Myborte

Bortezomib

Multiple myeloma. Mantle cell lymphoma in patients who have received at least 1 prior therapy.

Previously untreated multiple myeloma 1.3 mg/m² as 3-5 sec IV bolus inj in combination w/ oral melphalan & prednisone for nine 6-wk treatment cycles. Cycles 1-4: Administer twice wkly (days 1, 4, 8, 11, 22, 25, 29 & 32). Cycles 5-9: Administer once wkly (days 1, 8, 22 & 29). At least 72 hr should elapse between consecutive doses. Patient eligible for haematopoietic stem cell transplantation (induction therapy) Combination w/ dexamethasone: 1.3 mg/m² IV inj twice wkly for 2 wk (days 1, 4, 8 & 11) in 21-day treatment cycle w/ dexamethasone PO 40 mg on days 1, 2, 3, 4, 8, 9, 10 & 11. Combination w/ dexamethasone & thalidomide: 1.3 mg/m² IV inj twice wkly for 2 wk (days 1, 4, 8 & 11) in 28-day treatment cycle w/ dexamethasone PO 40 mg on days 1, 2, 3, 4, 8, 9, 10 & 11 & thalidomide PO 50 mg daily (days 1-14), increased to 100 mg (days 15-28) if tolerated & further increased to 200 mg daily from cycle 2. Previously untreated mantle cell lymphoma 1.3 mg/m² IV in combination w/ IV rituximab, cyclophosphamide, doxorubicin & oral prednisone (VcR-CAP) for six 3-wk treatment cycles, administered 1st followed by rituximab. Administer twice wkly for 2 wk (days 1, 4, 8 & 11) followed by 10-day rest period (days 12-21). At least 72 hr should elapse between consecutive doses. Relapsed multiple myeloma & mantle cell lymphoma 1.3 mg/m²/dose twice wkly for 2 wk (days 1, 4, 8 & 11) followed by 10-day rest period (days 12-21). For extended therapy of >8 cycles: Standard schedule or for relapsed multiple myeloma, on maintenance schedule of once wkly for 4 wk (days 1, 8, 15 & 22) followed by 13-day rest period (days 23-35). At least 72 hr should elapse between consecutive doses.

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

Not to be given intrathecally. Discontinue use if progressive multifocal leukoencephalopathy, posterior reversible encephalopathy syndrome are diagnosed & potentially immunocomplex-mediated reactions occur. GI & haematological toxicity; HSV & HBV reactivation & infection; new or worsening peripheral neuropathy; risk factors for seizures; patients w/ history of syncope receiving medicinal products associated w/ hypotension, dehydration due to recurrent diarrhoea or vomiting; risk factors for or existing heart disease; QT-interval prolongation; pneumonitis, interstitial pneumonia, lung infiltration, acute resp distress syndrome; hepatic reactions; tumour lysis syndrome. Closely monitor patients w/ constipation, symptoms of neuropathy. Frequently monitor CBC w/ differential & platelet counts prior to each dose. Not recommended in concomitant use w/ strong CYP3A4 inducers. Combination w/ potent CYP3A4 inhibitors, CYP2C19 substrates, oral hypoglycemics. May affect ability to drive & use machines. Renal & hepatic impairment. Male & female patients of childbearing potential must use effective contraception during & for 3 mth after last dose. Not to be used during pregnancy. Lactation.

Nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster, myalgia.

Reduced efficacy w/ strong CYP3A4 inducers eg, rifampicin, carbamazepine, phenytoin, phenobarb, St. John's wort. Monitor blood glucose levels w/ oral antidiabetics. Concomitant use w/ potent CYP3A4 inhibitors eg, ketoconazole, ritonavir.

Targeted Cancer Therapy

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

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