{"product_id":"generic-selumetinib-semedx-25","title":"SEMEDX 25 (Selumetinib)","description":"\u003cp\u003eSelumetinib is a prescription medicine that is used to treat children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cannot be completely removed by surgery. It is not known if Selumetinib is safe and effective in children under 2 years of age.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003ePEDIATRIC\u003c\/strong\u003e\u003c\/p\u003e\u003ch3\u003e\u003cspan id=\"Type_1_Neurofibromatosis\"\u003eType 1 Neurofibromatosis\u003c\/span\u003e\u003c\/h3\u003e\u003cp\u003eIndicated for neurofibromatosis type 1 (NF1) in patients aged ≥2 years who have symptomatic, inoperable plexiform neurofibromas (PN)\u003c\/p\u003e\u003cp\u003e\u0026lt;2 years or body surface area (BSA) \u0026lt;0.55 m\u003csup\u003e2\u003c\/sup\u003e: Safety and efficacy not established\u003c\/p\u003e\u003ch5\u003e\u003cspan id=\"2_years\"\u003e≥2 years\u003c\/span\u003e\u003c\/h5\u003e\u003cul\u003e\n\u003cli\u003eBSA ≥0.55 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg\/m\u003csup\u003e2\u003c\/sup\u003e PO BID (~q12hr)\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Recommended_dosage_based_on_BSA\"\u003eRecommended dosage based on BSA\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003e0.55-0.69 m\u003csup\u003e2\u003c\/sup\u003e: 20 mg PO qAM and 10 mg PO qPM\u003c\/li\u003e\n\u003cli\u003e0.7-0.89 m\u003csup\u003e2\u003c\/sup\u003e: 20 mg PO BID\u003c\/li\u003e\n\u003cli\u003e0.9-1.09 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg PO BID\u003c\/li\u003e\n\u003cli\u003e1.1-1.29 m\u003csup\u003e2\u003c\/sup\u003e: 30 mg PO BID\u003c\/li\u003e\n\u003cli\u003e1.3-1.49 m\u003csup\u003e2\u003c\/sup\u003e: 35 mg PO BID\u003c\/li\u003e\n\u003cli\u003e1.5-1.69 m\u003csup\u003e2\u003c\/sup\u003e: 40 mg PO BID\u003c\/li\u003e\n\u003cli\u003e1.7-1.89 m\u003csup\u003e2\u003c\/sup\u003e: 45 mg PO BID\u003c\/li\u003e\n\u003cli\u003e≥1.9 m\u003csup\u003e2\u003c\/sup\u003e: 50 mg PO BID\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003e\u003cspan id=\"Dosage_Modifications\"\u003eDosage Modifications\u003c\/span\u003e\u003c\/h3\u003e\u003ch4\u003e\u003cspan id=\"Dose_reductions_for_adverse_reactions_based_on_BSA\"\u003eDose reductions for adverse reactions based on BSA\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"First_dose_reduction\"\u003eFirst dose reduction\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003e0.55-0.69 m\u003csup\u003e2\u003c\/sup\u003e: 10 mg BID\u003c\/li\u003e\n\u003cli\u003e0.7-0.89 m\u003csup\u003e2\u003c\/sup\u003e: 20 mg qAM and 10 mg qPM\u003c\/li\u003e\n\u003cli\u003e0.9-1.09 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg qAM and 10 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.1-1.29 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg qAM and 20 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.3-1.49 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg BID\u003c\/li\u003e\n\u003cli\u003e1.5-1.69 m\u003csup\u003e2\u003c\/sup\u003e: 30 mg BID\u003c\/li\u003e\n\u003cli\u003e1.7-1.89 m\u003csup\u003e2\u003c\/sup\u003e: 35 mg qAM and 30 mg qPM\u003c\/li\u003e\n\u003cli\u003e≥1.9 m\u003csup\u003e2\u003c\/sup\u003e: 35 mg BID\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Second_dose_reduction\"\u003eSecond dose reduction\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003e0.55-0.69 m\u003csup\u003e2\u003c\/sup\u003e: 10 mg qDay\u003c\/li\u003e\n\u003cli\u003e0.7-1.09 m\u003csup\u003e2\u003c\/sup\u003e: 10 mg BID\u003c\/li\u003e\n\u003cli\u003e1.1-1.29 m\u003csup\u003e2\u003c\/sup\u003e: 20 mg qAM and 10 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.3-1.49 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg qAM and 