Dr. Reddy's


Zuellig Pharma


Dr. Reddy's
Concise Prescribing Info
Mantle cell lymphoma & relapse multiple myeloma in patients who have received at least one prior therapy. In combination w/ melphalan & prednisone for treatment of previously untreated multiple myeloma. In combination w/ dexamethasone for induction treatment of patients w/ newly diagnosed multiple myeloma who are to undergo autologous stem-cell transplant.
Dosage/Direction for Use
Adult Mantle cell lymphoma &/or relapsed multiple myeloma Usual dose: 1.3 mg/m2 twice wkly for 2 wk (days 1, 4, 8, & 11) followed by 10-day rest period (days 12-21). Maintenance dose: For extended therapy of >8 cycles, may be administered on standard or maintenance schedule of once wkly (days 1, 8, 15, & 22), followed by 13-day rest period (days 23-35). At least 72 hr should elapse between consecutive doses. Grade 3 nonhematological or grade 4 hematological toxicities excluding neuropathy May be initiated at 25% reduced dose (1.3 mg/m2/dose reduced to 1 mg/m2/dose; 1 mg/m2/dose to 0.7 mg/m2/dose) once symptoms of toxicity have resolved. Previously untreated multiple myeloma In combination w/ melphalan 9 mg/m2 & prednisone 60 mg/m2 in days 1-4 for nine 6-wk treatment cycles: Bortezomib 1.3 mg/m2/dose twice wkly in cycles 1-4 (days 1, 4, 8, 11, 22, 25, 29, 32) & once wkly in cycles 5-9 (days 1, 8, 22, 29). At least 72 hr should elapse between consecutive doses of bortezomib. Induction therapy prior to stem-cell transplantation In combination w/ dexamethasone: 1.3 mg/mL by IV inj twice wkly for 2 wk (days 1, 4, 8, & 11) followed by 10-day rest period (days 12-21). Dexamethasone 40 mg was administered orally in cycles 1 & 2 on days 1-4 & 9-12, and in cycles 3 & 4 on days 1-4.
Hypersensitivity to bortezomib, boron, & mannitol. Intrathecal administration.
Special Precautions
Monitor patients for symptoms of neuropathy; preexisting symptoms &/or signs of peripheral neuropathy may worsen during treatment. History of syncope, patients receiving drugs known to be associated w/ hypotension & dehydrated patients. Closely monitor patients w/ risk factors for heart disease & those w/ existing heart disease. Consider interrupting treatment until prompt comprehensive diagnostic evaluation is conducted in the event of new or worsening cardiopulmonary symptoms. Discontinue in patients developing posterior reversible encephalopathy syndrome. GI effects. Administer fluid & electrolyte replacement to prevent dehydration. Monitor CBC frequently during treatment, & platelet counts prior to each dose of bortezomib. Patients at risk of tumor lysis syndrome ie, w/ high tumor burden prior to treatment. Hepatic effects in patients receiving multiple concomitant medications & serious underlying conditions. Women of reproductive potential should use effective contraception during therapy. Pregnancy & lactation.
Adverse Reactions
Thrombocytopenia, neutropenia, nausea, peripheral neuropathy, diarrhea, anemia, constipation, neuralgia, leukopenia, vomiting, pyrexia, fatigue, lymphopenia, anorexia, asthenia, cough, peripheral edema, insomnia, hypokalemia, pneumonia; asthenic conditions, psychiatric disorders, decreased appetite, paresthesia & dysesthesia; headache, dyspnea, rash, abdominal pain, dehydration.
Drug Interactions
Increased exposure to drugs metabolized by CPY2C19. Increased mean AUC w/ ketoconazole. Hypoglycemia & hyperglycemia may occur w/ oral antidiabetics. Increased risk of hypotension w/ hypotensives.
ATC Classification
L01XG01 - bortezomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
Myborte powd for inj 3.5 mg
((lyo)) 1's
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