Borvex

Bortezomib

Monotherapy or in combination w/ pegylated liposomal doxorubicin or dexamethasone: Treatment of progressive multiple myeloma who have at least 1 prior therapy & have undergone or are unsuitable for haematopoietic stem cell transplantation in adults. In combination w/ melphalan & prednisone: Treatment of previously untreated multiple myeloma who are not eligible for high-dose chemotherapy w/ haematopoietic stem cell transplantation in adults. In combination w/ dexamethasone or w/ dexamethasone & thalidomide: Induction treatment of previously untreated multiple myeloma who are eligible for high-dose chemotherapy w/ haematopoietic stem cell transplantation in adults.

IV/SC Progressive multiple myeloma (patient who have received at least 1 prior therapy) Monotherapy 1.3 mg/m² twice wkly for 2 wk on days 1, 4, 8 & 11 in a 21-day treatment cycle. At least 72 hr should relapse between consecutive doses. Dose adjustments during treatment & re-initiation of treatment for monotherapy Re-initiate at a 25% reduced dose (1.3 mg/m² reduced to 1 mg/m²; 1 mg/m² reduced to 0.7 mg/m²) once symptoms of toxicity are resolved. Bortezomib-related neuropathic pain &/or peripheral neuropathy Individualized dosage. Combination w/ pegylated liposomal doxorubicin 30 mg/m² pegylated liposomal doxorubicin on day 4 of treatment cycle as 1-hr IV infusion after bortezomib inj. May administer up to 8 cycles if no progress & as tolerated. Combination w/ dexamethasone 20 mg oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11 & 12 of treatment cycle. Max: 4 additional cycles. Previously untreated multiple myeloma patient not eligible for haematopoietic stem cell transplantation Combination w/ melphalan & prednisone Administer for 6-wk period treatment cycle w/ melphalan & prednisone given orally on days 1, 2, 3 & 4 of the 1st wk of each bortezomib inj treatment cycle. Cycles 1-4: Administer twice wkly on days 1, 4, 8, 11, 22, 25, 29 & 32. Cycles 5-9: Administer once wkly on days 1, 8, 22 & 29. At least 72 hr should relapse between consecutive doses. Previously untreated multiple myeloma patient eligible for haematopoietic stem cell transplantation (induction therapy) Combination w/ dexamethasone 40 mg oral dexamethasone on days 1, 2, 3, 4, 8, 9, 10 & 11 treatment cycle for 4 treatment cycles. Combination w/ dexamethasone & thalidomide 40 mg oral dexamethasone on days 1, 2, 3, 4, 8, 9, 10 & 11 treatment cycle + 50 mg daily oral thalidomide on days 1-14 & may be increased to 100 mg on days 15-28 if tolerated; may further increased to 200 mg daily from cycle 2. Administer for 4 treatment cycles & 2 additional cycles in patient w/ at least partial response. Hepatic impairment (moderate or severe) 0.7 mg/m²/inj on 1st treatment cycle & subsequent escalation to 1 mg/m² or further dose reduction to 0.5 mg/m².

Hypersensitivity to bortezomib & boron. Acute diffuse infiltrative pulmonary & pericardial disease.

Should not be administered intrathecally. Constipation. Close monitoring of complete blood count including platelet counts. Herpes zoster reactivation. Discontinue use if progressive multifocal leukoencephalopathy is diagnosed. Risk of peripheral neuropathy. Seizures. Hypotension. Posterior reversible encephalopathy syndrome (PRES). Closely monitor patients w/ risk factors for or existing heart disease & patients at risk of tumour lysis syndrome. Closely monitor patients given bortezomib in combination w/ potent CYP3A4 inhibitors. Discontinue in immunocomplex-mediated reactions eg, serum-sickness-type reaction, polyarthritis w/ rash & proliferative glomerulonephritis have been reported. May affect ability to drive or operate machinery. Pregnancy & lactation.

Thrombocytopenia, neutropenia, anaemia; decreased appetite; neuropathies, peripheral sensory neuropathy, dysaesthesia, neuralgia; nausea & vomiting, diarrhea, constipation; musculoskeletal pain.

Increased AUC w/ ketoconazole, & ritonavir. Reduced efficacy w/ strong CYP3A4 inducers eg, rifampicin, carbamazepine, phenytoin, phenobarb & St. John's wort. Oral hypoglycemics.

Targeted Cancer Therapy

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

Rx