10 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.5-1.89 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg qAM and 20 mg qPM\u003c\/li\u003e\n\u003cli\u003e≥1.9 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg BID\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Subsequent_dose_reductions\"\u003eSubsequent dose reductions\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003ePermanently discontinue in patients unable to tolerate selumetinib after 2 dose reductions\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Cardiomyopathy\"\u003eCardiomyopathy\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eAsymptomatic decrease in left ventricular ejection fraction (LVEF) ≥10% from baseline and lower level of normal (LLN): Withhold until resolution; resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eSymptomatic decreased LVEF OR Grade 3 or 4 decreased LVEF: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Ocular_toxicity\"\u003eOcular toxicity\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eRetinal pigment epithelial detachment (RPED): Withhold until resolution; resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eRetinal vein occlusion (RVO): Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Gastrointestinal_toxicity\"\u003eGastrointestinal toxicity\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eGrade 3 diarrhea: Withhold until improved to Grade \u0026lt;1; resume at same dose; permanently discontinue if no improvement within 3 days\u003c\/li\u003e\n\u003cli\u003eGrade 4 diarrhea OR Grade 3 or 4 colitis: Permanently discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Skin_toxicity\"\u003eSkin toxicity\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eGrade 3 or 4: Withhold until improvement; resume at reduced dose\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Increased_creatine_phosphokinase_CPK\"\u003eIncreased creatine phosphokinase (CPK)\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eGrade 4 increased CPK OR any increased CPK and myalgia: Withhold until improved to Grade \u0026lt;1; resume at reduced dose; permanently discontinue if no improvement within 3 weeks\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Other_adverse_reactions\"\u003eOther adverse reactions\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eIntolerable Grade 2 OR Grade 3: Withhold until improved to Grade \u0026lt;1; resume at reduced dose\u003c\/li\u003e\n\u003cli\u003eGrade 4: Withhold until improved to Grade \u0026lt;1; resume at reduced dose; consider discontinuation\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Dosage_modifications_for_drug_interactions\"\u003eDosage modifications for drug interactions\u003c\/span\u003e\u003c\/h4\u003e\u003ch5\u003e\u003cspan id=\"Strong_or_moderate_CYP3A4_inhibitors_or_fluconazole\"\u003eStrong or moderate CYP3A4 inhibitors or fluconazole\u003c\/span\u003e\u003c\/h5\u003e\u003cul\u003e\n\u003cli\u003eAvoid coadministration\u003c\/li\u003e\n\u003cli\u003eIf coadministration cannot be avoided, reduce selumetinib dosage based on the recommendations below\u003c\/li\u003e\n\u003cli\u003eResume selumetinib after discontinuation of the strong or moderate CYP3A4 inhibitor or fluconazole for 3 elimination half-lives\u003c\/li\u003e\n\u003cli\u003eReduce current dose by 5 mg\/m2 (eg, 25 mg\/m\u003csup\u003e2\u003c\/sup\u003e to 20 mg\/m\u003csup\u003e2\u003c\/sup\u003e OR 20 mg\/m\u003csup\u003e2\u003c\/sup\u003e to 15 mg\/m\u003csup\u003e2\u003c\/sup\u003e)\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Dosage_reduction_to_20_mgm2_based_on_BSA\"\u003eDosage reduction to 20 mg\/m2 based on BSA\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003e0.55-0.69 m\u003csup\u003e2\u003c\/sup\u003e: 10 mg