{"product_id":"generic-entrectinib-entredx-200","title":"ENTREDX 200 (entrectinib)","description":"\u003cdiv class=\"collapse-more\"\u003e\u003ch3\u003eNon-small Cell Lung Cancer\u003c\/h3\u003e\u003c\/div\u003e\u003cp\u003eIndicated for metastatic non-small cell lung cancer (NSCLC) in adults whose tumors are ROS1-positive\u003c\/p\u003e\u003cp\u003e600 mg PO qDay\u003c\/p\u003e\u003cp\u003eContinue until disease progression or unacceptable toxicity\u003c\/p\u003e\u003ch3\u003eNeurotrophic Tyrosine Receptor Kinase Gene Fusion Solid Tumors\u003c\/h3\u003e\u003cp\u003eIndicated for patients with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and progressed following treatment or have no satisfactory alternative therapy\u003c\/p\u003e\u003cp\u003e600 mg PO qDay\u003c\/p\u003e\u003cp\u003eContinue until disease progression or unacceptable toxicity\u003c\/p\u003e\u003ch3\u003eDosage Modifications\u003c\/h3\u003e\u003ch4\u003eDosage modifications for adverse reactions\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eFirst dose reduction: 400 mg qDay\u003c\/li\u003e\n\u003cli\u003eSecond dose reduction: 200 mg qDay\u003c\/li\u003e\n\u003cli\u003ePermanently discontinue if toxicities persist or recur following 2 dose reductions\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eCongestive heart failure\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eGrade 2 or 3: Withhold until recovered to Grade ≤1; resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eGrade 4: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eCentral nervous system effects\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eIntolerable Grade 2: Withhold until recovered to Grade ≤1; resume at reduced dose, as clinically appropriate\u003c\/li\u003e\n\u003cli\u003eGrade 3: Withhold until recovered to Grade ≤1; resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eGrade 4: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHepatoxicity\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eGrade 3\u003cul\u003e\n\u003cli\u003eWithhold until recovered to Grade ≤1; resume at reduced dose;\u003c\/li\u003e\n\u003cli\u003eIf resolution occurs within 4 weeks, resume at same dose\u003c\/li\u003e\n\u003cli\u003eIf adverse reaction persists after 4 weeks, permanently discontinue\u003c\/li\u003e\n\u003cli\u003eFor recurrent Grade 3 events that resolve within 4 weeks, resume at a reduced 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\n\u003cli\u003eWithhold until recovered to Grade ≤1; resume at reduce dose;\u003c\/li\u003e\n\u003cli\u003eIf adverse reaction does not resolve within 4 weeks or Grade 4 events recurs, permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eElevated ALT or AST\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003eALT or AST \u0026gt;3x ULN with concurrent total bilirubin \u0026gt;1.5x ULN (in the absence of cholestasis or hemolysis): Permanently discontinue\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHyperuricemia\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eSymptomatic or Grade 4: Initiate urate-lowering therapy; withhold until improvement of signs or symptoms; resume at same or reduced dose\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003eQTc prolongation\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eQTc \u0026gt;500 ms\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until QTc interval recovers to baseline\u003c\/li\u003e\n\u003cli\u003eResume at same dose if causes of QT prolongation are identified and corrected\u003c\/li\u003e\n\u003cli\u003eResume at reduced dose if other causes of QT prolongation are not identified\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eLife-threatening arrhythmia\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003eTorsade de pointes; polymorphic ventricular tachycardia; signs\/symptoms of serious arrhythmia: Permanently discontinue\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eVision disorders\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eGrade ≥2: Withhold until improvement or stabilization; resume at same dose or reduced dose, as clinically appropriate\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003eAnemia or neutropenia\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eGrade 3 or 4: Withhold until recovery to Grade≤2; resume at same or reduced dose, as clinically appropriate\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003eOther clinically relevant adverse reactions\u003c\/h4\u003e\u003cul\u003e\u003cli\u003e\n\u003ch5\u003eGrade 3 or 4\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold until adverse reaction resolves to Grade 1 or baseline\u003c\/li\u003e\n\u003cli\u003eResume at same or reduced dose if resolved within 4 weeks\u003c\/li\u003e\n\u003cli\u003ePermanently discontinue if adverse reaction does not resolve within 4 weeks or Grade 4 events recurs\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003eCoadministration of moderate and strong CYP3A inhibitors\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eAvoid coadministration\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eIf coadministration is unavoidable, reduce entrectinib dose as follows:\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eModerate CYP3A Inhibitors: 200 mg PO qDay\u003c\/li\u003e\n\u003cli\u003eStrong CYP3A Inhibitors: 100 mg PO qDay\u003c\/li\u003e\n\u003cli\u003eAfter discontinuation of strong or moderate CYP3A inhibitor for 3-5 elimination half-lives, resume entrectinib dose taken prior to initiating the CYP3A inhibitor\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eRenal impairment\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eMild-to-moderate (CrCl 30 to \u0026lt;90 mL\/min): No dosage adjustment necessary\u003c\/li\u003e\n\u003cli\u003eSevere (CrCl \u0026lt;30 mL\/min): Not studied\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHepatic impairment\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eMild (total bilirubin ≤1.5x ULN): No dosage adjustment necessary\u003c\/li\u003e\n\u003cli\u003eModerate-to-severe (total bilirubin \u0026gt;1.5x ULN): Not studied; consider risk-benefit profile prior to determining whether to administer therapy to patients with moderate to severe hepatic impairment; monitor for adverse reactions in patients with hepatic impairment more frequently; these patients may be at increased risk for adverse reactions\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eDosing Considerations\u003c\/h3\u003e\u003ch4\u003ePatient selection\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eNSCLC: Presence of ROS1 rearrangement\u003c\/li\u003e\n\u003cli\u003eLocally advanced or metastatic solid tumors: Presence of a NTRK gene fusion\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"BIGBEAR Pharma, Laos PDR","offers":[{"title":"Default Title","offer_id":44797951770667,"sku":"RL2020231212780","price":0.0,"currency_code":"AMD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0701\/3528\/3755\/files\/2023-12-1268.jpg?v=1787022160","url":"https:\/\/xomeds.com\/products\/generic-entrectinib-entredx-200","provider":"XOMEDS","version":"1.0","type":"link"}