Presentation
The present study analyzed cell proliferation and cell apoptosis by MTT and FITC‑Annexin V assays. [ncbi.nlm.nih.gov]
Our case presentation, we present a case of bortezomib-induced biopsy-proven AIN, which, to our knowledge, has not previously been reported. [doi.org]
Proteasomes are present in all cells and play an important role in controlling cell function, growth and also how cells interact with the other cells around them. [investor.jnj.com]
Entire Body System
- Weight Gain
gain, cough with mucus, fast heartbeats, sleep problems; or signs of tumor cell breakdown--muscle cramps, tiredness, fast or slow heart rate, fluttering in your chest, decreased urination, tingling around your mouth. [drugs.com]
gain of 5 pounds in one week (fluid retention) Easy bleeding or bruising Confusion and/or agitation Hallucinations Trouble understanding or speaking Blurry vision or changes in your eyesight Numbness or lack of strength to your arms, legs, face, or body [upmc.com]
gain, cough with mucus, fast heartbeats, sleep problems ; or signs of tumor cell breakdown -- muscle cramps, tiredness, fast or slow heart rate, fluttering in your chest, decreased urination, tingling around your mouth. [emedicinehealth.com]
- Intravenous Administration
Characterize bortezomib pharmacokinetics/pharmacodynamics in relapsed myeloma patients after single and repeat intravenous administration at two doses. [ncbi.nlm.nih.gov]
Keith Stewart Original Article First Online: 20 March 2010 Abstract Purpose Characterize bortezomib pharmacokinetics/pharmacodynamics in relapsed myeloma patients after single and repeat intravenous administration at two doses. [doi.org]
[see How Supplied/Storage and Handling] In clinical trials, local skin irritation was reported in 5% of patients, but extravasation of VELCADE was not associated with tissue damage. 2.7 Reconstitution/Preparation for Intravenous Administration Proper [globalrph.com]
"Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study". The Lancet. Oncology. 12 (5): 431–40. doi:10.1016/s1470-2045(11)70081-x. [en.wikipedia.org]
- Dentist
Tell any other doctors, dentists and pharmacists who are treating you that you are having VELCADE. If you are about to be started on any new medicines, tell your doctor, dentist or pharmacist that you are having VELCADE. [news-medical.net]
Treatment for other conditions Always tell other doctors, nurses, pharmacists or dentists that you’re having this treatment if you need treatment for anything else, including teeth problems. [cancerresearchuk.org]
After your treatment has finished, talk to your doctor or nurse about when it is safe to restart breast-feeding. if you are having surgery, including dental surgery, tell the doctor or dentist that you are using bortezomib. you should know that bortezomib [nlm.nih.gov]
[…] using bortezomib or for 7 months after your final dose, call your doctor immediately. do not breastfeed during your treatment with bortezomib and for 2 months after your final dose. if you are having surgery, including dental surgery, tell the doctor or dentist [medlineplus.gov]
Tell other doctors, pharmacists or dentists who prescribe or give you medicines that you are having this cancer treatment. You can visit the electronic Medicines Compendium (eMC) for more detailed information about your treatment. [macmillan.org.uk]
Respiratoric
- Sore Throat
throat; pale skin; painful or difficult urination; painful blisters on trunk of body; pinhead-sized red spots on skin; rapid breathing; sunken eyes; sweating; excessive thirst; troubled breathing with exertion; ulcers, sores or white spots in mouth; [lls.org]
Tell your doctor right away if you develop any of the following symptoms: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds, signs of an infection (such as sore throat that doesn't go away, fever, chills), unusual tiredness [webmd.com]
tongue, lips, eyes, or hands hoarseness fever, sore throat, chills, or other signs of infection unusual bruising or bleeding black and tarry stools red blood in stools bloody vomit vomiting material that looks like coffee grounds slurred speech or inability [nlm.nih.gov]
Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat .Tell your doctor right away if you have any serious side effects, including: easy bruising or bleeding, tingling/numbness/ pain /burning [medicinenet.com]
- Hoarseness
[…] or feet weakness in the arms or legs changes in the sense of touch shortness of breath cough swelling of the feet, ankles, or lower legs hives rash itching difficulty breathing or swallowing swelling of the face, throat, tongue, lips, eyes, or hands hoarseness [nlm.nih.gov]
