Zuellig Pharma
Concise Prescribing Info
Multiple myeloma. Mantle cell lymphoma.
Dosage/Direction for Use
IV/SC Recommended starting dose: 1.3 mg/m2, may be administered IV at 1 mg/mL for 3-5 sec bolus inj or SC at 2.5 mg/mL. Previously untreated multiple myeloma In combination w/ oral melphalan & prednisone for 9, 6-wk treatment cycles. Cycles 1-4, Velcade twice wkly (Days 1, 4, 8, 11, 22, 25, 29 & 32). Cycles 5-9, Velcade once wkly (Days 1, 8, 22 & 29). At least 72 hr should elapse between consecutive doses of Velcade. Previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation (induction therapy) W/ dexamethasone IV/SC 1.3 mg/m2 twice wkly for 2 wk on days 1, 4, 8 & 11 in 21-day treatment cycle. Dexamethasone 40 mg orally on days 1, 2, 3, 4, 8, 9, 10 & 11. 4-treatment cycles are administered. W/ dexamethasone & thalidomide IV/SC 1.3 mg/m2 twice wkly for 2 wk on days 1, 4, 8 & 11 in 28-day treatment cycle. Dexamethasone 40 mg orally on days 1, 2, 3, 4, 8, 9, 10 & 11. Thalidomide 50 mg daily orally on days 1-14 & if tolerated, increase dose to 100 mg on days 15-28, thereafter may be further increased to 200 mg daily from cycle 2. 4-treatment cycles are administered. Previously untreated mantle cell lymphoma 1.3mg/m2 IV in combination w/ IV rituximab, cyclophosphamide, doxorubicin & oral prednisone for 6 3-wk treatment cycles. Velcade is administered 1st followed by rituximab. Velcade is administered twice wkly for 2 wk (days 1, 4, 8 & 11) followed by 10-day rest period on Days 12-21. Dose modification might be required if hematological toxicity &/or peripheral neuropathy occurs.
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, fluid & electrolyte replacement should be administered to prevent dehydration, advise patient regarding appropriate measures to avoid dehydration. Tumour lysis syndrome, monitor closely. 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. Avoid use during 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; hearing impairment; 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 & 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, neuralgia, chest pain, inj site pain & irritation, inj site phlebitis; hyperbilirubinemia, abnormal LFTs, 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, hyper- & 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/postural hypotension, petechiae, cerebral hemorrhage.
Drug Interactions
Increased mean AUC w/ potent CYP3A4 inhibitors eg, ketoconazole, ritonavir. Reduced mean AUC w/ potent CYP3A4 inducers eg, rifampicin & other potent CYP3A4 inducers eg, carbamazepine, phenytoin, phenobarb, St. John's wort. Close monitoring of blood glucose levels w/ oral antidiabetic agents & dose adjustments of antidiabetics. Concomitant use w/ medications associated w/ peripheral neuropathy (eg, amiodarone, antivirals, INH, nitrofurantoin or statins) or w/ decreased BP.
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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