BID\u003c\/li\u003e\n\u003cli\u003e0.7-0.89 m\u003csup\u003e2\u003c\/sup\u003e: 20 mg qAM and 10 mg qPM\u003c\/li\u003e\n\u003cli\u003e0.9-1.09 m\u003csup\u003e2\u003c\/sup\u003e: 20 mg BID\u003c\/li\u003e\n\u003cli\u003e1.1-1.29 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg BID\u003c\/li\u003e\n\u003cli\u003e1.3-1.49 m\u003csup\u003e2\u003c\/sup\u003e: 30 mg qAM and 25 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.5-1.69 m\u003csup\u003e2\u003c\/sup\u003e: 35 mg qAM and 30 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.7-1.89 m\u003csup\u003e2\u003c\/sup\u003e: 35 mg BID\u003c\/li\u003e\n\u003cli\u003e≥1.9 m\u003csup\u003e2\u003c\/sup\u003e: 40 mg BID\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003e\u003cspan id=\"Dosage_reduction_to_15_mgm2_based_on_BSA\"\u003eDosage reduction to 15 mg\/m2 based on BSA\u003c\/span\u003e\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003e0.55-0.69 m\u003csup\u003e2\u003c\/sup\u003e: 10 mg qDay\u003c\/li\u003e\n\u003cli\u003e0.7-0.89 m\u003csup\u003e2\u003c\/sup\u003e: 10 mg BID\u003c\/li\u003e\n\u003cli\u003e0.9-1.09 m\u003csup\u003e2\u003c\/sup\u003e: 20 mg qAM and 10 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.1-1.29 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg qAM and 10 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.3-1.49 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg qAM and 20 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.5-1.69 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg BID\u003c\/li\u003e\n\u003cli\u003e1.7-1.89 m\u003csup\u003e2\u003c\/sup\u003e: 30 mg qAM and 25 mg qPM\u003c\/li\u003e\n\u003cli\u003e≥1.9 m\u003csup\u003e2\u003c\/sup\u003e: 30 mg BID\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Renal_impairment\"\u003eRenal impairment\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\u003cli\u003eNo dosage adjustment necessary\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003e\u003cspan id=\"Hepatic_impairment\"\u003eHepatic impairment\u003c\/span\u003e\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eMild (Child-Pugh A): No dosage adjustment necessary\u003c\/li\u003e\n\u003cli\u003e\n\u003ch4\u003e\u003cspan id=\"Moderate_Child-Pugh_B_Reduce_recommended_dose_to_20_mgm2_BID\"\u003eModerate (Child-Pugh B): Reduce recommended dose to 20 mg\/m2 BID\u003c\/span\u003e\u003c\/h4\u003e\n\u003cul\u003e\n\u003cli\u003e0.55-0.69 m\u003csup\u003e2\u003c\/sup\u003e: 10 mg BID\u003c\/li\u003e\n\u003cli\u003e0.7-0.89 m\u003csup\u003e2\u003c\/sup\u003e: 20 mg qAM and 10 mg qPM\u003c\/li\u003e\n\u003cli\u003e0.9-1.09 m\u003csup\u003e2\u003c\/sup\u003e: 20 mg BID\u003c\/li\u003e\n\u003cli\u003e1.1-1.29 m\u003csup\u003e2\u003c\/sup\u003e: 25 mg BID\u003c\/li\u003e\n\u003cli\u003e1.3-1.49 m\u003csup\u003e2\u003c\/sup\u003e: 30 mg qAM and 25 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.5-1.69 m\u003csup\u003e2\u003c\/sup\u003e: 35 mg qAM and 30 mg qPM\u003c\/li\u003e\n\u003cli\u003e1.7-1.89 m\u003csup\u003e2\u003c\/sup\u003e: 35 mg BID\u003c\/li\u003e\n\u003cli\u003e≥1.9 m\u003csup\u003e2\u003c\/sup\u003e: 40 mg BID\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003eSevere (Child-Pugh C): Selumetinib unbound AUC increased 3.2-fold in subjects with severe hepatic impairment compared with normal hepatic function; no dosage recommended\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"BIGBEAR Pharma, Laos PDR","offers":[{"title":"Default Title","offer_id":44797953015851,"sku":"RL2520240415","price":0.0,"currency_code":"AMD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0701\/3528\/3755\/files\/2024-06-2423.jpg?v=1787022190","url":"https:\/\/xomeds.com\/products\/generic-selumetinib-semedx-25","provider":"XOMEDS","version":"1.0","type":"link"}