Boruzu Side Effects

Generic name: bortezomib

Note: This document provides detailed information about Boruzu.

Applies to bortezomib: powder for solution, solution Side Effects associated with bortezomib. Some dosage forms listed on this page may not apply specifically to the brand name Boruzu.

Applies to bortezomib: powder for solution, solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 7 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

Tell your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition, called peripheral neuropathy.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may cause some people to become dizzy, drowsy, tired, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause serious heart problems. Tell your doctor right away if you have chest pain or discomfort, trouble breathing, irregular heartbeat, or swelling of the feet, ankles, or legs while you are receiving this medicine.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

This medicine may increase your chance of having a brain condition, called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you start having headaches, seizures, extreme drowsiness, confusion, or problems with vision while you are receiving this medicine.

This medicine may cause nausea, vomiting, constipation, and diarrhea, so it is important to drink plenty of fluids. It may also cause stomach or bowel blockage. If you experience dizziness or lightheadedness, contact your doctor. These could be symptoms of dehydration (not enough water in your body).

Bortezomib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause a serious reaction, called tumor lysis syndrome (TLS). Call your doctor right away if you have a change in how much or how often you urinate, muscle or joint pain, stiffness or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Thrombotic microangiopathy (damage in the smallest blood vessels), including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) may occur while you are receiving this medicine. Tell your doctor right away if you have the following symptoms: dark or bloody urine, difficulty speaking, fever, increased or decreased urination, pinpoint red spots on the skin, seizures, stomach pain, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual tiredness or weakness, or yellow eyes or skin.

If you plan to have children, talk with your doctor before receiving this medicine. Some men and women receiving this medicine have become infertile (unable to have children).

If you are diabetic and you are taking an oral antidiabetic medicine, you should check your blood sugar level often and report any unusual changes to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Boruzu

Along with its needed effects, bortezomib (the active ingredient contained in Boruzu) 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:

Other side effects of Boruzu

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:

For healthcare professionals

Applies to bortezomib: injectable powder for injection, injectable solution, intravenous injection, intravenous powder for injection, intravenous solution.

Gastrointestinal adverse events

• 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 (the active ingredient contained in Boruzu) 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

• 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]

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]

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

See also:

Frequently asked questions

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Further information

Boruzu side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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