{"product_id":"generic-repotrectinib-repodx-2","title":"REPODX (Repotrectinib)","description":"\u003ch3\u003e\u003cspan id=\"About_Repotrectinib\"\u003eAbout Repotrectinib\u003c\/span\u003e\u003c\/h3\u003e\u003cp\u003eRepotrectinib is an anti-cancer medication used for the treatment of non-small cell lung cancer. It is taken by mouth. Repotrectinib is an inhibitor of proto-oncogene tyrosine-protein kinase ROS1 (\u003ci\u003eROS1\u003c\/i\u003e) and of the tropomyosin receptor tyrosine kinases (TRKs) TRKA, TRKB, and TRKC.\u003csup id=\"cite_ref-Augtyro_FDA_label_1-3\" class=\"reference\"\u003e\u003c\/sup\u003e\u003c\/p\u003e\u003ch3\u003e\u003cspan id=\"Non-small_Cell_Lung_Cancer\"\u003eNon-small Cell Lung Cancer\u003c\/span\u003e\u003c\/h3\u003e\u003cp\u003eIndicated for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)\u003c\/p\u003e\u003cp\u003e160 mg PO qDay for 14 days, then increase to 160 mg PO BID\u003c\/p\u003e\u003cp\u003eContinue until disease progression or unacceptable toxicity\u003c\/p\u003e\u003ch3\u003e\u003cspan id=\"NTRK_Fusion-Positive_Solid_Tumors\"\u003eNTRK Fusion-Positive Solid Tumors\u003c\/span\u003e\u003c\/h3\u003e\u003cp\u003eIndicated for locally advanced, metastatic, or inoperable (surgical resection likely to result in severe morbidity) solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion that have progressed following treatment or have no satisfactory alternative treatment options\u003c\/p\u003e\u003cp\u003e160 mg PO qDay for 14 days, then increase to 160 mg PO BID\u003c\/p\u003e\u003cp\u003eContinue until disease progression or unacceptable toxicity\u003c\/p\u003e\u003ch3\u003e\u003cspan id=\"Dosage_Modifications\"\u003eDosage Modifications\u003c\/span\u003e\u003c\/h3\u003e\u003ch4\u003e\u003cspan id=\"Dose_reductions_for_adverse_reactions\"\u003eDose reductions for adverse reactions\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Current_dose_is_160_mg_PO_qDay\"\u003eCurrent dose is 160 mg PO qDay\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eFirst dose reduction: 120 mg PO qDay\u003c\/li\u003e\n\u003cli\u003eSecond dose reduction: 80 mg PO qDay\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Current_dose_is_160_mg_PO_BID\"\u003eCurrent dose is 160 mg PO BID\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eFirst dose reduction: 120 mg PO BID\u003c\/li\u003e\n\u003cli\u003eSecond dose reduction: 80 mg PO BID\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Central_nervous_system_effects\"\u003eCentral nervous system effects\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eIntolerable grade 2: Withhold until grade ≤1 or baseline; resume at same or reduced dose, as clinically appropriate\u003c\/li\u003e\n\u003cli\u003eGrade 3: Withhold until grade ≤1; resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eGrade 4: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Interstitial_lung_disease_ILD\"\u003eInterstitial lung disease (ILD)\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eSuspected ILD: Withhold\u003c\/li\u003e\n\u003cli\u003eConfirmed ILD: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Hepatotoxicity\"\u003eHepatotoxicity\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eALT or AST \u0026gt;3x ULN with concurrent total bilirubin \u0026gt;1.5x ULN (without cholestasis or hemolysis): Permanently discontinue\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Grade_3\"\u003eGrade 3\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until grade ≤1 or baseline\u003c\/li\u003e\n\u003cli\u003eResume at same dose if resolves within 4 weeks\u003c\/li\u003e\n\u003cli\u003eRecurrent grade 3 that resolves within 4 weeks: Resume at a reduced dose\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Grade_4\"\u003eGrade 4\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until grade ≤1 or baseline\u003c\/li\u003e\n\u003cli\u003eResume at reduced dose\u003c\/li\u003e\n\u003cli\u003eReaction does not resolve within 4 weeks OR recurrent grade 4: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Creatine_phosphokinase_CPK_elevation\"\u003eCreatine phosphokinase (CPK) elevation\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Withhold_until_resolves_to_baseline_or_25x_ULN_then\"\u003eWithhold until resolves to baseline or ≤2.5x ULN, then\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eCPK elevation \u0026gt;5x ULN: Resume at same dose\u003c\/li\u003e\n\u003cli\u003eCPK elevation \u0026gt;10x ULN or second occurrence of CPK elevation \u0026gt;5x ULN: Resume at reduced dose\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Hyperuricemia\"\u003eHyperuricemia\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eGrade 3 or 4: Withhold until signs and symptoms improve, then resume at same or reduced dose\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Other_significant_adverse_reactions\"\u003eOther significant adverse reactions\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eIntolerable grade 2 \u003ci\u003eor\u003c\/i\u003e grade 3 or 4: Withhold until grade ≤1 or baseline\u003c\/li\u003e\n\u003cli\u003eResolves within 4 weeks: Resume at same or reduced dose\u003c\/li\u003e\n\u003cli\u003eDoes not resolve within 4 weeks: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Renal_impairment\"\u003eRenal impairment\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eMild-to-moderate (eGFR 30-90 mL\/min): No dosage adjustment necessary\u003c\/li\u003e\n\u003cli\u003eSevere (eGFR \u0026lt;30 mL\/min) or patients on dialysis: Dosage guidance not provided; pharmacokinetic data unknown\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Hepatic_impairment\"\u003eHepatic impairment\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eMild (total bilirubin \u0026gt;1-1.5x ULN or AST \u0026gt;ULN): No dosage adjustment necessary\u003c\/li\u003e\n\u003cli\u003eModerate or severe (total bilirubin \u0026gt;1.5x ULN with any AST): Dosage guidance not provided; pharmacokinetic data unknown\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003e\u003cspan id=\"Dosing_Considerations\"\u003eDosing Considerations\u003c\/span\u003e\u003c\/h3\u003e\u003ch4\u003e\u003cspan id=\"Before_initiating\"\u003eBefore initiating\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eDiscontinue strong or moderate CYP3A4 inhibitors for 3-5 half-lives of CYP3A4 inhibitor\u003c\/li\u003e\n\u003cli\u003eEvaluate liver function tests and uric acid levels\u003c\/li\u003e\n\u003cli\u003eVerify pregnancy status of females of childbearing potential before initiating\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Patient_selection\"\u003ePatient selection\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"NSCLC\"\u003eNSCLC\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003e\u003cp\u003eVerify presence of ROS1 rearrangements in tumor specimens\u003c\/p\u003e\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Other_solid_tumors\"\u003eOther solid tumors\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eVerify presence of NTRK1\/2\/3 rearrangements in tumor specimens\u003c\/li\u003e\n\u003cli\u003eConsider treatment without confirmation of NTRK1\/2\/3 rearrangements in patients with secretory breast cancer or mammary analogue secretory cancer\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"BIGBEAR Pharma, Laos PDR","offers":[{"title":"Default Title","offer_id":44797953146923,"sku":"RL3020241020","price":0.0,"currency_code":"AMD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0701\/3528\/3755\/files\/2024-10-1224-jpg.webp?v=1787022193","url":"https:\/\/xomeds.com\/products\/generic-repotrectinib-repodx-2","provider":"XOMEDS","version":"1.0","type":"link"}