Note: This document contains side effect information about bortezomib. Some of the dosage forms listed on this page may not apply to the brand name Velcade.
Applies to bortezomib: powder for solution
Along with its needed effects, bortezomib (the active ingredient contained in Velcade) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking bortezomib:
Incidence not known
Some side effects of bortezomib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to bortezomib: injectable powder for injection, intravenous powder for injection
Very common (10% or more): Nausea (up to 64%), diarrhea (up to 51%), constipation (up to 43%), decreased appetite (up to 43%), vomiting (up to 36%), dyspepsia (up to 13%)
Frequency not reported: Ascites, dysphagia, fecal impaction, hemorrhagic gastritis, gastrointestinal hemorrhage, hematemesis, paralytic ileus, large intestinal obstruction, paralytic intestinal obstruction, small intestinal obstruction, large intestinal perforation, stomatitis, melena, gastroenteritis, hemorrhagic duodenitis, peritonitis, oral mucosal petechiae, gastroesophageal reflux, acute pancreatitis
Grade 3 gastrointestinal events were reported to have occurred in 18% of patients and Grade 4 events were reported in 1%. Gastrointestinal events were considered to be serious in 11% of patients.
Very common (10% or more): Thrombocytopenia (34%), neutropenia (27%), anemia (23%), leukopenia (20%), lymphopenia (23%)
Uncommon (0.1% to 1%): Lymphadenopathy, febrile neutropenia, pancytopenia, hemolytic anemia, thrombocytopenia purpura
Frequency not reported: Disseminated intravascular coagulation, subdural hematoma, pancytopenia, hemolytic anemia, thrombocytopenia purpura
Thrombocytopenia was characterized by a dose related decrease in platelet count during the dosing period (days 1 through 11) with a return to the baseline platelet count during the rest period (days 12 through 21) of each treatment cycle. Thrombocytopenia was grade 3 or 4 for 24% and 5% of patients, respectively.
Grade 3 or 4 neutropenia have been reported to have occurred in 9% and 3% of treated patients, respectively.
Very common (10% or more): Peripheral neuropathy (39%), paresthesia and dysesthesia (23%), headache (22%), dizziness (17%), dysgeusia (13%), anxiety (10%)
Common (1% to 10%): Peripheral sensory neuropathy, tremor
Uncommon (0.1% to 1%): Cerebrovascular accident, convulsion, syncope, disturbance in attention, increased activity, ageusia, somnolence, migraine, jerky movements, postural dizziness, sciatica, post herpetic neuralgia, cognitive disorder, mononeuropathy, paresis, restless leg syndrome, speech disorder, intracranial hemorrhage, paraplegia, subarachnoid hemorrhage
Postmarketing reports: Autonomic neuropathy, encephalopathy
Bortezomib treatment causes a peripheral neuropathy that is predominantly sensory. However, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with preexisting symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy during treatment with bortezomib. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. Patients experiencing new or worsening peripheral neuropathy may require change in the dose and schedule of bortezomib.
Following dose adjustments, improvement in or resolution of peripheral neuropathy has been reported in 51% of patients with peripheral neuropathy greater than or equal to grade 2 in the relapsed multiple myeloma study. Improvement in or resolution of peripheral neuropathy has been reported in 73% of patients who discontinued due to grade 2 neuropathy or who had greater than or equal to grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma.
Very common (10% or more): Arthralgia (26%), pain in limb (26%), bone pain (14%), myalgia (14%), muscle cramps (14%), back pain (13%)
Common (1% to 10%): Peripheral swelling, muscle weakness, musculoskeletal pain
Uncommon (0.1% to 1%): Joint stiffness, buttock pain, joint swelling, muscle spasms, muscle twitching, sensation of heaviness, muscle stiffness, swelling, pain in jaw
Most reports of hypotension (including orthostatic hypotension) were grade 1 or 2 in severity. Grade 3 hypotension was reported to have occurred in 3% and Grade 4 hypotension was reported in less than 1% of patients.
