Bortezomib Side Effects

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  All medications could cause unwanted effects, however, many individuals have no, or minor, unwanted effects. Seek advice from your physician if these most typical unwanted effects persist or become annoying when utilizing Bortezomib:
  Back, bone, or joint discomfort constipation diarrhea lightheadedness headache wooziness lack of appetite mild muscle discomfort or aches nausea stomach discomfort or upset fatigue sleep problems vomiting weakness.
  Seek medical assistance immediately if these SEVERE unwanted effects occur when utilizing Bortezomib:
  Severe allergic responses (rash hives itchiness breathlessness rigidity within the chest swelling from the mouth, face, lips, or tongue) black or bloody stools blurred vision, vision loss, or any other vision changes burning, numbness, discomfort, or tingling in the possession of or ft alternation in the quantity of urine chest discomfort confusion dark urine lack of fluids fainting fast or irregular heartbeat mental or mood changes (including ideas of suicide) one-on the sides weakness seizures severe or persistent diarrhea, vomiting, constipation, or stomach discomfort severe or persistent headache or lightheadedness severe or persistent muscle discomfort, cramps, or weakness severe or persistent fatigue or weakness difficulty breathing signs and symptoms of contamination (chills, cough, fever, persistent a sore throat) slurred speech sudden putting on weight swelling or discomfort within the ankles, ft, or legs unusual bruising or bleeding vomit that appears like coffee grounds yellowing of your skin or eyes.
  This isn't an entire listing of all unwanted effects that could occur. For those who have questions regarding unwanted effects, speak to your healthcare provider. Call your physician for medical health advice about unwanted effects. To report unwanted effects towards the appropriate agency, please browse the Help guide to Confirming Problems to Food and drug administration.
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  Unwanted Effects by Body - for Health care Professionals
  General
  Asthenia was mainly reported as grade one or two. Asthenia was grade 3 for 18% of patients. The very first start of fatigue was most often reported throughout the foremost and second cycles of therapy.
  Pyrexia (more than 38%C) was grade 3 in 4% of patients.
  General unwanted effects including asthenic conditions (fatigue, malaise, and weakness)(65%), pyrexia (36%), headache (28%), insomnia (27%), lightheadedness (excluding vertigo)(21%), lack of fluids (18%), anxiety (14%), back discomfort (14%), abdominal discomfort (13%), and bustle (12%) happen to be reported.
  Intestinal
  Intestinal unwanted effects happen to be reported including nausea (as much as 64%),diarrhea (as much as 51%), constipation (as much as 43%), decreased appetite (43%),vomiting (as much as 36%),abdominal discomfort (14%), dyspepsia (as much as 13%), upper abdominal discomfort (12%),ascites, dysphagia, fecal impaction, hemorrhagic gastritis, intestinal hemorrhage, hematemesis, paralytic ileus, large intestinal obstruction, paralytic intestinal obstruction, small intestinal obstruction, large intestinal perforation, stomatitis, melena, gastroenteritis, hemorrhagic duodenitis, peritonitis, dental mucosal petechiae, gastroesophageal reflux, and acute pancreatitis.
  Grade three or four intestinal occasions were reported to possess happened in 21% of patients and were regarded as serious in 13% of patients.
  Hematologic
  Hematologic unwanted effects including thrombocytopenia (as much as 52%),neutropenia (as much as 49%), anemia (as much as 43%), leukopenia (33%), lymphopenia (24%), disseminated intravascular coagulation, and subdural hematoma are also reported.
  Thrombocytopenia was indicated with a dose related reduction in platelet count throughout the dosing period (days 1 through 11) having a go back to the baseline platelet count throughout the relaxation period (days 12 through 21) of every treatment cycle. Thrombocytopenia was grade three or four for 27% and threePercent of patients, correspondingly.
  Grade three or four neutropenia happen to be reported to possess happened in 13% and threePercent of treated patients, correspondingly.
  Central nervous system
  Central nervous system unwanted effects including peripheral neuropathy (as much as 47%), neuralgia (36%), paresthesia and dysesthesia (23%), lightheadedness (as much as 16%), headache (14%), ataxia, paralysis, postherpetic neuralgia, coma, dysarthria, dysautonomia, cranial palsy, grand mal convulsion, hemorrhagic stroke, motor disorder, spinal-cord compression, neuralgia, encephalopathy, paraplegia, cerebral hemorrhage, reversible posterior leukoencephalopathy syndrome, and transient ischemic attack happen to be reported.
  Bortezomib treatment leads to a peripheral neuropathy that's mainly physical. However, cases of severe physical and motor peripheral neuropathy happen to be reported. Patients with pre-existing signs and symptoms (numbness, discomfort or perhaps a burning perspective of ft or hands) and/or signs and symptoms of peripheral neuropathy can experience worsening peripheral neuropathy throughout treatment with bortezomib. Patients ought to be supervised for signs and symptoms of neuropathy, like a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic discomfort or weakness. Patients going through new or worsening peripheral neuropathy may need alternation in the dose and schedule of bortezomib.
