{"product_id":"generic-larotrectinib-lucilaro","title":"PRASEDX (Pralsetinib)","description":"\u003ch2\u003eAbout  Pralsetinib\u003c\/h2\u003e\u003cp\u003ePralsetinib is a tyrosine kinase inhibitor. It is taken by mouth.\u003c\/p\u003e\u003cp\u003ePralsetinib is a medication approved\u003csup id=\"cite_ref-10\" class=\"reference\"\u003e\u003c\/sup\u003e for RET mutation-positive medullary thyroid cancer (MTC)  and RET fusion-positive differentiated thyroid cancer (DTC) refractory to radioactive iodine (RAI) therapy.\u003c\/p\u003e\u003cp\u003ePralsetinib is indicated for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) .\u003csup id=\"cite_ref-FDA_pralsetinib_12-4\" class=\"reference\"\u003e\u003c\/sup\u003e\u003c\/p\u003e\u003ch2\u003eNon-Small Cell Lung Cancer\u003c\/h2\u003e\u003cp\u003eIndicated for metastatic rearranged during transfection (RET) gene-positive non-small cell lung cancer (NSCLC)\u003c\/p\u003e\u003cp\u003e400 mg PO qDay on an empty stomach\u003c\/p\u003e\u003cp\u003eContinue until disease progression or until unacceptable toxicity\u003c\/p\u003e\u003ch2\u003eMedullary Thyroid Cancer\u003c\/h2\u003e\u003cp\u003eIndication was withdrawn in the U.S. by manufacturer on July 10, 2023\u003c\/p\u003e\u003cp\u003eThe decision was made to remove the indication after the confirmatory trial could not fulfill the postmarketing requirement\u003c\/p\u003e\u003ch2\u003eThyroid Cancer\u003c\/h2\u003e\u003cp\u003eIndicated for advanced or metastatic RET-fusion positive thyroid cancer in adults who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate)\u003c\/p\u003e\u003cp\u003e400 mg PO qDay\u003c\/p\u003e\u003cp\u003eContinue until disease progression or until unacceptable toxicity\u003c\/p\u003e\u003ch2\u003eDosage Modifications\u003c\/h2\u003e\u003ch3\u003eDosage modifications for adverse reactions\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eFirst dose reduction: 300 mg PO qDay\u003c\/li\u003e\n\u003cli\u003eSecond dose reduction: 200 mg PO qDay\u003c\/li\u003e\n\u003cli\u003eThird dose reduction: 100 mg PO qDay\u003c\/li\u003e\n\u003cli\u003eUnable to tolerate 100 mg qDay: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eInterstitial lung disease (ILD)\/pneumonitis\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eGrade 1 or 2: Withhold until resolution; resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eGrade 3 or 4 or recurrent ILD\/pneumonitis: Permanent discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHypertension\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eGrade 3: Withhold for persistent Grade 3 hypertension despite optimal antihypertensive therapy; resume at reduced dose once hypertension controlled\u003c\/li\u003e\n\u003cli\u003eGrade 4: Discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHepatoxicity\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eGrade 3 or 4: Withhold and monitor AST\/ALT once weekly until resolution to Grade ≤1\u003c\/li\u003e\n\u003cli\u003eResume at reduced dose\u003c\/li\u003e\n\u003cli\u003eIf Grade ≥3 hepatotoxicity recurs, discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHemorrhagic events\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eGrade 3 or 4: Withhold until recovery to baseline or Grade ≤1\u003c\/li\u003e\n\u003cli\u003eDiscontinue for severe or life-threatening hemorrhagic events\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eOther adverse reactions\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eGrade 3 or 4: Withhold until recovery to Grade ≤2; resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eRecurrent Grade 4: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eStrong CYP3A4 inhibitors or combined P-gp and strong CYP3A4 inhibitors\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eAvoid coadministration\u003c\/li\u003e\n\u003cli\u003e\n\u003ch4\u003eDosage modification if unable to avoid combined P-gp and strong CYP3A4 inhibitors\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003eIf current pralsetinib dose is 300 or 400 mg qDay, reduce to 200 mg qDay\u003c\/li\u003e\n\u003cli\u003eIf current pralsetinib dose is 200 mg qDay, reduce to 100 mg qDay\u003c\/li\u003e\n\u003cli\u003eAfter inhibitor has been discontinued for 3-5 elimination half-lives, resume at dose taken before initiating combined P-gp and strong CYP3A inhibitor\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eStrong CYP3A4 inducers\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eAvoid coadministration\u003c\/li\u003e\n\u003cli\u003eIf unable to avoid, double current pralsetinib dose starting on Day 7 of coadministration with strong CYP3A inducer\u003c\/li\u003e\n\u003cli\u003eAfter inducer has been discontinued for at least 14 days, resume pralsetinib at dose taken before initiating strong CYP3A inducer\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRenal impairment\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eMild-to-moderate (CrCl 30-89 mL\/min): No dosage adjustment necessary\u003c\/li\u003e\n\u003cli\u003eSevere (CrCl \u0026lt;15 mL\/min): Not studied\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHepatic impairment\u003c\/h3\u003e\u003cul\u003e\u003cli\u003eMild (total bilirubin less than or equal to ULN and AST \u0026gt; ULN or total bilirubin \u0026gt; 1 to 1.5 × ULN and any AST), moderate (total bilirubin \u0026gt; 1.5 to 3 × ULN and any AST) or severe (total bilirubin \u0026gt; 3 × ULN and any AST): No dosage adjustment necessary\u003c\/li\u003e\u003c\/ul\u003e","brand":"BIGBEAR Pharma, Laos PDR","offers":[{"title":"Default Title","offer_id":44797949837355,"sku":"RL2820240816720","price":0.0,"currency_code":"AMD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0701\/3528\/3755\/files\/2024-08-1279.jpg?v=1787022138","url":"https:\/\/xomeds.com\/products\/generic-larotrectinib-lucilaro","provider":"XOMEDS","version":"1.0","type":"link"}