{"product_id":"generic-enasidenib-luciena","title":"MEKTODK (Binimetinib)","description":"\u003ch3\u003eMelanoma\u003c\/h3\u003e\u003cp\u003eIndicated in combination with encorafenib for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation\u003c\/p\u003e\u003cp\u003e45 mg PO BID in combination with encorafenib until disease progression or unacceptable toxicity\u003c\/p\u003e\u003cp\u003eSee encorafenib drug monograph for recommended dosing information\u003c\/p\u003e\u003ch3\u003eNon-Small Cell Lung Cancer\u003c\/h3\u003e\u003cp\u003eIndicated in combination with encorafenib for patients with unresectable or metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation\u003c\/p\u003e\u003cp\u003e45 mg PO BID in combination with encorafenib until disease progression or unacceptable toxicity\u003c\/p\u003e\u003cp\u003eSee encorafenib drug monograph for recommended dosing information\u003c\/p\u003e\u003ch3\u003eDosage Modifications\u003c\/h3\u003e\u003cp\u003eIf encorafenib is permanently discontinued, discontinue binimetinib\u003c\/p\u003e\u003ch4\u003eRecommended dose reductions for binimetinib for adverse reactions\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eFirst dose reduction: 30 mg PO BID\u003c\/li\u003e\n\u003cli\u003eSubsequent modifications: Permanently discontinue if unable to tolerate 30 mg\/day\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eCardiomyopathy\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eAsymptomatic, absolute decrease in left ventricular ejection fraction (LVEF) of \u0026gt;10% from baseline that is also below lower limit of normal (LLN): Withhold for up to 4 weeks, evaluate LVEF q2Weeks\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eResume at a reduced dose if the following are present\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eLVEF is at or above the LLN and\u003c\/li\u003e\n\u003cli\u003eAbsolute decrease from baseline is ≤10% and\u003c\/li\u003e\n\u003cli\u003ePatient is asymptomatic\u003c\/li\u003e\n\u003cli\u003eIf the LVEF does not recover within 4 weeks permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003eSymptomatic congestive heart failure or absolute decrease in LVEF of greater than \u0026gt;20% from baseline that is also below LLN: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eVenous thromboembolism\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eUncomplicated DVT or PE\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold drug; if improves to Grade 0-1, resume at a reduced dose\u003c\/li\u003e\n\u003cli\u003eIf no improvement, permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003eLife-threatening PE: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eSerous retinopathy\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eSymptomatic serous retinopathy\/retinal pigment epithelial detachments\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eWithhold drug for up to 10 days\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eIf improves and becomes asymptomatic, resume at same dose\u003c\/li\u003e\n\u003cli\u003eIf not improved, resume at a lower dose or permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eRetinal vein occlusion\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eAny grade: Permanently discontinue\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003eUveitis\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eGrades 1-3\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eIf Grade 1 or 2 does not respond to specific ocular therapy, or for Grade 3 uveitis, withhold for up to 6 weeks; if improved, resume at same or reduced dose\u003c\/li\u003e\n\u003cli\u003eIf not improved, permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003eGrade 4: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eInterstitial lung disease\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 2\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold for up to 4 weeks; if improved to Grade 0-1, resume at a reduced dose\u003c\/li\u003e\n\u003cli\u003eIf not resolved within 4 weeks, permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003eGrades 3 or 4: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHepatotoxicity\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eGrade 2 AST\/ALT increased\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003eMaintain binimetinib dose; if no improvement within 2 weeks, withhold dose until improved to Grade 0-1 or to pretreatment\/baseline levels and then resume at the same dose\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eRecurrent Grade 2 or first occurrence of any Grade 3 AST\/ALT increased\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold for up to 4 weeks; if improves to Grade 0-1 or to pretreatment\/baseline level, resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eIf no improvement, permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eFirst occurrence of any Grade 4 AST\/ALT increased\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003ePermanently discontinue OR\u003c\/li\u003e\n\u003cli\u003eWithhold for up to 4 weeks; if improves to Grade 0-1 or to pretreatment\/baseline level, resume at reduced dose; if no improvement, permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eRecurrent Grade 3 AST\/ALT increased\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003eConsider permanently discontinuing\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eRecurrent Grade 4 AST\/ALT increased\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003ePermanently discontinue\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eRhabdomyolysis or CPK elevations\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eGrade 4 asymptomatic CPK elevation OR any Grade CPK elevation with symptoms or with renal impairment\u003c\/li\u003e\n\u003cli\u003eWithhold dose for up to 4 weeks; if improved to Grade 0-1 resume at a reduced dose\u003c\/li\u003e\n\u003cli\u003eIf not resolved within 4 weeks, permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eDermatologic\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eGrade 2: If no improvement within 2 weeks, withhold drug until Grade 0-1; resume at same dose if first occurrence or reduce dose if recurrent\u003c\/li\u003e\n\u003cli\u003eGrade 3: Withhold until Grade 0-1; resume at same dose if first occurrence or reduce dose if recurrent\u003c\/li\u003e\n\u003cli\u003eGrade 4: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eOther adverse reactions, including hemorrhage\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eDose modification when administered with encorafenib is NOT recommended for palmarplantar erythrodysesthesia syndrome (PPES), noncutaneous RAS mutation-positive malignancies, and QTc prolongation\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eRecurrent Grade 2 or first occurrence of any Grade 3\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eWithhold for up to 4 weeks; if improves to Grade 0-1 or to pretreatment\/baseline level, resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eIf no improvement, permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eFirst occurrence of any Grade 4\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003ePermanently discontinue OR\u003c\/li\u003e\n\u003cli\u003eWithhold for up to 4 weeks; if improves to Grade 0-1 or to pretreatment\/baseline level, resume at reduced dose; if no improvement, permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eRecurrent Grade 3\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003eConsider permanently discontinuing\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eRecurrent Grade 4\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003ePermanently discontinue\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHepatic impairment\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eModerate (total bilirubin \u0026gt;1.5 to ≤3 x ULN and any AST): 30 mg PO BID\u003c\/li\u003e\n\u003cli\u003eSevere (total bilirubin \u0026gt;3 x ULN and any AST): 30 mg PO BID\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eRenal impairment\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eNo clinically important changes in binimetinib exposure were observed with severe renal impairment as compared with patients with normal renal function\u003c\/li\u003e\u003c\/ul\u003e\u003ch3\u003eDosing Considerations\u003c\/h3\u003e\u003cp\u003eLimitations of use: Not indicated for patient with wild-type BRAF melanoma\u003c\/p\u003e\u003ch4\u003ePatient selection\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eMelanoma: Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens before initiating\u003c\/li\u003e\n\u003cli\u003eNSCLC: Confirm the presence of a BRAF V600E mutation in tumor specimens before initiating\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"BIGBEAR Pharma, Laos PDR","offers":[{"title":"Default Title","offer_id":44797950525483,"sku":"RL2620240701","price":0.0,"currency_code":"AMD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0701\/3528\/3755\/files\/2024-06-2421.jpg?v=1787022154","url":"https:\/\/xomeds.com\/products\/generic-enasidenib-luciena","provider":"XOMEDS","version":"1.0","type":"link"}