Retrox

Bortezomib

Multiple myeloma. Mantle cell lymphoma.

Previously untreated multiple myeloma 1.3 mg/m² as 3-5 sec IV bolus inj in combination w/ oral melphalan & prednisone for 9, 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. Previously untreated mantle cell lymphoma 1.3 mg/m² as 3-5 sec IV bolus inj in combination w/ rituximab, cyclophosphamide, doxorubicin & oral prednisone for 6, 3-wk treatment cycles. 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 as 3-5 sec bolus IV inj twice wkly for 2 wk (days 1, 4, 8 & 11) followed by 10-day rest period (days 12-21). Extended therapy of >8 cycles: As per standard schedule or 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, boron or mannitol. Acute diffuse infiltrative pulmonary & pericardial disease.

Not for intrathecal administration. Discontinue use if progressive multifocal leukoencephalopathy is diagnosed, posterior reversible encephalopathy syndrome develops & serious immunocomplex-mediated reactions occur. Haematological & GI toxicity; HZV & HBV reactivation; new or worsening peripheral neuropathy; seizures; patients w/ history of syncope receiving medicinal products associated w/ hypotension, or dehydrated due to recurrent diarrhoea or vomiting; risk factors for or existing heart disease; QT-interval prolongation; pulmonary disorders; hepatic reactions; tumour lysis syndrome. Perform HBV screening prior to initiation in patients at risk of HBV infection. Frequently monitor CBC w/ differential & platelet counts. Concomitant use w/ potent CYP3A4 inhibitors, CYP3A4 or CYP2C19 substrates, oral hypoglycemics. May affect ability to drive & use machines. Renal & hepatic impairment. Male & female patients of childbearing potential must use effective contraceptive measures during & for 3 mth following treatment. Not to be used during pregnancy & lactation.

Nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral & sensory neuropathy, 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. 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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