[…] feet sudden shooting or stabbing pain, constant aching or burning pain, or muscle weakness shortness of breath, fast heartbeat, headache, dizziness, pale skin, confusion, or tiredness swelling of the feet, ankles, or lower legs hives, rash, itching hoarseness [medlineplus.gov]
[…] related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness [drugs.com]
Check with your doctor immediately if you think you may be getting an infection, or if you get a fever, chills, cough, hoarse throat, lower back or side pain or find it’s painful or difficult to urinate. [news-medical.net]
- Sputum
Results of microbiological testing, including sputum cultures, blood cultures, specific antigens for atypical pneumonia in urine and serum, were negative. Fiberoptic bronchoscopy revealed a normal bronchial tree with sparse whitish secretions. [archbronconeumol.org]
Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not [drugs.com]
- Painful Cough
Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not [drugs.com]
Gastrointestinal
- Dyspepsia
Adverse reactions CNS: headache, insomnia, dizziness, anxiety, peripheral neuropathy, reversible posterior leukoen-cephalopathy syndrome CV: tachycardia, hypotension EENT: throat tightness GI: nausea, vomiting, diarrhea, abdominal pain, dyspepsia Hematologic [medical-dictionary.thefreedictionary.com]
Applies to bortezomib: injectable powder for injection, intravenous 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 [drugs.com]
[…] arthralgia / Delayed / 11.0-17.0 back pain / Delayed / 13.0-17.0 pruritus / Rapid / 10.0-10.0 syncope / Early / 0-1.0 dysgeusia / Early / Incidence not known gastroesophageal reflux / Delayed / Incidence not known petechiae / Delayed / Incidence not known dyspepsia [pdr.net]
- Blood in Stool
[…] red blood in stools bloody vomit vomiting material that looks like coffee grounds slurred speech or inability to speak or understand speech loss of balance or coordination loss of memory paralysis (loss of ability to move a part of the body vision changes [nlm.nih.gov]
red blood in stools, bloody vomit, or vomiting material that looks like coffee grounds slurred speech or inability to speak or understand speech, confusion, paralysis (loss of ability to move a part of the body), vision changes, or loss of vision, balance [medlineplus.gov]
Liver, Gall & Pancreas
- Jaundice
PubMed Citation (50 year old woman with renal failure, multiple myeloma and amyloidosis developed jaundice 10 days after starting bortezomib and dexamethasone, which resolved despite continuing bortezomib, but recurred after stopping and was suspected [livertox.nih.gov]
[…] skin ; low blood cell counts--fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; liver problems--right-sided stomach pain, or jaundice [drugs.com]
Symptoms of liver problems include a yellow discoloration of the eyes and skin (jaundice) and changes in liver enzymes measured in blood tests. Your doctor will closely monitor you if you have liver disease. [velcade.com]
low blood cell counts --fever, chills, tiredness, flu -like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; liver problems --right-sided stomach pain, or jaundice [emedicinehealth.com]
Skin
- Blister
[…] breathing or shortness of breath; dry mouth; fainting; fever; headache; increase in heart rate; loss of voice; lower back or side pain; nasal or ear congestion or runny nose, sneezing or sore throat; pale skin; painful or difficult urination; painful blisters [lls.org]
[…] 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 [drugs.com]
[…] killing yourself difficulty thinking clearly, using good judgment, or understanding reality hallucinating (seeing things or hearing voices that do not exist) confusion restlessness thirst decreased urination loss of appetite constipation seizures skin blisters [nlm.nih.gov]
Symptoms of shingles include patches of itching, painful skin which develop into a blistering rash after several days, and should be reported to your doctor as soon as possible. [medbroadcast.com]
- Flushing
Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area. [drugs.com]
swelling and redness where the clot is hearing changes such as hearing loss or ringing in your ears (tinnitus) stroke difficulty concentrating high or low levels of thyroid hormones (hyperthyroidism) hair loss pain at the injection site runny nose flushing [cancerresearchuk.org]
Signs of a reaction can include: feeling hot or flushed shivering itching a skin rash feeling dizzy a headache feeling breathless or wheezy swelling of your face or mouth pain in your back, tummy or chest. [macmillan.org.uk]
- Erythema
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 [drugs.com]