  Following dose changes, improvement in or resolution of peripheral neuropathy continues to be reported in 51% of patients with peripheral neuropathy more than or comparable to grade 2 within the relapsed multiple myeloma study. Improvement in or resolution of peripheral neuropathy continues to be reported in 73% of patients who stopped because of grade 2 neuropathy or who had more than or comparable to grade 3 peripheral neuropathy within the phase 2 multiple myeloma studies. The lengthy-term results of peripheral neuropathy is not analyzed in layer cell lymphoma.
  Bone and joint
  Bone and joint unwanted effects including arthralgia (as much as 26%), discomfort in limb (26%), back discomfort (17%), extremity discomfort (14%), myalgia (14%),muscle cramps (14%), bone discomfort (as much as 14%),and skeletal fracture happen to be reported.
  Cardiovascular
  Most reviews of hypotension (including orthostatic hypotension) were grade one or two in severity. Grade 3 hypotension was reported to possess happened in 4% of patients. Grade 4 hypotension wasn't reported.
  Cardiovascular unwanted effects happen to be reported including edema (25%), hypertension (13%), hypotension (12%), irritated atrial fibrillation, atrial flutter, cardiac amyloidosis, cardiac event, congestive cardiac failure, myocardial ischemia, myocardial infarction, pericardial effusion, lung edema, cerebrovascular accident, deep vein thrombosis, peripheral embolism, lung embolism, angina pectoris, bradycardia, sinus arrest, complete atrioventricular block, pericarditis, Torsades p pointes, decreased left ventricular ejection fraction, and ventricular tachycardia.
  Respiratory system
  Respiratory system unwanted effects including dyspnea (22%), cough (as much as 21%), upper respiratory system infection (18%), lower respiratory system / lung infection (15%), dyspnea (15%), bronchitis (13%), nasopharyngitis (11%), pneumonia (10%), acute respiratory system distress syndrome, acute diffuse infiltrative lung disease, atelectasis, amplified chronic obstructive airways disease, dysphagia, exertional dyspnea, epistaxis, hemoptysis, hypoxia, lung infiltration, pleural effusion, lung hypertension, pneumonitis, respiratory system distress, and respiratory system failure happen to be reported.
  Dermatologic
  Dermatologic unwanted effects including rash (as much as 21%), herpes zoster (11%), pruritus (as much as 11%), toxic skin necrolysis, leukocytoclastic vasculitis, urticaria, and facial edema happen to be reported. One observational analysis of 47 patients given bortezomib in three prospective clinical tests reported five patients with dramatically demarcated erythematous plaques or nodules around the trunk and something patient with generalized morbilliform erythema with ulcerations and fever. A situation of cutaneous vasculitis along with a situation of histiocytoid Sweet syndrome are also reported.
  Other
  Other unwanted effects including dysgeusia (13%),impaired hearing, aspergillosis, bacteremia, herpes viral infection, listeriosis, septic shock, toxoplasmosis, dental yeast infection, tumor lysis syndrome, and vertigo happen to be reported.
  Ocular
  Ocular unwanted effects including blurred vision (11%), conjunctival infection, irritation, and diplopia happen to be reported.
  Hypersensitivity
  Hypersensitivity unwanted effects including anaphylactic reaction, drug hypersensitivity, and immune complex mediated hypersensitivity happen to be reported.
  Hepatic
  Hepatic unwanted effects including hyperbilirubinemia, cholestasis, hepatic hemorrhage, hepatitis, portal vein thrombosis, and asymptomatic increases in liver enzymes happen to be reported. Rare cases of acute liver failure happen to be reported in patients receiving multiple concomitant medicines with serious underlying health conditions.
  Metabolic
  Metabolic unwanted effects including hypocalcemia, hyperuricemia, hypokalemia, hyperkalemia, hyponatremia, hypernatremia and tumor lysis syndrome happen to be reported.
  Psychological
  Psychological unwanted effects (35%) happen to be reported, including anorexia (23%), agitation, confusion, psychotic disorder, mental status change, and suicidal ideation happen to be reported.
  Kidney
  Kidney unwanted effects including kidney calculus, bilateral hydronephrosis, bladder spasm, hematuria, bladder control problems, urinary retention, acute and chronic kidney failure, uti, hemorrhagic cystitis, and proliferative glomerular nephritis happen to be reported.
  Local
  Local unwanted effects including injection site erythema, catheter related infection, and catheter related complication happen to be reported.
  Immunologic
  Immunologic unwanted effects have incorporated angioedema and laryngeal edema.

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