Concise Prescribing Info
Multiple myeloma & mantle cell lymphoma.
Dosage/Direction for Use
Relapsed multiple myeloma & mantle cell lymphoma 1.3 mg/m2/dose IV twice wkly for 2 wk (day 1, 4, 8, 11) followed by a 10-day rest period (days 12-21). For extended therapy of >8 cycles: May be administered on the standard schedule or on a maintenance schedule of once wkly for 4 wk (day 1, 8, 15, 22), followed by a 13-day rest period (days 23-35). At least 72 hours should elapse between consecutive doses. Multiple myeloma Previously untreated patients In combination w/ melphalan 9 mg/m2 & prednisone 60 mg/m2 for nine 6-wk treatment cycles. 1.3 mg/m2/dose twice wkly in cycles 1-4 (day 1, 4, 8, 11, 22, 25, 29, 32) & once wkly  in cycles 5-9 (day 1, 8, 22, 29). Patients w/ moderate to severe hepatic impairment Reduce to 0.7 mg/m2 in 1st cycle. Consider dose escalation to 1 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Hypersensitivity to bortezomib, boron or mannitol. Intrathecal administration.
Special Precautions
Monitor patients for symptoms of neuropathy (eg, burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness). History of syncope, patients receiving medications associated w/ hypotension, dehydrated patients. Acute development or exacerbation of CHF & new onset of decreased LVEF; Closely monitor patients w/ risk factors or existing heart disease. Acute diffuse infiltrative pulmonary disease (eg, pneumonitis, interstitial pneumonia, lung infiltration & acute resp distress syndrome). Monitor CBC & platelet counts prior to each dose. Patients at risk of tumor lysis syndrome. Moderate or severe hepatic impairment. Pregnancy & lactation.
Adverse Reactions
Fatigue, fever, headache, dizziness, rash, diarrhea, nausea, constipation, vomiting, anorexia, abdominal pain, decreased appetite, thrombocytopenia, neutropenia, anemia, leukopenia, peripheral neuropathy, neuralgia, weakness, dyspnea.
Drug Interactions
Increased conc w/ ketoconazole, melphalan & prednisolone. May potentiate hypotension w/ antihypertensives (eg, propranolol). May enhance the neurotoxic effect of cyclosporin. Hyperglycemia may occur w/ oral hypoglycemic agents (eg, glimepiride).
ATC Classification
L01XG01 - bortezomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
Bortero powd for inj 3.5 mg
10 mL x 1's
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