{"product_id":"generic-larotrectinib-larodx-25","title":"LARODX 25 (Larotrectinib)","description":"\u003ch2\u003eLarotrectinib\u003c\/h2\u003e\u003cp\u003eLarotrectinib is a medication for the treatment of cancer.\u003csup id=\"cite_ref-Vitrakvi_AU_summary_4-0\" class=\"reference\"\u003e\u003c\/sup\u003eIt is an inhibitor of tropomyosin kinase receptors TrkA, TrkB, and TrkC.\u003csup id=\"cite_ref-pmid30069765_7-0\" class=\"reference\"\u003e\u003c\/sup\u003e \u003c\/p\u003e\u003cp\u003eLarotrectinib was initially awarded orphan drug status in 2015, for soft tissue sarcoma, and breakthrough therapy designation in 2016 for the treatment of metastatic solid tumors with NTRK fusion.Some clinical trial results were announced in 2017. On 26 November 2018, Larotrectinib was approved by the FDA.\u003c\/p\u003e\u003cp\u003eLarotrectinib was the first drug to be specifically developed and approved to treat \u003ci\u003eany\u003c\/i\u003e cancer containing certain mutations, as opposed to cancers of specific tissues (i.e., the approval is \"tissue agnostic\"). Several earlier drugs, including pembrolizumab, were eventually approved by the FDA for treatment of specific mutations independent of the type of cancer, but those drugs had been initially developed for specific cancer types.The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.\u003csup id=\"cite_ref-14\" class=\"reference\"\u003e\u003c\/sup\u003e\u003c\/p\u003e\u003ch2\u003eADULT\u003c\/h2\u003e\u003cdiv class=\"collapse-more\"\u003e\n\u003ch3\u003eDosage Forms \u0026amp; Strengths\u003c\/h3\u003e\n\u003ch4\u003ecapsule\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003e25mg\u003c\/li\u003e\n\u003cli\u003e100mg\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch4\u003eoral solution\u003c\/h4\u003e\n\u003cul\u003e\u003cli\u003e20mg\/mL\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/div\u003e\u003cdiv id=\"str-native-pl-421\" class=\"Adunit-sfp\"\u003e\u003cdiv id=\"str-native-cont-421\"\u003e \u003c\/div\u003e\u003c\/div\u003e\u003ch3\u003eSolid Tumors\u003c\/h3\u003e\u003cp\u003eIndicated for adults and pediatric 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 have no alternative treatments or have progressed following treatment\u003c\/p\u003e\u003cp\u003e100 mg PO BID\u003c\/p\u003e\u003cp\u003eContinue until disease progression or until unacceptable toxicity\u003c\/p\u003e\u003ch3\u003eDosage Modifications\u003c\/h3\u003e\u003ch4\u003eDosage modifications for adverse reactions\u003c\/h4\u003e\u003cul\u003e\u003cli\u003e\n\u003ch5\u003eBody Surface Area (BSA) ≥1 m2\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eFirst occurrence: 75 mg BID\u003c\/li\u003e\n\u003cli\u003eSecond occurrence: 50 mg BID\u003c\/li\u003e\n\u003cli\u003eThird occurrence: 100 mg qDay\u003c\/li\u003e\n\u003cli\u003eUnable to tolerate 100 mg qDay: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003eGrade ≥3 adverse reactions\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eWithhold until reaction resolves or improves to baseline or Grade ≤1\u003c\/li\u003e\n\u003cli\u003eResolved within 4 weeks: Resume at next dosage modification\u003c\/li\u003e\n\u003cli\u003eUnresolved within 4 weeks: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eStrong CYP3A4 inhibitors\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eAvoid coadministration\u003c\/li\u003e\n\u003cli\u003eIf unavoidable, reduce larotrectinib dose by 50%\u003c\/li\u003e\n\u003cli\u003eOnce strong CYP3A4 inhibitor is discontinued for 3-5 elimination half-lives, resume larotrectinib at dose taken before initiating CYP3A4 inhibitor\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eStrong CYP3A4 inducers\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eAvoid coadministration\u003c\/li\u003e\n\u003cli\u003eIf unavoidable, double larotrectinib dose\u003c\/li\u003e\n\u003cli\u003eOnce strong CYP3A4 inducer is discontinued for 3-5 elimination half-lives, resume larotrectinib at dose taken prior to initiating CYP3A4 inducer\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHepatic impairment\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eMild (Child-Pugh A): No dosage adjustment necessary\u003c\/li\u003e\n\u003cli\u003eModerate to severe (Child-Pugh B or C): Reduce starting dose by 50%\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eRenal impairment\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eMild to severe: No dosage adjustment necessary\u003c\/li\u003e\u003c\/ul\u003e\u003ch3\u003eDosing Considerations\u003c\/h3\u003e\u003cp\u003eVerify pregnancy status in females of reproductive potential before initiation\u003c\/p\u003e\u003ch4\u003ePatient selection\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eSelect patients based on presence of a NTRK gene fusion