Bortezomib Side Effects
Some side effects of bortezomib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to bortezomib: injectable powder for injection
Get emergency medical help if you have any of these signs of an allergic reaction while taking bortezomib: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Bortezomib may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.
Also call your doctor at once if you have:
new or worsening nerve problems such as numbness, burning, pain, weakness, or tingly feeling;
a light-headed feeling, like you might pass out;
chest pain, dry cough, swelling in your hands or ankles, feeling short of breath, even with mild exertion;
severe headache, confusion, and/or seizure (convulsions);
severe constipation, bloody or tarry stools, vomit that looks like blood or coffee grounds;
fever, chills, body aches, flu symptoms, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);
red bumps, spreading skin rash, painful skin lesions on your arms, face, or neck;
fast or slow heart rate, weak pulse, lower back pain, blood in your urine, little or no urinating;
muscle weakness, tightness, or contraction, overactive reflexes; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
diarrhea, upset stomach, vomiting;
mild nausea, vomiting, upset stomach;
diarrhea, constipation, bloating;
headache, mild dizziness;
mild rash or itching; or
mild rash or itching; or
skin irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to bortezomib: injectable powder for injection
Asthenia was predominantly reported as grade 1 or 2. Asthenia was grade 3 for 16% 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 3% of patients.
General side effects including asthenic conditions (fatigue, malaise, and weakness) (64%), pyrexia (34%), headache (22%), insomnia (20%), dizziness (excluding vertigo) (17%), back pain (13%), dehydration (10%), anxiety (10%), and rigors have been reported.
Gastrointestinal side effects have been reported including nausea (55%), diarrhea (52%), constipation (42%), decreased appetite (36%), vomiting (33%), abdominal pain (15%), ascites, dyspepsia, 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, upper abdominal pain, and 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.
Hematologic side effects including thrombocytopenia (36%), anemia (29%), neutropenia (17%), leukopenia, lymphopenia, 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 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.
Nervous system side effects including peripheral neuropathy (39%), paresthesia and dysesthesia (22%), headache (22%), dizziness (17%), anxiety (10%), 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. Postmarketing reports have included progressive multifocal leukoencephalopathy (PML).
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 side effects including arthralgia (17%), pain in limb (15%), bone pain (14%), back pain (13%), myalgia (12%), muscle cramps (11%), extremity pain, and skeletal fracture have been reported.
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.
Cardiovascular side effects have been reported including edema (23%), hypotension (13%), aggravated atrial fibrillation, atrial flutter, cardiac amyloidosis, cardiac arrest, congestive cardiac failure, hypertension, 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 side effects including dyspnea (21%), cough (20%), upper respiratory tract infection (12%), nasopharyngitis (12%), pneumonia (12%), acute respiratory distress syndrome, acute diffuse infiltrative pulmonary disease, atelectasis, bronchitis, exacerbated chronic obstructive airways disease, exertional dyspnea, epistaxis, hemoptysis, hypoxia, lower respiratory tract / lung infection, lung infiltration, pleural effusion, pulmonary hypertension, pneumonitis, respiratory distress, and respiratory failure have been reported.
Dermatologic side effects including rash (18%), herpes zoster (12%), toxic epidermal necrolysis, leukocytoclastic vasculitis, pruritus, 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 side effects including dysgeusia, impaired hearing, aspergillosis, bacteremia, herpes viral infection, listeriosis, septic shock, toxoplasmosis, oral candidiasis, tumor lysis syndrome, and vertigo have been reported.
Ocular side effects including blurred vision, conjunctival infection, irritation, and diplopia have been reported. Postmarketing reports of optic neuropathy and blindness have been received.
Hypersensitivity side effects including anaphylactic reaction, drug hypersensitivity, and immune complex mediated hypersensitivity have been reported.
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 side effects including hypocalcemia, hyperuricemia, hypokalemia, hyperkalemia, hyponatremia, hypernatremia and tumor lysis syndrome have been reported.
Psychiatric side effects (35%) have been reported, including anorexia (23%), agitation, confusion, psychotic disorder, mental status change, and suicidal ideation have been reported.
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 side effects including injection site erythema, catheter related infection, and catheter related complication have been reported.
Immunologic side effects have included angioedema and laryngeal edema.
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