[…] known colitis / Delayed / Incidence not known ataxia / Delayed / Incidence not known dysarthria / Delayed / Incidence not known subdural hematoma / Early / Incidence not known angina / Early / Incidence not known hematoma / Early / Incidence not known erythema [pdr.net]
- Eruptions
症例報告 ボルテゾミブによる毛包炎様および壊疽性膿皮症様皮疹の2例 Folliculitis-like and pyoderma gangrenosum-like eruptions induced by bortezomib 眞部 恵子 1, 山崎 修 1, 浅越 健治 1, 下野 玄英 2, 角南 一貴 2 Keiko MANABE 1, Osamu YAMASAKI 1, Kenji ASAGOE 1, Tsunehide SHIMONO 2, Kazutaka SUNAMI 2 2 独立行政法人国立病院機構岡山医療 [webview.isho.jp]
Urogenital
- Dark Urine
Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms /weakness. [webmd.com]
[…] production, dark urine) symptoms of liver damage (yellowing of the skin or eyes, abdominal pain, nausea, dark urine, pale stool, itching, or fluid buildup in the abdomen) symptoms of shingles (e.g., headache; sensitivity to light; aching joints followed [medbroadcast.com]
- Kidney Failure
failure). ☞ Closely monitor liver function tests and watch for signs and symptoms of hepatitis or liver failure. • Monitor nutritional and hydration status for changes caused by GI adverse effects. • Monitor CBC with white cell differential, and watch [medical-dictionary.thefreedictionary.com]
Kidney transplantation is the optimal treatment for patients with kidney failure, but many transplanted organs fail if the recipient's immune system mounts antibodies against donor proteins. [eurekalert.org]
Patients without severe liver failure( AST or ALT is greater than three times the upper limit of normal) and kidney failure(estimated EGFR is less than 50ml / min) 5. Patients with performance status 0-2 6. [upload.umin.ac.jp]
TLS can cause you to have kidney failure and the need for dialysis treatment and/or an abnormal heartbeat. Your healthcare provider may do blood tests to check for TLS. Liver problems. [velcade.com]
Kidney function : Multiple myeloma often causes increased levels of calcium in the blood and decreased kidney function, even kidney failure. [medbroadcast.com]
Neurologic
- Peripheral Neuropathy
Dosage adjustment • Moderate or severe hepatic impairment • Peripheral neuropathy • Grade 3 nonhematologic events • Grade 4 hematologic events Contraindications • Hypersensitivity to drug, mannitol, or boron Precautions Use cautiously in: • peripheral [medical-dictionary.thefreedictionary.com]
Four patients who developed a bortezomib-induced peripheral neuropathy underwent electrophysiological testing, and 1 patient had a nerve biopsy. [ncbi.nlm.nih.gov]
Neuropathy Risk of severe (grade 3 or greater) new-onset peripheral neuropathy or exacerbation of preexisting peripheral neuropathy. 1 Occurs predominantly as peripheral sensory neuropathy, but severe peripheral motor neuropathy also reported. 1 Manifestations [drugs.com]
- Tingling
You may feel numbness, tingling, or pain in your hands and feet. It may be hard for you to button your clothes, open jars, or walk as usual. The effect on the nerves may get worse with more doses of the drug. [upmc.com]
[…] or has ever had heart disease and if you have or have ever had a herpes infection (cold sores, shingles, or genital sores); diabetes; fainting; high cholesterol (fats in the blood); low or high blood pressure; peripheral neuropathy (numbness, pain, tingling [medlineplus.gov]
If you experience any of these symptoms, call your doctor immediately: pain, burning, numbness, or tingling in the hands or feet weakness in the arms or legs changes in the sense of touch shortness of breath cough swelling of the feet, ankles, or lower [nlm.nih.gov]
Side effects needing medical attention Black, tarry stools; bleeding gums; blood in urine or stool; blurred vision; body aches or pain; burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings; chest pain or tightness [lls.org]
- Paresthesia
[…] edema, anemia, fatigue, malaise, weakness, arthralgia, bone pain, muscle cramps, myalgia, back pain, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting, anorexia, anxiety, insomnia, dizziness, headache, peripheral neuropathy, rigors, paresthesia [medical-dictionary.thefreedictionary.com]
Dose Modification for VELCADE related Neuropathic Pain and/or Peripheral Sensory or Motor Neuropathy Severity of Peripheral Neuropathy Signs and Symptoms Modification of Dose and Regimen Grading based on NCI Common Toxicity Criteria CTCAE v3.0 Grade 1 (paresthesias [globalrph.com]
Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. [drugs.com]
- Asthenia
Side Effects Adverse events associated with the use of Oxytrol may include (but are not limited to) the following: Asthenia Nausea Diarrhea Appetite decreased Constipation Thrombocytopenia Peripheral neuropathy Pyrexia Vomiting Anemia Headache Insomnia [centerwatch.com]
