Mibzo

Bortezomib

Multiple myeloma; mantle cell lymphoma (MCL).

IV/SC Progressive multiple myeloma Patient who received at least 1 prior therapy Monotherapy: 1.3 mg/m² IV twice wkly for 2 wk on days 1, 4, 8, & 11 in 21-day treatment cycle for 2 cycles following confirmation of complete response. Patient who do not achieve complete remission Total of 8 cycles. At least 72 hr should elapse between consecutive doses. Combination w/ pegylated lipos doxorubicin: 1.3 mg/m² IV twice wkly for 2 wk on days 1, 4, 8, & 11 in 21-day treatment cycle. At least 72 hr should elapse between consecutive doses. Administer 30 mg/m² pegylated lipos doxorubicin as 1 hr IV infusion on day 4 of bortezomib treatment cycle after bortezomib inj. Combination w/ dexamethasone: 1.3 mg/m² IV twice wkly for 2 wk on days 1, 4, 8, & 11 in 21-day treatment cycle. At least 72 hr should elapse between consecutive doses. Administer 20 mg dexamethasone orally on days 1, 2, 4, 5, 8, 9, 11, & 12 of bortezomib treatment cycle. Previously untreated multiple myeloma Patient not eligible for haematopoietic stem cell transplantation Combination therapy w/ melphalan & prednisone (6-wk period treatment cycle): Cycles 1-4: Twice wkly on days 1, 4, 8, 11, 22, 25, 29 & 32. Cycles 5-9: Once wkly on days 1, 8, 22 & 29. Patient eligible for haematopoietic stem cell transplantation (induction therapy) Combination therapy w/ dexamethasone (for 4 treatment cycles): 1.3 mg/m² IV twice wkly for 2 wk on days 1, 4, 8, & 11 in 21-day treatment cycle. At least 72 hr should elapse between consecutive doses. Administer 40 mg dexamethasone orally on days 1, 2, 3, 4, 8, 9, 10, & 11 of bortezomib treatment cycle. Combination therapy w/ dexamethasone & thalidomide: 1.3 mg/m² IV twice wkly for 2 wk on days 1, 4, 8, & 11 in 28-day treatment cycle. At least 72 hr should elapse between consecutive doses. Administer 40 mg dexamethasone orally on days 1, 2, 3, 4, 8, 9, 10, & 11 of bortezomib treatment cycle, & 50 mg thalidomide orally daily on days 1-14 & may be increased to 100 mg on days 15-28 if tolerated, & may be further increased to 200 mg daily from cycle 2. Administer 4 treatment cycles of this combination, & 2 additional cycles in patients w/ at least partial response. Previously untreated MCL Combination therapy w/ rituximab, cyclophosphamide, doxorubicin & prednisone: 1.3 mg/m² IV twice wkly for 2 wk on days 1, 4, 8, & 11 followed by 10-day rest period on days 12-21. Administer on day 1 of each bortezomib treatment cycle as IV infusion: 375 mg/m² rituximab, 750 mg/m² cyclophosphamide, & 50 mg/m² doxorubicin. Administer 100 mg/m² prednisone orally on days 1, 2, 3, 4 & 5 of each bortezomib treatment cycle.

Hypersensitivity to bortezomib or mannitol. Intrathecal administration.

Interrupt therapy in cases of hepatic toxicity; for severe symptoms of GI toxicity. Discontinue treatment in patients developing posterior reversible encephalopathy syndrome. Monitor patients for symptoms of neuropathy eg, burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness; at risk of tumor lysis syndrome w/ high tumor burden prior to treatment. Closely monitor patients w/ risk factors for, or existing heart disease. Severe sensory & motor peripheral neuropathy. Hypotension; acute development or exacerbation of CHF & new onset of decreased left ventricular ejection fraction; QT-interval prolongation. Acute liver failure; hepatitis, increases in liver enzymes, & hyperbilirubinemia. Acute resp distress syndrome & acute diffuse infiltrative pulmonary disease of unknown etiology eg, pneumonitis, interstitial pneumonia, lung infiltration. Thrombocytopenia, neutropenia. Nausea, diarrhea, constipation, & vomiting sometimes requiring use of antiemetic & antidiarrheal medications; ileus. Patients w/ pre-existing symptoms (numbness, pain or burning feeling in the feet or hands) &/or signs of peripheral neuropathy; experiencing new or worsening peripheral neuropathy; w/ history of syncope, those receiving medications associated w/ hypotension, & are dehydrated; w/ no risk factors for decreased left ventricular ejection fraction. Monitor CBC frequently during treatment. Measure platelet counts prior to each dose. Administer fluid & electrolyte replacement to prevent dehydration. Moderate (bilirubin ≥1.5-3x ULN) & severe (bilirubin >3x ULN) hepatic impairment.

Nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, & anorexia.

Increased mean AUC w/ ketoconazole. Reduced mean AUC w/ rifampicin. Reduced efficacy w/ strong CYP3A4 inducers eg, rifampicin, carbamazepine, phenytoin, phenobarb & St. John's Wort. Concomitant use w/ oral antidiabetic agents.

Targeted Cancer Therapy

L01XG01 - bortezomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.

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