{"product_id":"ibrutily-emlutini-2","title":"ILUDX (Ibrutinib)","description":"Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.\r\n\u003ch3\u003e\u003cspan id=\"Chronic_Lymphocytic_LeukemiaSmall_Lymphocytic_Lymphoma\"\u003eChronic Lymphocytic Leukemia\/Small Lymphocytic Lymphoma\u003c\/span\u003e\u003c\/h3\u003e\r\nAlso indicated for CLL\/SLL in patients with 17p deletion\r\n\r\nMonotherapy or in combination with rituximab or obinutuzumab, or with bendamustine and rituximab (BR) combination: 420 mg PO qDay\r\n\r\nContinue until unacceptable toxicity or disease progression\r\n\u003ch3\u003e\u003cspan id=\"Mantle_Cell_Lymphoma\"\u003eMantle Cell Lymphoma\u003c\/span\u003e\u003c\/h3\u003e\r\nIndication was voluntary withdrawn in the U.S. by manufacturer on April 10, 2023\r\n\r\nThe decision was made to remove the indication after overall survival (OS) was similar when comparing ibrutinib or placebo in combination with bendamustine and rituximab for mantle cell lymphoma in the phase 3 SHINE trial\r\n\r\nFailure to meet this requirement led to the decision to remove the indication after consulting the FDA\r\n\u003ch3\u003e\u003cspan id=\"Waldenstrom_Macroglobulinemia\"\u003eWaldenström Macroglobulinemia\u003c\/span\u003e\u003c\/h3\u003e\r\nIndicated as monotherapy or in combination with rituximab\r\n\r\n420 mg PO qDay\r\n\r\nContinue until disease progression or unacceptable toxicity\r\n\u003ch3\u003e\u003cspan id=\"Marginal_Zone_Lymphoma\"\u003eMarginal Zone Lymphoma\u003c\/span\u003e\u003c\/h3\u003e\r\nIndication was voluntary withdrawn in the U.S. by manufacturer on April 10, 2023\r\n\r\nThe decision was made to remove the indication after the phase 3 SELENE trial failed to reach its primary endpoint of progression free survival (PFS) when comparing ibrutinib to placebo in combination with bendamustine and rituximab or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with previously untreated MZL\r\n\r\nFailure to meet this requirement led to the decision to remove the indication after consulting the FDA\r\n\u003ch3\u003e\u003cspan id=\"Chronic_Graft_vs_Host_Disease\"\u003eChronic Graft vs Host Disease\u003c\/span\u003e\u003c\/h3\u003e\r\nIndicated for chronic graft versus host disease (cGVHD) in adults who failed \u0026gt;1 lines of systemic therapy\r\n\r\n420 mg PO qDay\r\n\r\nContinue until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity\r\n\r\nIf therapy is no longer required, consider discontinuing therapy based on medical assessment of individual patient\r\n\u003ch3\u003e\u003cspan id=\"Dosage_Modifications\"\u003eDosage Modifications\u003c\/span\u003e\u003c\/h3\u003e\r\n\u003ch4\u003e\u003cspan id=\"Grade_2_cardiac_failure\"\u003eGrade 2 cardiac failure\u003c\/span\u003e\u003c\/h4\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eEvaluate benefit-risk before resuming treatment\u003c\/li\u003e\r\n \t\u003cli\u003e\r\n\u003ch5\u003e\u003cspan id=\"MCL_and_MZL\"\u003eMCL and MZL\u003c\/span\u003e\u003c\/h5\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eFirst occurrence: Restart at 420 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003eSecond occurrence: Restart at 280 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003eThird occurrence: Discontinue therapy\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n \t\u003cli\u003e\r\n\u003ch5\u003e\u003cspan id=\"CLLSLL_WM_and_cGVHD\"\u003eCLL\/SLL, WM, and cGVHD\u003c\/span\u003e\u003c\/h5\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eFirst occurrence: Restart at 280 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003eSecond occurrence: Restart at 140 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003eThird occurrence: Discontinue therapy\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003ch4\u003e\u003cspan id=\"Grade_3_cardiac_arrhythmias\"\u003eGrade 3 cardiac arrhythmias\u003c\/span\u003e\u003c\/h4\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003e\r\n\u003ch5\u003e\u003cspan id=\"MCL_and_MZL1\"\u003eMCL and MZL\u003c\/span\u003e\u003c\/h5\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eFirst occurrence: Restart at 420 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003eSecond occurrence: Discontinue therapy\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n \t\u003cli\u003e\r\n\u003ch5\u003e\u003cspan id=\"CLLSLL_WM_and_cGVHD1\"\u003eCLL\/SLL, WM, and cGVHD\u003c\/span\u003e\u003c\/h5\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eFirst occurrence: Restart at 280 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003eSecond occurrence: Discontinue therapy\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003ch4\u003e\u003cspan id=\"Grade_3_cardiac_failure_or_Grade_4_cardiac_arrhythmias\"\u003eGrade ≥3 cardiac failure or Grade 4 cardiac arrhythmias\u003c\/span\u003e\u003c\/h4\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eFirst occurrence: Discontinue