Zuellig Pharma
Concise Prescribing Info
Multiple myeloma. Mantle cell lymphoma.
Dosage/Direction for Use
Previously untreated multiple myeloma 1.3 mg/m2 administered 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. Relapsed multiple myeloma & mantle cell lymphoma 1.3 mg/m2/dose administered 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.
Special Precautions
Not for intrathecal administration. Peripheral neuropathy, to change dose schedule or route of administration to SC. Hypotension. Cardiac disorders, monitor patients w/ risk factors/existing heart disease. Hepatic events. Pulmonary disorders. Lab tests, monitor CBC frequently. Thrombocytopenia/neutropenia, monitor platelet count prior to each dose. GI adverse events. Tumour lysis syndrome. Hepatic impairment, exposure is increased, to reduce starting doses & monitor closely for toxicities. Posterior reversible encephalopathy syndrome, discontinue if develop. May affect ability to drive & use machines. Renal & hepatic impairment. Women of childbearing potential should use effective contraception during treatment. Pregnancy & lactation.
Adverse Reactions
Thrombocytopenia, anemia, neutropenia, leucopenia, lymphopenia, pancytopenia, febrile neutropenia; arrhythmias, tachycardia, atrial fibrillation, palpitations, acute development or exacerbation of cardiac failure, including CHF, pulmonary edema, cardiogenic shock, new onset of decreased left ventricular ejection fraction, atrial flutter, bradycardia; blurred vision, conjunctival infection & irritation; constipation, diarrhea, nausea, vomiting, GI & abdominal pain, dyspepsia, pharyngolaryngeal pain, gastroesophageal reflux, eructation, abdominal distension, stomatitis & mouth ulceration, dysphagia, GI hemorrhage, rectal hemorrhage, tongue ulceration, retching, upper GI hemorrhage, hematemesis, oral mucosal petechiae, paralytic ileus; asthenic conditions, weakness, fatigue, lethargy, malaise, pyrexia, rigors, lower limb oedema, chest pain, inj site pain & irritation, inj site phlebitis; hyperbilirubinemia, abnormal LFT, hepatitis; drug hypersensitivity; nasopharyngitis, upper & lower resp tract & lung infections, pneumonia, herpes zoster & simplex, bronchitis, post-herpetic neuralgia, sinusitis, pharyngitis, oral candidiasis, UTI, catheter-related infection, sepsis & bacteremia, gastroenteritis; catheter-related complications; increased ALT, AST, alkaline phosphatase, GGT; decreased appetite & anorexia, dehydration, hyperglycemia, hypoglycemia, hyponatremia, tumour lysis syndrome; limb pain, myalgia, arthralgia; peripheral neuropathy; paresthesia & dysesthesia, dizziness, headache, dysgeusia, polyneuropathy, syncope, convulsions, loss of consciousness, ageusia; anxiety; renal impairment & failure, difficulty in micturition, hematuria; epistaxis, cough, dyspnea, exertional dyspnea, pleural effusion, rhinorrhoea, hemoptysis; skin rash, urticaria; hypotension, orthostatic hypotension, petechiae, cerebral hemorrhage.
Drug Interactions
Increased mean AUC w/ potent CYP3A4 inhibitor eg, ketoconazole, ritonavir. Reduced efficacy w/ CYP3A4 inducers eg, rifampicin, carbamazepine, phenytoin, phenobarb, St. John's wort.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XG01 - bortezomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
Velcade powd for inj (single-dose vial) 3.5 mg
(single-dose) 1's
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