Bortezomib Side Effects

Brand Names: Velcade

Please note - some side effects for Bortezomib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Bortezomib - for the Consumer

Bortezomib

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bortezomib:

Back, bone, or joint pain; constipation; diarrhea; dizziness; headache; lightheadedness; loss of appetite; mild muscle pain or aches; nausea; stomach pain or upset; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; blurred vision, vision loss, or other vision changes; burning, numbness, pain, or tingling in the hands or feet; change in the amount of urine produced; chest pain; confusion; dark urine; dehydration; fainting; fast or irregular heartbeat; mental or mood changes (including thoughts of suicide); one-sided weakness; seizures; severe or persistent diarrhea, vomiting, constipation, or stomach pain; severe or persistent headache or dizziness; severe or persistent muscle pain, cramping, or weakness; severe or persistent tiredness or weakness; shortness of breath; signs of an infection (chills, cough, fever, persistent sore throat); sluggishness; slurred speech; sudden weight gain; swelling or pain in the ankles, feet, or legs; unusual bruising or bleeding; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

Asthenia was predominantly reported as grade 1 or 2. Asthenia was grade 3 for 18% of patients. The first onset of fatigue was most frequently reported during the first and second cycles of therapy.

Pyrexia (greater than 38%C) was grade 3 in 4% of patients.

General side effects including asthenic conditions (fatigue, malaise, and weakness) (65%), pyrexia (36%), headache (28%), insomnia (27%), dizziness (excluding vertigo) (21%), dehydration (18%), anxiety (14%), back pain (14%), abdominal pain (13%), and rigors (12%) have been reported.

Gastrointestinal

Gastrointestinal side effects have been reported including nausea (up to 64%), diarrhea (up to 51%), constipation (up to 43%), decreased appetite (43%), vomiting (up to 36%), abdominal pain (14%), dyspepsia (up to 13%), upper abdominal pain (12%), 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, and acute pancreatitis.

Grade 3 or 4 gastrointestinal events were reported to have occurred in 21% of patients and were considered to be serious in 13% of patients.

Hematologic

Hematologic side effects including thrombocytopenia (up to 52%), neutropenia (up to 49%), anemia (up to 43%), leukopenia (33%), lymphopenia (24%), disseminated intravascular coagulation, and subdural hematoma have also been reported.

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 27% and 3% of patients, respectively.

Grade 3 or 4 neutropenia have been reported to have occurred in 13% and 3% of treated patients, respectively.

Nervous system

Nervous system side effects including peripheral neuropathy (up to 47%), neuralgia (36%), paresthesia and dysesthesia (23%), dizziness (up to 16%), headache (14%), ataxia, paralysis, postherpetic neuralgia, coma, dysarthria, dysautonomia, cranial palsy, grand mal convulsion, hemorrhagic stroke, motor dysfunction, spinal cord compression, neuralgia, encephalopathy, paraplegia, cerebral hemorrhage, reversible posterior leukoencephalopathy syndrome, and transient ischemic attack have been reported.

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.

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 26%), pain in limb (26%), back pain (17%), extremity pain (14%), myalgia (14%), muscle cramps (14%), bone pain (up to 14%), and skeletal fracture have been reported.

Cardiovascular

Most reports of hypotension (including orthostatic hypotension) were grade 1 or 2 in severity. Grade 3 hypotension was reported to have occurred in 4% of patients. Grade 4 hypotension was not reported.

Cardiovascular side effects have been reported including edema (25%), hypertension (13%), hypotension (12%), aggravated atrial fibrillation, atrial flutter, cardiac amyloidosis, cardiac arrest, congestive cardiac failure, myocardial ischemia, myocardial infarction, pericardial effusion, pulmonary edema, cerebrovascular accident, deep vein thrombosis, peripheral embolism, pulmonary embolism, angina pectoris, bradycardia, sinus arrest, complete atrioventricular block, pericarditis, Torsades de pointes, decreased left ventricular ejection fraction, and ventricular tachycardia.

Respiratory

Respiratory side effects including dyspnea (22%), cough (up to 21%), upper respiratory tract infection (18%), lower respiratory tract / lung infection (15%), dyspnea (15%), bronchitis (13%), nasopharyngitis (11%), pneumonia (10%), acute respiratory distress syndrome, acute diffuse infiltrative pulmonary disease, atelectasis, exacerbated chronic obstructive airways disease, dysphagia, exertional dyspnea, epistaxis, hemoptysis, hypoxia, lung infiltration, pleural effusion, pulmonary hypertension, pneumonitis, respiratory distress, and respiratory failure have been reported.

Dermatologic

Dermatologic side effects including rash (up to 21%), herpes zoster (11%), pruritus (up to 11%), toxic epidermal necrolysis, leukocytoclastic vasculitis, urticaria, and facial edema have been reported. One observational analysis of 47 patients treated with bortezomib in three prospective clinical trials reported five patients with sharply demarcated erythematous plaques or nodules on the trunk and one patient with generalized morbilliform erythema with ulcerations and fever. A case of cutaneous vasculitis and a case of histiocytoid Sweet syndrome have also been reported.

Other

Other side effects including dysgeusia (13%), impaired hearing, aspergillosis, bacteremia, herpes viral infection, listeriosis, septic shock, toxoplasmosis, oral candidiasis, tumor lysis syndrome, and vertigo have been reported.

Ocular

Ocular side effects including blurred vision (11%), conjunctival infection, irritation, and diplopia have been reported. Postmarketing reports of optic neuropathy and blindness have been received.

Hypersensitivity

Hypersensitivity side effects including anaphylactic reaction, drug hypersensitivity, and immune complex mediated hypersensitivity have been reported.

Hepatic

Hepatic side effects including hyperbilirubinemia, cholestasis, hepatic hemorrhage, hepatitis, portal vein thrombosis, and asymptomatic increases in liver enzymes have been reported. Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.

Metabolic

Metabolic side effects including hypocalcemia, hyperuricemia, hypokalemia, hyperkalemia, hyponatremia, hypernatremia and tumor lysis syndrome have been reported.

Psychiatric

Psychiatric side effects (35%) have been reported, including anorexia (23%), agitation, confusion, psychotic disorder, mental status change, and suicidal ideation have been reported.

Renal

Renal side effects including renal calculus, bilateral hydronephrosis, bladder spasm, hematuria, urinary incontinence, urinary retention, acute and chronic renal failure, urinary tract infection, hemorrhagic cystitis, and proliferative glomerular nephritis have been reported.

Local

Local side effects including injection site erythema, catheter related infection, and catheter related complication have been reported.

Immunologic

Immunologic side effects have included angioedema and laryngeal edema.

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