in tumor specimens\u003c\/li\u003e\u003c\/ul\u003e\u003ch2\u003ePEDIATRIC\u003c\/h2\u003e\u003cdiv class=\"collapse-more\"\u003e\n\u003ch3\u003eDosage Forms \u0026amp; Strengths\u003c\/h3\u003e\n\u003ch4\u003ecapsule\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003e25mg\u003c\/li\u003e\n\u003cli\u003e100mg\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch4\u003eoral solution\u003c\/h4\u003e\n\u003cul\u003e\u003cli\u003e20mg\/mL\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/div\u003e\u003cdiv id=\"str-native-pl-421\" class=\"Adunit-sfp\"\u003e\u003cdiv id=\"str-native-cont-421\"\u003e \u003c\/div\u003e\u003c\/div\u003e\u003ch3\u003eSolid Tumors\u003c\/h3\u003e\u003cp\u003endicated for adults and pediatric 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 have no alternative treatments or have progressed following treatment\u003c\/p\u003e\u003cp\u003eBody surface area (BSA) \u0026lt;1 m2: 100 mg\/m2 PO BID \u003ca class=\"calc_link\" data-calc=\"bsa-dosing\" data-cond=\"\" data-sec=\"Pediatric Dosing \u0026amp; Uses\" data-text=\"Body surface area (BSA) \u0026lt;1 m2: 100 mg\/m2 PO BID\"\u003e \u003c\/a\u003e\u003c\/p\u003e\u003cp\u003eBSA ≥1 m\u003csup\u003e2\u003c\/sup\u003e: 100 mg PO BID\u003c\/p\u003e\u003cp\u003eContinue until disease progression or until unacceptable toxicity\u003c\/p\u003e\u003ch3\u003eDosage Modifications\u003c\/h3\u003e\u003ch4\u003eDosage modifications for adverse reactions\u003c\/h4\u003e\u003cul\u003e\u003cli\u003e\n\u003ch5\u003eBSA \u0026lt;1 m2\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eFirst occurrence: 75 mg\/m\u003csup\u003e2\u003c\/sup\u003e BID\u003c\/li\u003e\n\u003cli\u003eSecond occurrence: 50 mg\/m\u003csup\u003e2\u003c\/sup\u003e BID\u003c\/li\u003e\n\u003cli\u003eThird occurrence: Not to exceed 25 mg\/m\u003csup\u003e2\u003c\/sup\u003e BID; remain on 25 mg\/m\u003csup\u003e2\u003c\/sup\u003e BID even if BSA becomes \u0026gt;1 m\u003csup\u003e2\u003c\/sup\u003e during treatment\u003c\/li\u003e\n\u003cli\u003eUnable to tolerate 25 mg\/m\u003csup\u003e2\u003c\/sup\u003e BID: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch5\u003eBSA ≥1 m2\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eFirst occurrence: 75 mg BID\u003c\/li\u003e\n\u003cli\u003eSecond occurrence: 50 mg BID\u003c\/li\u003e\n\u003cli\u003eThird occurrence: 100 mg qDay\u003c\/li\u003e\n\u003cli\u003eUnable to tolerate 100 mg qDay: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003eGrade ≥3 adverse reactions\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eWithhold until reaction resolves or improves to baseline or Grade ≤1\u003c\/li\u003e\n\u003cli\u003eResolved within 4 weeks: Resume at next dosage modificatio\u003c\/li\u003e\n\u003cli\u003eUnresolved within 4 weeks: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eStrong CYP3A4 inhibitors\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eAvoid coadministration\u003c\/li\u003e\n\u003cli\u003eIf unavoidable, reduce larotrectinib dose by 50%\u003c\/li\u003e\n\u003cli\u003eOnce strong CYP3A4 inhibitor is discontinued for 3-5 elimination half-lives, resume larotrectinib at dose taken before initiating CYP3A4 inhibitor\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eStrong CYP3A4 inducers\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eAvoid coadministration\u003c\/li\u003e\n\u003cli\u003eIf unavoidable, double larotrectinib dose\u003c\/li\u003e\n\u003cli\u003eOnce strong CYP3A4 inducer is discontinued for 3-5 elimination half-lives, resume larotrectinib at dose taken before initiating CYP3A4 inducer\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHepatic impairment\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eMild (Child-Pugh A): No dosage adjustment necessary\u003c\/li\u003e\n\u003cli\u003eModerate to severe (Child-Pugh B or C): Reduce starting dose by 50%\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eRenal impairment\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eMild to severe: No dosage adjustment necessary\u003c\/li\u003e\u003c\/ul\u003e\u003ch3\u003eDosing Considerations\u003c\/h3\u003e\u003cp\u003eVerify pregnancy status in females of reproductive potential before initiation\u003c\/p\u003e\u003ch4\u003ePatient selection\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eSelect patients based on presence of a NTRK gene fusion in tumor specimens\u003c\/li\u003e\u003c\/ul\u003e","brand":"BIGBEAR Pharma, Laos PDR","offers":[{"title":"Default Title","offer_id":44797952950315,"sku":"RL2620240606","price":0.0,"currency_code":"AMD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0701\/3528\/3755\/files\/2024-05-3027.jpg?v=1787022187","url":"https:\/\/xomeds.com\/products\/generic-larotrectinib-larodx-25","provider":"XOMEDS","version":"1.0","type":"link"}