Very common (10% or more): Hypotension (13%)
Frequency not reported: Aggravated atrial fibrillation, atrial flutter, cardiac amyloidosis, cardiac arrest, congestive cardiac failure, hypertension, myocardial ischemia, myocardial infarction, pericardial effusion, pulmonary edema, angina pectoris, bradycardia, sinus arrest, complete atrioventricular block, pericarditis, Torsades de pointes, decreased left ventricular ejection fraction, ventricular tachycardia
Very common (10% or more): Dyspnea (22%), cough (20%), upper respiratory tract infection (18%), cough (17%), lower respiratory tract/lung infection (15%), nasopharyngitis (14%), pneumonia (12%)
Common (1% to 10%): Epistaxis, dyspnea on exertion, rhinorrhea, bronchitis, sinusitis
Uncommon (0.1% to 1%): Nasal congestion, wheezing, pleural effusion, hoarseness, chest wall pain, hypoxia, pulmonary congestion, rhinitis, asthma, hyperventilation, orthopnea, sinus pain, throat tightness, productive cough, respiratory alkalosis, respiratory arrest, tachypnea, pneumococcal, bronchopneumonia, pleural infection, pulmonary edema
Frequency not reported: Acute respiratory distress syndrome, acute diffuse infiltrative pulmonary disease, atelectasis, exacerbated chronic obstructive airways disease, hemoptysis, pulmonary hypertension, pulmonary alveolar hemorrhage
Very common (10% or more): Rash (18%), herpes zoster (12%)
Very rare (less than 0.01%): Erythematous plaques or nodules on the trunk, generalized morbilliform erythema with ulcerations and fever, cutaneous vasculitis, histiocytoid Sweet Syndrome
Frequency not reported: Toxic epidermal necrolysis, leukocytoclastic vasculitis, pruritus, urticaria, facial edema
Very common (10% or more): Asthenic conditions (fatigue, malaise, and weakness) (65%), pyrexia (36%), headache (28%), insomnia (27%), dizziness (excluding vertigo) (21%), dehydration (18%), anxiety (14%), fatigue (15%), dysgeusia (13%), rigors (12%)
Common (1% to 10%): Pyrexia
Frequency not reported: Impaired hearing, aspergillosis, bacteremia, herpes viral infection, listeriosis, septic shock, toxoplasmosis, oral candidiasis, tumor lysis syndrome, vertigo
Very common (10% or more): Blurred vision (11%)
Common (1% to 10%): Eye pain
Uncommon (0.1% to 1%): Dry eye, conjunctivitis, eye discharge, abnormal vision, eye hemorrhage, photophobia, eye irritation, increased lacrimation, conjunctival hyperemia, blepharitis, eye swelling
Rare (less than 0.1%): Ophthalmic herpes
Frequency not reported: Conjunctival infection, irritation, diplopia
Postmarketing reports: Optic neuropathy, blindness
Very rare (less than 0.01%): Stevens-Johnson Syndrome
Frequency not reported: Anaphylactic reaction, drug hypersensitivity, immune complex mediated hypersensitivity
Rare (less than 0.1%): Acute liver failure (in patients receiving multiple concomitant medications and with serious underlying medical conditions)
Frequency not reported: Hyperbilirubinemia, cholestasis, hepatic hemorrhage, hepatitis, portal vein thrombosis, asymptomatic increases in liver enzymes
Very common (10% or more): Anorexia (34 to 43%), dehydration (18%)
Common (1% to 10%): Hyper- or hypocalcemia, hypokalemia, decreased weight, increased blood lactate dehydrogenase
Uncommon (0.1% to 1%): Hypoglycemia, hyperkalemia, hyperuricemia, hyper or hyponatremia, hypomagnesemia, hypophosphatemia, decreased blood bicarbonate levels, increased blood alkaline phosphatase, urea, blood amylase, and C-reactive protein, increased appetite and weight, cachexia, vitamin B12 deficiency, tumor lysis syndrome
Very common (10% or more): Peripheral neuropathies (50%), insomnia (18 to 27%), neuralgia (23%), anxiety (14%)
Common (1% to 10%): Agitation, confusion, depression
Uncommon (0.1% to 1%): Delirium, restlessness, mood swings, mental status changes, sleep disorder, irritability, hallucinations, abnormal dreams
Frequency not reported: Agitation, confusion, psychotic disorder, mental status change, suicidal ideation
Very common (10% or more): Acute and chronic renal impairment, dysuria
Uncommon (0.1% to 1%): Increased blood creatinine
Frequency not reported: Renal calculus, renal colic, hematuria, proteinuria, difficulty in micturition or micturition urgency, oliguria, bilateral hydronephrosis, bladder spasm, urinary tract infection, hemorrhagic cystitis, proliferative glomerular nephritis
Uncommon (0.1% to 1%): Injection site erythema, catheter related infection, catheter related complication, post procedural pain, post procedural hemorrhage, burns
Frequency not reported: Angioedema, laryngeal edema
Uncommon (0.1% to 1%): Syndrome of Inappropriate Antidiuretic Hormone (SIADH)
Uncommon (0.1% to 1%): Testicular pain, erectile dysfunction
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Velcade (www.drugs.com/velcade.html).
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020