Concise Prescribing Info
Multiple myeloma; mantle cell lymphoma.
Dosage/Direction for Use
IV/SC Monotherapy: Relapsed multiple myeloma & mantle cell lymphoma 1.3 mg/m2/dose for over 3-5 sec IV bolus inj twice wkly for 2 wk (days 1, 4, 8 & 11) followed by a 10-day rest period (days 12-21). Extended therapy of >8 cycles: As standard schedule. For relapsed multiple myeloma: Maintenance schedule of once wkly for 4 wk (days 1, 8, 15 & 22) followed by a 13-day rest period (days 23-35). Elapse at least 72 hr between consecutive doses. Dose modification & re-initiation of therapy: W/held treatment at the onset of any Grade 3 non-hematological or Grade 4 hematological toxicities excluding neuropathy. May be reinitiated at 25% reduced dose (1.3 mg/m2/dose reduced to 1 mg/m2/dose; 1 mg/m2/dose reduced to 0.7 mg/m2/dose) once symptoms of toxicity is resolved. Combination therapy: Previously untreated multiple myeloma Patients who are not eligible for stem cell transplantation Combination w/ melphalan & prednisolone: Administer over 3-5 sec IV bolus inj in combination w/ PO melphalan & prednisolone for nine 6-wk treatment cycles. Cycles 1-4: Administer bortezomib (1.3 mg/m2), melphalan (9 mg/m2) & prednisolone (60 mg/m2), twice wkly (days 1, 4, 8, 11, 22, 25, 29 & 32). Cycles 5-9: Administer bortezomib (1.3 mg/m2), melphalan (9 mg/m2) & prednisolone (60 mg/m2), once wkly (days 1, 8, 22 & 29) Patients who are eligible for stem cell transplantation Initially, 1.3 mg/m2 twice wkly on days 1, 4, 8 & 11, followed by rest period of 10-18 days. Administer 3-6 cycles. Elapse at least 72 hr between consecutive doses. Relapsed multiple myeloma Combination w/ pegylated liposomal-doxorubicin: Administer pegylated liposomal-doxorubicin 30 mg/m2 on day 4 of bortezomib 3-wk regimen as 1 hr IV infusion after bortezomib inj. Combination w/ dexamethasone: Administer dexamethasone PO 20 mg on the day of, & day after bortezomib administration. Previously untreated mantle cell lymphoma Combination w/ rituximab, cyclophosphamide, doxorubicin & prednisone: Administer on day 1 of each bortezomib 3-wk treatment cycle as IV infusion: Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 & doxorubicin at 50 mg/m2. Administer prednisone PO at 100 mg/m2 on days 1, 2, 3, 4 & 5 of each treatment cycle. Moderate to severe hepatic impairment Reduce to 0.7 mg/m2 in the 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.
Special Precautions
Not for intrathecal administration due to fatal results. Peripheral neuropathy; monitor for symptoms of neuropathy, eg, burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. Hypotension; patients w/ history of syncope, receiving medications known to be associated w/ hypotension, dehydrated patients. Acute development or exacerbation of CHF, &/or new onset of decreased left ventricular ejection fraction, including patients w/ few or no risk factors for decreased left ventricular ejection fraction; closely monitor patients w/ risk factors for, or existing heart disease. Hepatic events eg, rare cases of acute liver failure, increased liver enzymes, hyperbilirubinemia & hepatitis. Pulmonary disorders eg, rare cases of acute diffuse infiltrative pulmonary disease of unknown etiology eg, pneumonitis, interstitial pneumonia, lung infiltration & acute resp distress syndrome. Tumor lysis syndrome may occur; closely monitor patients at risk of tumor lysis syndrome. Thrombocytopenia & neutropenia. GI AR eg, nausea, diarrhea, constipation & vomiting; avoid dehydration. Posterior reversible encephalopathy syndrome. Frequently monitor CBC throughout treatment. May impair ability to drive or operate machinery. Moderate or severe hepatic impairment. Avoid in women of childbearing potential; or 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, excluding oral & throat, dyspepsia, pharyngolaryngeal pain, gastroesophageal reflux, eructation, abdominal distension, stomatitis & mouth ulceration, dysphagia, GI hemorrhage (upper & lower GIT), rectal hemorrhage (includes hemorrhagic diarrhea), tongue ulceration, retching, upper GI hemorrhage, hematemesis, oral mucosal petechiae, paralytic ileus; asthenic conditions, pyrexia, rigors, edema of the lower limbs, neuralgia, chest pain, inj site pain & irritation, & phlebitis; hyperbilirubinemia, abnormal liver function tests, hepatitis; drug hypersensitivity; upper resp tract infection, nasopharyngitis, lower resp tract & lung infections, pneumonia, herpes zoster (including multidermatomal or disseminated), herpes simplex, bronchitis, postherpetic neuralgia, sinusitis, pharyngitis, oral candidiasis, UTI, catheter-related infection, sepsis & bacteremia, gastroenteritis; catheter-related complication; increased ALT AST, alkaline phosphatase, γ-glutamyl transferase (GGT); decreased appetite & anorexia, dehydration, hyperglycemia, hypoglycemia, hyponatremia, tumor lysis syndrome; pain in limb, myalgia, arthralgia; peripheral neuropathy, paresthesia & dysesthesia, dizziness, excluding vertigo, 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, which can be pruritic, erythematous, & can include evidence of leukocytoclastic vasculitis, urticaria; hypotension, orthostatic/postural hypotension, petechiae, cerebral hemorrhage. Upper abdominal pain; fatigue; pain in extremity, neuralgia; peripheral sensory neuropathy; insomnia. Peripheral oedema; back pain. Alopecia; hypokalaemia; HTN. Potentially, Stevens-Johnson syndrome, toxic epidermal necrolysis; Sweet’s syndrome.
Drug Interactions
Increased mean AUC w/ potent CYP3A4 inhibitors eg, ketoconazole, ritonavir. Hypo- & hyperglycemia in concurrent use w/ oral antidiabetic agents. Drugs associated w/ peripheral neuropathy (eg, amiodarone, antivirals, INH, nitrofurantoin, statins) or w/ a decrease in 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 1 mg
10 mL x 1's;5 mL x 1's
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