{"product_id":"generic-selpercatinib-sepadx","title":"SEPADX (Selpercatinib)","description":"\u003cp\u003eThe targeted drug selpercatinib  has been a treatment option for some people with lung cancer or thyroid cancer whose tumors contain specific changes in a gene called \u003cem\u003eRET\u003c\/em\u003e.\u003c\/p\u003e\u003ch3\u003eNon-small Cell Lung Cancer\u003c\/h3\u003e\u003cp\u003eIndicated for metastatic RET fusion-positive non-small cell lung cancer (NSCLC)\u003c\/p\u003e\u003cp\u003e\u0026lt;50 kg: 120 mg PO BID\u003c\/p\u003e\u003cp\u003e≥50 kg: 160 mg PO BID\u003c\/p\u003e\u003cp\u003eContinue until disease progression or unacceptable toxicity\u003c\/p\u003e\u003ch3\u003eMedullary Thyroid Cancer\u003c\/h3\u003e\u003cp\u003eIndicated for advanced or metastatic RET-mutant medullary thyroid cancer (MTC) in patients who required systemic therapy\u003c\/p\u003e\u003cp\u003e\u0026lt;50 kg: 120 mg PO BID\u003c\/p\u003e\u003cp\u003e≥50 kg: 160 mg PO BID\u003c\/p\u003e\u003cp\u003eContinue until disease progression or unacceptable toxicity\u003c\/p\u003e\u003ch3\u003eThyroid Cancer\u003c\/h3\u003e\u003cp\u003eIndicated for advanced or metastatic RET fusion-positive thyroid cancer in patients who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)\u003c\/p\u003e\u003cp\u003e\u0026lt;50 kg: 120 mg PO BID\u003c\/p\u003e\u003cp\u003e≥50 kg: 160 mg PO BID\u003c\/p\u003e\u003cp\u003eContinue until disease progression or unacceptable toxicity\u003c\/p\u003e\u003ch3\u003eOther RET Fusion-Positive Solid Tumors\u003c\/h3\u003e\u003cp\u003eIndicated for locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options\u003c\/p\u003e\u003cp\u003e\u0026lt;50 kg: 120 mg PO BID\u003c\/p\u003e\u003cp\u003e≥50 kg: 160 mg PO BID\u003c\/p\u003e\u003cp\u003eContinue until disease progression or unacceptable toxicity\u003c\/p\u003e\u003ch3\u003eDosage Modifications\u003c\/h3\u003e\u003ch4\u003eDose reduction recommendations\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eWeight \u0026lt;50 kg\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eFirst reduction: 80 mg BID\u003c\/li\u003e\n\u003cli\u003eSecond reduction: 40 mg BID\u003c\/li\u003e\n\u003cli\u003eThird reduction: 40 mg qDay\u003c\/li\u003e\n\u003cli\u003ePermanently discontinue if unable to tolerate third dose reduction\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eWeight ≥50 kg\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eFirst reduction: 120 mg BID\u003c\/li\u003e\n\u003cli\u003eSecond reduction: 80 mg BID\u003c\/li\u003e\n\u003cli\u003eThird reduction: 40 mg BID\u003c\/li\u003e\n\u003cli\u003ePermanently discontinue if unable to tolerate third dose reduction\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHepatotoxicity grade 3 or 4\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eWithhold dosing and monitor AST\/ALT once weekly until resolution to Grade 1 or baseline\u003c\/li\u003e\n\u003cli\u003eResume at reduced dose by 2 dose levels and monitor AST\/ALT once weekly until 4 weeks after reaching dose taken prior to the onset of Grade 3 or 4 increased AST or ALT\u003c\/li\u003e\n\u003cli\u003eIncrease dose by 1 dose level after a minimum of 2 weeks without recurrence, and then increase to dose taken before Grade 3 or 4 increased AST or ALT after minimum of 4 weeks without recurrence\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eInterstitial lung disease\/ pneumonitis\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eGrade 2: Withhold until resolution; resume at a reduced dose; discontinue for recurrent ILD\/pneumonitis\u003c\/li\u003e\n\u003cli\u003eGrade 3 or 4: Discontinue for confirmed ILD\/pneumonitis\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHypothyroidism\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eGrade 3 or 4: Withhold until resolution to Grade 1 or baseline; discontinue based on severity\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003eHypertension\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eGrade 3: Withhold dosing for Grade 3 hypertension that persists despite optimal antihypertensive therapy; resume at reduced dose when hypertension controlled\u003c\/li\u003e\n\u003cli\u003eGrade 4: Discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eQT prolongation\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eGrade 3: Withhold dosing until recovery to baseline or Grade ≤1; resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eGrade 4: Discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHemorrhagic events grade 3 or 4\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eWithhold dosing 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\u003ch4\u003eHypersensitivity reactions all grades\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eWithhold dosing until resolution; initiate corticosteroids\u003c\/li\u003e\n\u003cli\u003eResume at reduced dose by 3 dose levels while continuing corticosteroids\u003c\/li\u003e\n\u003cli\u003eIncrease dose by 1 dose level each week until the dose taken prior to hypersensitivity event is reached, then taper corticosteroids\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eOther adverse effects grade 3 or 4\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eWithhold dosing until recovery to baseline or Grade ≤1\u003c\/li\u003e\n\u003cli\u003eResume at reduced dose\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eCoadministration with CYP3A inhibitors\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eAvoid coadministration; if unable to avoid, reduce selpercatinib dose\u003c\/li\u003e\n\u003cli\u003eAfter inhibitor has been discontinued for 3-5 elimination half-lives, resume selpercatinib at dose take prior to initiated the CYP3A inhibitor\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eModerate CYP3A inhibitor\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eIf current dose is 120 mg BID, reduce to 80 mg BID\u003c\/li\u003e\n\u003cli\u003eIf current dose is 160 mg BID, reduce to 120 mg BID\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eStrong CYP3A inhibitor\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eIf current dose is 120 mg BID, reduce to 40 mg BID\u003c\/li\u003e\n\u003cli\u003eIf current dose is 160 mg BID, reduce to 80 mg BID\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-severe (CrCl ≥15 mL\/min): No dose adjustment required\u003c\/li\u003e\n\u003cli\u003eESRD: Recommended dose not established\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHepatic impairment\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eMild or moderate\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eNo dose adjustment required\u003c\/li\u003e\n\u003cli\u003eMild defined as: TB ≤ULN with AST \u0026gt;ULN OR TB \u0026gt;1-1.5x ULN with any AST\u003c\/li\u003e\n\u003cli\u003eModerate defined as: TB \u0026gt;1.5-3x ULN with any AST\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eSevere\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eIf current dose is 120 mg or 160 mg BID, reduce to 80 mg BID\u003c\/li\u003e\n\u003cli\u003eSevere defined as: Total biliruvin (TB) \u0026gt;3-10x ULN with any AST\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eAcid-reducing agents\u003c\/h4\u003e\u003cp\u003eAvoid with PPIs, histamine-2 (H2) receptor antagonists, or locally acting antacids\u003c\/p\u003e\u003cul\u003e\u003cli\u003e\n\u003ch5\u003eIf unable to avoid\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003ePPIs: Take with food when coadministered\u003c\/li\u003e\n\u003cli\u003eH2 receptor antagonist: Take selpercatinib 2 hr before or 10 hr after an H2 antagonist\u003c\/li\u003e\n\u003cli\u003eLocally acting antacid: Take selpercatinib 2 hr before or 2 hr after antacid\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\u003c\/ul\u003e\u003ch3\u003eDosing Considerations\u003c\/h3\u003e\u003cp\u003eSelect patients for treatment based on presence of RET gene fusion (NSCLC or thyroid cancer) or specific RET gene mutation (MTC) in tumor specimens or plasma\u003c\/p\u003e","brand":"BIGBEAR Pharma, Laos PDR","offers":[{"title":"Default Title","offer_id":44797951901739,"sku":"RL2020231216786","price":0.0,"currency_code":"AMD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0701\/3528\/3755\/files\/2023-12-1547.jpg?v=1787022163","url":"https:\/\/xomeds.com\/products\/generic-selpercatinib-sepadx","provider":"XOMEDS","version":"1.0","type":"link"}