28 days, resume at same dose\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in \u0026gt;28 days, resume at 1 lower dose\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eFG 251-500 mg\/dL (14-27.8 mmol\/L)\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until FG decrease to ≤160 mg\/dL (≤8.9 mmol\/L)\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in ≤28 days, resume at 1 lower dose\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in \u0026gt;28 days, permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eFG \u0026gt;500 mg\/dL (\u0026gt;27.8 mmol\/L) or life-threatening sequelae of hyperglycemia at any FG level\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eLife-threatening sequelae of hyperglycemia or if FG persists at ≥500 mg\/dL after 24 hr: Permanently discontinue\u003c\/li\u003e\n\u003cli\u003eIf FG ≤500 mg\/dL (or ≤27.8 mmol\/L) within 24 hr, follow above guidance for relevant grade\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eDiarrhea\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 2\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until recovery to Grade ≤1\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in ≤28 days: Resume at same dose or 1 lower dose as clinically indicated\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in \u0026gt;28 days: Resume at 1 lower dose\u003c\/li\u003e\n\u003cli\u003eFor recurrence: Reduce by 1 lower dose\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 3\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until recovery to Grade ≤1\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in ≤28 days: Resume at same dose or 1 lower dose as clinically indicated\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in \u0026gt;28 days: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 4\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003ePermanently discontinue\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eCutaneous reactions\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 2\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until recovery to Grade ≤1 then resume at same dose\u003c\/li\u003e\n\u003cli\u003ePersistent or recurrent: Reduce by 1 lower dose\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 3\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until recovery to Grade ≤1\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in ≤28 days: Resume at same dose\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in \u0026gt;28 days: Resume at 1 lower dose\u003c\/li\u003e\n\u003cli\u003eFor recurrence: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 4\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003ePermanently discontinue\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eOther adverse reactions\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 2\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until recovery to Grade ≤1\u003c\/li\u003e\n\u003cli\u003eResume at same dose\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 3\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until recovery to Grade ≤1\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in ≤28 days: Resume at same dose\u003c\/li\u003e\n\u003cli\u003eIf recovery occurs in \u0026gt;28 days: Resume at 1 lower dose\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 4\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003ePermanently discontinue\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eStrong and moderate CYP3A inhibitors\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eStrong inhibitor: Avoid coadministration; if unavoidable, reduce dose to 320 mg BID x 4 days followed by 3 days off\u003c\/li\u003e\n\u003cli\u003eModerate inhibitor: Reduce dose to 320 mg PO BID x 4 days followed by 3 days off\u003c\/li\u003e\n\u003cli\u003eAfter discontinuing strong or moderate CYP3A inhibitor, resume capivasertib dosage (after 3-5 half-lives of CYP3A inhibitor) that was taken before initiating strong or moderate CYP3A inhibitor\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eRenal impairment\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eMild-to-moderate (CrCl 30-89 mL\/min): No dosage adjustment required\u003c\/li\u003e\n\u003cli\u003eSevere (CrCl 15-29 mL\/min): Not studied\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHepatic impairment\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eMild (bilirubin ULN \u003cb\u003eor\u003c\/b\u003e bilirubin \u0026gt;1-1.5x ULN and any AST): No dosage adjustment required\u003c\/li\u003e\n\u003cli\u003eModerate (bilirubin \u0026gt;1.5-3x ULN and any AST): Monitor for adverse reactions due to potential increased capivasertib exposure\u003c\/li\u003e\n\u003cli\u003eSevere (bilirubin \u0026gt;3x ULN and any AST): Not studied\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Lucius Pharmaceuticals (Lao) Co., Ltd","offers":[{"title":"Default Title","offer_id":44797955571755,"sku":"RL3120250101","price":0.0,"currency_code":"AMD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0701\/3528\/3755\/files\/2024-12-1022.jpg?v=1787022236","url":"https:\/\/xomeds.com\/products\/lucicapiva-capivasertib","provider":"XOMEDS","version":"1.0","type":"link"}