Bortezomib Kabi

Bortezomib Kabi

bortezomib

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma

Marketer:

Fresenius Kabi
Concise Prescribing Info
Contents
Bortezomib
Indications/Uses
Multiple myeloma; mantle cell lymphoma.
Dosage/Direction for Use
IV/SC 1 mg/mL conc as 3-5 sec bolus IV inj or 2.5 mg/mL conc as SC. At least 72 hr should elapse between consecutive doses. Monotherapy: Relapsed multiple myeloma & mantle cell lymphoma 1.3 mg/m2 twice wkly for 2 wk (Days 1, 4, 8 & 11) followed by 10-day rest period (Days 12-21). Extended therapy of >8 cycles: Maintenance schedule of once wkly for 4 wk (Days 1, 8, 15 & 22) followed by 13-day rest period (Days 23-35). Combination therapy: Previously untreated multiple myeloma Patients who are ineligible for stem cell transplantation Administer w/ oral melphalan 9 mg/m2 & prednisone 60 mg/m2 for nine 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). Patients who are eligible for stem cell transplantation Recommended starting dose: 1.3 mg/m2 twice wkly on Days 1, 4, 8 & 11 in combination w/ other medicinal products, followed by 10-18 day rest period for 3-6 cycles. Relapsed multiple myeloma Bortezomib as monotherapy + pegylated lipos doxorubicin 30 mg/m2 on day 4 of 3-wk regimen as 1 hr IV infusion, or dexamethasone 20 mg on the day of & day after bortezomib dose. Previously untreated mantle cell lymphoma Bortezomib as monotherapy for 6 cycles & 2 additional cycles for patient w/ response 1st documented at Cycle 6. Administer in combination w/ rituximab 375 mg/m2, cyclophosphamide 750 mg/m2 & doxorubicin 50 mg/m2 on Day 1 of each 3-wk treatment cycle as IV infusion, & prednisone 100 mg/m2 orally on Days 1-5 of each treatment cycle. Moderate (>1.5-3x ULN) or severe (>3x ULN) hepatic impairment Reduce dose to 0.7 mg/m2 in 1st treatment cycle. May increase dose to 1 mg/m2 or further reduce to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Contraindications
Hypersensitivity to bortezomib or mannitol.
Special Precautions
Not to be administered intrathecally. Withhold therapy at onset of any Grade 3 non-hematological or Grade 4 hematological toxicities excluding neuropathy; if platelet counts ≤30 x 109/L or <25,000 cells/μL, or ANC ≤0.75 x 109/L or <750 cells/μL. Discontinue treatment at Grade 4 (life-threatening consequences; urgent intervention indicated) &/or severe autonomic neuropathy; if posterior reversible encephalopathy syndrome develops. Severe motor neuropathy w/ or w/o sensory peripheral neuropathy; acute development or exacerbation of CHF &/or new onset of decreased left ventricular ejection fraction; acute diffuse infiltrative pulmonary disease; thrombocytopenia & neutropenia. Symptoms of dizziness, light headedness or fainting spells. Patients w/ history of syncope, receiving medications associated w/ hypotension & who are dehydrated. Closely monitor patients w/ risk factors for, or existing heart disease & tumor lysis syndrome. Monitor for symptoms of neuropathy eg, burning sensation, hyper-/hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. Frequently monitor CBC throughout treatment. Monitor platelet count prior to each dose. Consider transfusion & supportive care in GI & intracerebral hemorrhage. Use antiemetics & antidiarrheal medications for GI adverse events. Administer fluid & electrolyte replacement to prevent dehydration. May affect ability to drive & use machines. Acute liver failure; increase in liver enzymes, hyperbilirubinemia & hepatitis. Hepatic impairment. Women of childbearing potential should use effective contraceptive measures. Avoid being pregnant & breastfeeding during treatment.
Adverse Reactions
Thrombocytopenia, anemia, neutropenia, leucopenia, lymphopenia, pancytopenia, febrile neutropenia; arrhythmias, tachycardia, atrial fibrillation, palpitation, 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, GERD, eructation, abdominal distention, stomatitis & mouth ulceration, dysphagia, upper & lower GI, & rectal hemorrhage (including hemorrhagic diarrhea), tongue ulceration, retching, hematemesis, oral mucosal petechiae, paralytic ileus; asthenic conditions, weakness, fatigue, lethargy, malaise, pyrexia, rigors, lower limb edema, neuralgia, chest pain, inj site pain, irritation & phlebitis; hyperbilirubinemia, abnormal LFT, hepatitis; drug hypersensitivity; URTI, nasopharyngitis, lower resp tract & lung infection, pneumonia, multidermatomal or disseminated herpes zoster, herpes simplex, bronchitis, postherpetic neuralgia, sinusitis, pharyngitis, oral candidiasis, UTI, catheter-related infection, sepsis & bacteremia, gastroenteritis, pneumonia; catheter-related complication; increased ALT, AST, alkaline phosphatase & γ-glutamyl transferase; decreased appetite & anorexia, dehydration, hyper-/hypoglycemia, hyponatremia, tumor lysis syndrome, hypokalemia; limb & back pain, myalgia, arthralgia, pain in extremity; peripheral neuropathy, paresthesia & dysesthesia, dizziness excluding vertigo, headache, dysgeusia, polyneuropathy, syncope, convulsion, loss of consciousness, ageusia, peripheral sensory neuropathy, hypoesthesia; anxiety, insomnia; renal impairment & failure; difficulty in micturition, hematuria; epistaxis, cough, dyspnea, pleural effusion, rhinorrhea, hemoptysis; skin rash (pruritic, erythematous & include evidence of leukocytoclastic vasculitis), urticaria, alopecia; hypotension, orthostatic/postural hypotension, petechiae, cerebral hemorrhage, HTN.
Drug Interactions
Increased mean AUC w/ potent CYP3A4 inhibitors eg, ketoconazole, ritonavir. Decreased mean AUC w/ potent CYP3A4 inducer eg, rifampicin, carbamazepine, phenytoin, phenobarb & St. John's wort. Concomitant use w/ oral antidiabetics & medications associated w/ peripheral neuropathy (eg, amiodarone, antivirals, INH, nitrofurantoin, or statins), or 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.
Presentation/Packing
Form
Bortezomib Kabi powd for inj 3.5 mg
Packing/Price
1's
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