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Bortecade

Bortecade

bortezomib

Manufacturer:

Fahrenheit Synthon
Concise Prescribing Info
Contents
Bortezomib
Indications/Uses
Multiple myeloma patients who have received at least 1 prior therapy & have demonstrated disease progression on the last therapy. Patients w/ mantle cell lymphoma who have received at least 1 prior therapy.
Dosage/Direction for Use
IV 1.3 mg/m2 as 3-5 sec bolus inj twice wkly for 2 wk (days 1, 4, 8 & 11) followed by 10-day rest period (days 12-21). At least 72 hr should elapse between consecutive doses. Patient w/ confirmed complete response Recommended to receive 2 additional cycles beyond a confirmation. Responding patient w/o complete remission Recommended to receive a total of 8 cycles. Grade 3 non-hematological or 4 hematological toxicity excluding neuropathy May be reinitiated at 25% reduced dose (1.3 mg/m2 reduced to 1 mg/m2; 1 mg/m2 reduced to 0.7 mg/m2) once symptoms of toxicity have resolved. Grade 1 w/ pain or grade 2 peripheral neuropathy Reduce to 1 mg/m2. Grade 2 w/ pain or grade 3 peripheral neuropathy Reinitiate at 0.7 mg/m2 once wkly when toxicity resolves.
Contraindications
Hypersensitivity to bortezomib, boron or mannitol.
Special Precautions
Monitor patients for symptoms of neuropathy eg, burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. Patients w/ history of syncope; receiving medications associated w/ hypotension; dehydrated. Acute development or exacerbation of CHF & new onset of decreased left ventricular ejection fraction. Closely monitor patients w/ risk factors for, or existing heart disease. Reports of hepatic events eg, acute liver failure, increased liver enzymes, hyperbilirubinemia, & hepatitis; acute diffuse infiltrative pulmonary disease of unknown etiology eg, pneumonitis, interstitial pneumonia, lung infiltration, & acute resp distress syndrome. Frequently monitor CBCs throughout treatment. Platelet counts should be monitored prior to each dose due to association w/ thrombocytopenia. Reports of GI & intracerebral hemorrhage; transfusion may be considered. May cause nausea, diarrhea, constipation & vomiting; administer fluid & electrolyte replacement to prevent dehydration. Closely monitor patients w/ high tumor burden prior to treatment due to risk of tumor lysis syndrome. May cause tiredness, dizziness, fainting, or blurred vision; do not drive or operate machinery. Closely monitor for toxicities in patients w/ renal impairment (CrCl <13 mL/min) & on hemodialysis; hepatic impairment. Women of childbearing potential should use effective contraceptive measures. Avoid being pregnant & breastfeeding during treatment. Childn.
Adverse Reactions
Thrombocytopenia, neutropenia, anaemia, leucopenia, lymphopenia, pancytopenia, febrile neutropenia, disseminated intravascular coagulation; cardiac disorders; hearing impairment, bilateral deafness; blurred vision, conjunctival infection & irritation, ophth herpes; GI disorders; asthenic conditions, weakness, fatigue, pyrexia, rigors, lower limb edema, lethargy, malaise, neuralgia, chest pain, inj site pain & irritation, inj site phlebitis; hyperbilirubinemia, abnormal LFTs, hepatitis; drug hypersensitivity; infections & infestations; catheter-related complication; increased ALT, AST, alkaline phosphatase, GGT; decreased appetite & anorexia, dehydration, hyperglycemia, hypoglycemia, hyponatremia; limb pain, myalgia, arthralgia; tumor lysis syndrome; nervous system disorders; anxiety; renal impairment & failure, difficulty in micturition, hematuria; epistaxis, cough, dyspnea, exertional dyspnea, pleural effusion, rhinorrhea, hemoptysis, acute diffuse infiltrative pulmonary disease, pulmonary HTN; skin rash, urticaria; hypotension, orthostatic/postural hypotension, petechiae, cerebral hemorrhage.
Drug Interactions
May inhibit the activity & increase exposure to CYP2C19 substrates. Closely monitor patients for either toxicities or reduced efficacy w/ concomitant use of CYP3A4 inhibitors/inducers. Closely monitor blood glucose levels of patients on concomitant oral antidiabetics. Caution w/ concomitant use of medications that may be associated w/ peripheral neuropathy (eg, amiodarone, antivirals, INH, nitrofurantoin, or statins), or w/ 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
Bortecade lyo powd for inj 3.5 mg
Packing/Price
1's
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