Tevazomib

Tevazomib

bortezomib

Manufacturer:

SC Sindan

Distributor:

DKLL

Marketer:

Teva Pharma
Concise Prescribing Info
Contents
Bortezomib
Indications/Uses
Patients w/ previously untreated multiple myeloma who are unsuitable for stem cell transplantation as combination therapy. Induction treatment of patients w/ previously untreated multiple myeloma who are suitable for stem cell transplantation as combination therapy. Progressive multiple myeloma in patients who have received at least 1 prior therapy & who have already undergone or are unsuitable for stem cell transplantation. Patients w/ mantle cell lymphoma who have relapsed or were refractory to at least 1 prior therapy.
Dosage/Direction for Use
1 mg/mL for 3-5 sec as IV bolus inj or 2.5 mg/mL SC inj.
Contraindications
Hypersensitivity to bortezomib or boron. Intrathecal administration.
Special Precautions
Tumour lysis syndrome. Closely monitor patients w/ high tumor burden; risk factors for or existing heart disease; constipation. Patients w/ a history of syncope; patients receiving drugs known to be associated w/ hypotension & are dehydrated. Administer fluid & electrolyte replacement in patients w/ dehydration. Patients w/ preexisting or at the risk of peripheral neuropathy. Posterior reversible encephalopathy syndrome (PRES). Discontinue if severe autonomic neuropathy; PRES; progressive multifocal leukoencephalopathy occurs. Monitor platelet count prior to each dose; symptoms of neuropathy. Moderate or severe hepatic impairment. Acute diffuse infiltrative pulmonary disease eg, pneumonitis, interstitial pneumonia, lung infiltration & acute resp distress syndrome. Perform diagnostic evaluation if new or worsening pulmonary symptoms eg, cough, dyspnea. May be associated w/ fatigue, dizziness, syncope, orthostatic/postural hypotension or blurred vision. Males & females of child-bearing capacity should use effective contraceptive measures during treatment & for 3 mth following treatment. Childn <18 yr. Pregnancy & lactation.
Adverse Reactions
Disseminated intravascular coagulation; angina pectoris, aggravated atrial fibrillation, atrial flutter, bradycardia, sinus arrest, cardiac amyloidosis, cardiac arrest, CHF, myocardial ischemia, MI, pericarditis, pericardial effusion, pulmonary edema, ventricular tachycardia; impaired hearing; diplopia; ascites, dysphagia, fecal impaction, gastroenteritis, gastritis, hemorrhagic, GI hemorrhage, hematemesis, hemorrhagic, duodenitis, ileus paralytic, large intestinal obstruction, paralytic intestinal obstruction, small intestinal obstruction, large intestinal perforation, stomatitis, melena, acute pancreatitis; inj site erythema; cholestasis, hepatic hemorrhage, hyperbilirubinemia, portal vein thrombosis, hepatitis & liver failure; anaphylactic reaction, drug hypersensitivity, immune complex mediated hypersensitivity, acute renal failure, (proliferative glomerulonephropathy), diffuse polyarthritis & rash; aspergillosis, bacteremia, UTI, herpes viral infection, listeriosis, septic shock, toxoplasmosis, oral candidiasis; skeletal fracture, subdural hematoma; hypocalcemia, hyperuricemia, hypokalemia, hyperkalemia, hypernatremia, hyponatremia, tumour lysis syndrome; ataxia, coma, dizziness, dysarthria, dysautonomia, encephalopathy, cranial palsy, grand mal convulsion, hemorrhagic stroke, motor dysfunction, spinal cord compression, paraplegia, transient ischemic attack; agitation, confusion, mental status changes, psychotic disorder, suicidal ideation; calculus renal, bilateral hydronephrosis, bladder spasms, hematuria, hemorrhagic cystitis, urinary incontinence, urinary retention, renal failure (acute & chronic); glomerular nephritis proliferative; acute resp distress syndrome, aspiration pneumonia, atelectasis, exacerbated chronic obstructive airways disease, dysphagia, epistaxis, hemoptysis, hypoxia, lung infiltration, pleural effusion, pneumonitis, resp distress, resp failure; urticaria, face edema; CVA, DVT, peripheral embolism, pulmonary emboism, pulmonary HTN.
Drug Interactions
Efficacy may be reduced w/ strong CYP3A inducers eg, rifampicin, carbamazepine, phenytoin, phenobarb & St. John's wort. Increased mean AUC w/ potent CYP3A4 inhibitors eg, ketoconazole & ritonavir; melphalan-prednisone. Hypoglycemia & hyperglycemia may occur w/ oral hypoglycemics.
ATC Classification
L01XG01 - bortezomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Tevazomib powd for inj 3.5 mg
Packing/Price
10 mL x 1's
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