Bortezomib Side Effects

Not all side effects for bortezomib may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to bortezomib: powder for solution

In addition to its needed effects, some unwanted effects may be caused by bortezomib. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking bortezomib, check with your doctor or nurse immediately:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • chills
  • confusion
  • cough
  • cough producing mucus
  • decreased urination
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • ear congestion
  • fainting
  • fever
  • headache
  • increase in heart rate
  • loss of voice
  • lower back or side pain
  • nerve pain
  • painful blisters on the trunk of the body
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid breathing
  • runny nose
  • sneezing
  • sore throat
  • stuffy nose
  • sunken eyes
  • sweating
  • swollen glands
  • thirst
  • tightness in the chest
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet
  • wrinkled skin
Less common
  • Decreased urine output
  • dilated neck veins
  • general feeling of discomfort or illness
  • increased sensitivity to pain
  • increased sensitivity to touch
  • irregular breathing
  • irregular heartbeat
  • swelling of the face, fingers, feet, or lower legs
  • thickening of bronchial secretions
  • tingling in the hands and feet
  • troubled breathing
  • unsteadiness or awkwardness
  • weight gain
Incidence not known
  • Abdominal or stomach pain and tenderness
  • agitation
  • back pain
  • blistering, peeling, or loosening of the skin
  • bloating
  • bruising
  • change in consciousness
  • coma
  • coughing or vomiting blood
  • dark urine
  • deafness
  • deep or fast breathing with dizziness, numbness to feet, hands, and around the mouth
  • diarrhea
  • drowsiness
  • fast heartbeat
  • general tiredness and weakness
  • hallucinations
  • irritability
  • itching
  • light-colored stools
  • loss of consciousness
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • pounding, slow heartbeat
  • rectal bleeding
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shaking
  • stiff neck
  • trouble sleeping
  • upper right abdominal or stomach pain
  • yellow eyes or skin

Some of the side effects that can occur with bortezomib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • bone pain
  • difficulty having a bowel movement
  • difficulty with moving
  • feeling unusually cold or shivering
  • general feeling of discomfort or illness
  • heartburn
  • indigestion
  • loss of appetite
  • loss of taste
  • mental depression
  • muscle cramps
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • pain in the limb
  • rash
  • stomach discomfort or upset, or pain
  • swelling
  • swollen joints
  • vomiting
  • weight loss

For Healthcare Professionals

Applies to bortezomib: injectable powder for injection

Gastrointestinal

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[Ref]

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.[Ref]

Hematologic

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[Ref]

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.[Ref]

Nervous system

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[Ref]

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.[Ref]

Musculoskeletal

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[Ref]

Cardiovascular

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.[Ref]

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[Ref]

Respiratory

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[Ref]

Dermatologic

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[Ref]

Other

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[Ref]

Ocular

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[Ref]

Hypersensitivity

Very rare (less than 0.01%): Stevens-Johnson Syndrome
Frequency not reported: Anaphylactic reaction, drug hypersensitivity, immune complex mediated hypersensitivity[Ref]

Hepatic

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[Ref]

Metabolic

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[Ref]

Psychiatric

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[Ref]

Renal

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[Ref]

Local

Uncommon (0.1% to 1%): Injection site erythema, catheter related infection, catheter related complication, post procedural pain, post procedural hemorrhage, burns[Ref]

Immunologic

Frequency not reported: Angioedema, laryngeal edema[Ref]

Endocrine

Uncommon (0.1% to 1%): Syndrome of Inappropriate Antidiuretic Hormone (SIADH)

Genitourinary

Uncommon (0.1% to 1%): Testicular pain, erectile dysfunction

References

1. "Product Information. Velcade (bortezomib)." Millennium Pharmaceuticals Inc, Cambridge, MA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. Garcia-Navarro X, Puig L, Fernandez-Figueras MT, Dalmau J, Roe E, Alomar A "Bortezomib-associated cutaneous vasculitis." Br J Dermatol (2007):

5. Murase JE, Wu JJ, Theate I, Cole GW, Barr RJ, Dyson SW "Bortezomib-induced histiocytoid Sweet syndrome." J Am Acad Dermatol 60 (2009): 496-7

6. Kenealy MK, Prince HM, Honemann D, Jaskiewicz AD, Herrington JD "Tumor lysis syndrome early after treatment with bortezomib for multiple myeloma." Pharmacotherapy 26 (2006): 1205-6

7. Rosinol L, Montoto S, Cibeira MT, Blade J "Bortezomib-induced severe hepatitis in multiple myeloma: a case report." Arch Intern Med 165 (2005): 464-5

8. Terpos E, Politou M, Rahemtulla A "Tumour lysis syndrome in multiple myeloma after bortezomib (VELCADE) administration." J Cancer Res Clin Oncol (2004):

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