0.01). 7 The most common adverse events (greater than or equal to 20 percent) in the KYPROLIS arm were anemia, diarrhea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral edema, nausea, bronchitis, asthenia [amgen.com]
1 26 leukopenia, 1 26 anemia, 1 26 peripheral neuropathy, 1 26 lymphopenia, 1 26 diarrhea, 1 26 nausea, 1 26 pyrexia, 1 26 cough, 26 constipation, 1 26 fatigue, 1 26 febrile neutropenia, 1 26 loss of appetite, 1 26 peripheral edema, 26 alopecia, 1 asthenia [drugs.com]
- Burning Sensation
Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. [drugs.com]
[…] with VELCADE: tiredness, generally feeling unwell, weakness feeling sick (nausea) or vomiting diarrhoea constipation loss of appetite, and/or weight, fear of gaining weight bleeding or bruising more easily than normal sensitivity, numbness, tingling or burning [news-medical.net]
They may feel numb or you may have a tingling or burning sensation in the palms of your hands or soles of your feet. These symptoms are caused by the effect of bortezomib on the nerves. It is called peripheral neuropathy. [macmillan.org.uk]
Treatment
We conclude that bortezomib could be an attractive escalating treatment option with a good side-effect profile for patients with treatment refractory CIDP. [ncbi.nlm.nih.gov]
Rituximab is approved for the treatment of CD20+ relapsed/refractory follicular lymphoma. Velcade is not indicated for the treatment of follicular lymphoma. [investor.jnj.com]
Prognosis
However, isolated CNS relapse is even less common; an event which carries a very poor prognosis. [ncbi.nlm.nih.gov]
Epidemiology
Surveillance, Epidemiology, and End Results Program. 2016. Available at http://seer.cancer.gov/statfacts/html/mulmy.html. Accessed December 13, 2016. 3. Multiple myeloma drug therapies. The MMRF. 2016. [amgen.com]
Universitätsmedizin Berlin, Berlin, Germany 2 Department of Neurology, Charité – Universitätsmedizin Berlin, Berlin, Germany 3 Neurocure Clincal Research Center, Charite Universitätsmedizin Berlin, Berlin, Germany 4 Institute of Biometry and Clinical Epidemiology [bmjopen.bmj.com]
Another important issue is the risk of developing second primary malignancies because patients are living longer from time of diagnosis. 21 Population studies 22 – 25 and data from the National Cancer Institute's Surveillance, Epidemiology, and End Results [doi.org]
The eGFR was calculated according to the chronic kidney disease epidemiology collaboration formula. 11 Adherence to immunosuppressive medication was evaluated by self-assessment of all 19 patients alive. [journals.lww.com]
The study was investigated in accordance with the ethical principles stated in the most recent version of the Declaration of Helsinki or the applicable guidelines on epidemiological studies issued by the Ministry of Health, Labor and Welfare and the Ministry [bmccancer.biomedcentral.com]
Pathophysiology
The incidence of severe adverse effects in clinical trials was lower than 5%, and severe pulmonary complications were not described before the publication of a series of 4 cases. 1 The pathophysiological mechanism of bortezomib lung injury is not well [archbronconeumol.org]
Introduction In spite of a diversity of clinical manifestations, a number of autoimmune diseases are characterised by a common pathophysiology with the production of pathogenic autoantibodies leading to an autoimmune attack on various body sites such [bmjopen.bmj.com]
The role of tumor necrosis factor alpha in the pathophysiology of human multiple myeloma: therapeutic applications. Oncogene 2001;20:4519-4527 15. Hideshima T, Chauhan D, Richardson P, et al. NF-kappa B as a therapeutic target in multiple myeloma. [nejm.org]
The pathophysiology of POEMS syndrome is not well understood, but it may be related to changes in the levels of a cytokine or an overproduction of vascular endothelial growth factor (VEGF), probably secreted by clonal plasma cells. [medicalpolicies.amerigroup.com]
Therapeutic strategies of drug repositioning targeting autophagy to induce cancer cell death: from pathophysiology to treatment. J Hematol Oncol. 2017;10:67. https://doi.org/10.1186/s13045-017-0436-9. [jhoonline.biomedcentral.com]
Prevention
Taken together, these results suggest the possibility of developing novel antihypertensive drugs that prevent CYP11B2 expression. Copyright © 2017 Elsevier Inc. All rights reserved. [ncbi.nlm.nih.gov]
Caution should be used in calculating the dose to prevent overdose. VELCADE is an antineoplastic. Procedures for proper handling and disposal should be considered. [globalrph.com]