therapy\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003ch4\u003e\u003cspan id=\"Nonhematological_and_hematologic_toxicities\"\u003eNonhematological and hematologic toxicities\u003c\/span\u003e\u003c\/h4\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eOther Grade 3 or 4 nonhematological toxicities\u003c\/li\u003e\r\n \t\u003cli\u003eGrade 3 or 4 neutropenia with infection or fever\u003c\/li\u003e\r\n \t\u003cli\u003eGrade 4 hematological toxicities\u003c\/li\u003e\r\n \t\u003cli\u003e\r\n\u003ch5\u003e\u003cspan id=\"MCL_and_MZL2\"\u003eMCL and MZL\u003c\/span\u003e\u003c\/h5\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eFirst occurrence: Restart at 420 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003eSecond occurrence: Restart at 280 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003eThird occurrence: Discontinue therapy\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n \t\u003cli\u003e\r\n\u003ch5\u003e\u003cspan id=\"CLLSLL_WM_and_cGVHD2\"\u003eCLL\/SLL, WM, and cGVHD\u003c\/span\u003e\u003c\/h5\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eFirst occurrence: Restart at 280 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003eSecond occurrence: Restart at 140 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003eThird occurrence: Discontinue therapy\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003ch4\u003e\u003cspan id=\"Coadministration_with_CYP3A_inhibitors\"\u003eCoadministration with CYP3A inhibitors\u003c\/span\u003e\u003c\/h4\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eModerate CYP3A4 inhibitor: Reduce ibrutinib to 420 mg qDay; modify dose as recommended\u003c\/li\u003e\r\n \t\u003cli\u003e\r\n\u003ch5\u003e\u003cspan id=\"Reduce_ibrutinib_dose_to_280_mg_qDay_when_coadministered_with_the_following\"\u003eReduce ibrutinib dose to 280 mg qDay when coadministered with the following\u003c\/span\u003e\u003c\/h5\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eVoriconazole 200 mg BID\u003c\/li\u003e\r\n \t\u003cli\u003ePosaconazole suspension 100 mg qDay, 100 mg BID, or 200 mg BID\u003c\/li\u003e\r\n \t\u003cli\u003eModify dose as recommended\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n \t\u003cli\u003e\r\n\u003ch5\u003e\u003cspan id=\"Reduce_ibrutinib_dose_to_140_mg_qDay_when_coadministered_with_the_following\"\u003eReduce ibrutinib dose to 140 mg qDay when coadministered with the following\u003c\/span\u003e\u003c\/h5\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003ePosaconazole suspension 200 mg TID or 400 mg BID\u003c\/li\u003e\r\n \t\u003cli\u003ePosaconazole IV injection 300 mg qDay\u003c\/li\u003e\r\n \t\u003cli\u003ePosaconazole delayed-release tablets 300 mg qDay\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n \t\u003cli\u003e\r\n\u003ch5\u003e\u003cspan id=\"Avoid_coadministration\"\u003eAvoid coadministration\u003c\/span\u003e\u003c\/h5\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eOther strong CYP3A inhibitors (boceprevir, clarithromycin, cobicistat conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and [ombitasvir and\/or dasabuvir], ritonavir, saquinavir and ritonavir, tipranavir and ritonavir, and troleandomycin)\u003c\/li\u003e\r\n \t\u003cli\u003eIf these inhibitors will be used short term (eg, anti-infectives for \u0026lt;7 days), interrupt ibrutinib\u003c\/li\u003e\r\n \t\u003cli\u003eAfter discontinuation of a CYP3A inhibitor, resume previous dose of ibrutinib\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003ch4\u003e\u003cspan id=\"Hepatic_impairment\"\u003eHepatic impairment\u003c\/span\u003e\u003c\/h4\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003eModify dose based on following ULN unless of non-hepatic origin or due to Gilbert’s syndrome\u003c\/li\u003e\r\n \t\u003cli\u003e\r\n\u003ch5\u003e\u003cspan id=\"Total_bilirubin_TB_level_15_to_3x_ULN\"\u003eTotal bilirubin (TB) level \u0026gt;1.5 to 3x ULN\u003c\/span\u003e\u003c\/h5\u003e\r\n\u003cul\u003e\r\n \t\u003cli\u003e≥1 to \u0026lt;12 years: Reduce to 80 mg\/m\u003csup\u003e2\u003c\/sup\u003e PO qDay\u003c\/li\u003e\r\n \t\u003cli\u003e≥12 years: Reduce to 140 mg PO qDay\u003c\/li\u003e\r\n \t\u003cli\u003eTB \u0026gt;3x ULN: Avoid use\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003ch4\u003e\u003cspan id=\"Renal_impairment\"\u003eRenal impairment\u003c\/span\u003e\u003c\/h4\u003e\r\nMild-to-moderate (eCrCl ≥25 mL\/min): No dosage adjustment necessary\r\n\r\nSevere (eCrCl \u0026lt;25 mL\/min) or patients on dialysis: Not studied","brand":"BIGBEAR Pharma, Laos PDR","offers":[{"title":"Default Title","offer_id":44797946462251,"sku":"RL1420230901310","price":0.0,"currency_code":"AMD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0701\/3528\/3755\/files\/2023-08-2823.jpg?v=1787022074","url":"https:\/\/xomeds.com\/products\/ibrutily-emlutini-2","provider":"XOMEDS","version":"1.0","type":"link"}