Drug Action
Bortezomib is a proteasome inhibitor.
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Individual generic drug information
Extracted information for Bortezomib only.
Bortezomib is a proteasome inhibitor.
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Multiple myeloma (specialist use only) | Mantle cell lymphoma (specialist use only) ▶BY INTRAVENOUS INJECTION, OR BY SUBCUTANEOUS INJECTION ▶Adult: (consult product literature or local protocols)
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Acute diffuse infiltrative pulmonary disease. pericardial disease
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Amyloidosis. cardiovascular disease. consider antiviral prophylaxis for herpes zoster infection. dehydration. diabetes (may affect blood glucose). history of syncope. pulmonary disease (discontinue if interstitial lung disease develops). risk factors for seizures. risk of neuropathy—consult product literature
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NICE decisions ▶Bortezomib for previously untreated mantle cell lymphoma (December 2015) NICE TA370 Bortezomib is recommended as an option for the treatment of previously untreated mantle cell lymphoma in adults for whom haematopoietic stem cell transplantation is unsuitable. www.nice.org.uk/guidance/ta370 ▶Bortezomib for induction therapy in multiple myeloma before high-dose chemotherapy and autologous stem cell transplantation (April 2014) NICE TA311 Bortezomib is recommended as an option within its marketing authorisation, in combination with dexamethasone, or with dexamethasone and thalidomide, for the induction treatment of adults with previously untreated multiple myeloma, who are eligible for high- dose chemotherapy with haematopoietic stem cell transplantation. www.nice.org.uk/guidance/ta311 ▶Bortezomib and thalidomide for the first-line treatment of multiple myeloma (July 2011) NICE TA228 Immune system and malignant disease Bortezomib in combination with an alkylating drug and a corticosteroid is recommended as an option for the first- line treatment of multiple myeloma if: . high-dose chemotherapy with stem cell transplantation is considered inappropriate and . the person is unable to tolerate or has contra- indications to thalidomide. www.nice.org.uk/guidance/ta228 ▶Bortezomib monotherapy for relapsed multiple myeloma (October 2007) NICE TA129 Bortezomib monotherapy is an option for the treatment of progressive multiple myeloma in patients who are at first relapse having received one prior therapy and who have undergone, or are unsuitable for, bone-marrow transplantation, under the following circumstances: . the response to bortezomib is measured using serum M protein after a maximum of four cycles of treatment, and treatment is continued only in patients who have a reduction in serum M protein of 50% or more (where serum M protein is not measurable, an appropriate alternative biochemical measure of response should be used) and . the manufacturer rebates the full cost of bortezomib if there is an inadequate response (as defined above) after four cycles of treatment. www.nice.org.uk/TA129 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium, has advised (January 2014) that bortezomib (Velcade ®) is accepted for restricted use within NHS Scotland in combination with dexamethasone and thalidomide for the induction treatment of adults with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
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Extracted information for Bortezomib only.
Bortezomib injection is for intravenous or subcutaneous administration only. Inadvertent intrathecal administration with fatal outcome has been reported.
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→Appendix 1: bortezomib
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▶Common or very common Anaemia. anxiety. appetite abnormal. arrhythmias. asthenia. chills. constipation. cough. decreased leucocytes. diabetes mellitus. diarrhoea . dizziness. dysphagia. dyspnoea. electrolyte imbalance. encephalopathy. enzyme abnormality. eye inflammation. fever. fluid imbalance. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. hair disorder. headaches. hearing impairment. heart failure. hepatic disorders. hiccups. hyperbilirubinaemia. hypersensitivity . hypertension. hypotension. increased risk of infection. ischaemic heart disease. lethargy. loss of consciousness. malaise. mood altered. muscle complaints. muscle weakness. nausea. nerve disorders. neuromuscular dysfunction. neutropenia. oedema. oral disorders. oropharyngeal complaints. pain. renal impairment. sensation abnormal. sepsis. skin reactions. sleep disorder . syncope. taste altered. thrombocytopenia. tinnitus. ventricular dysfunction. vertigo. vision disorders. vomiting. weight changes ▶Uncommon Altered smell sensation. angioedema. antibiotic associated colitis. arthritis. azotaemia. cardiac arrest. cardiomyopathy. cardiovascular disorder. cerebrovascular insufficiency. chest discomfort. circulation impaired. circulatory collapse. coagulation disorders. concentration impaired. confusion. Cushing’s syndrome. dry eye. dysphonia. ear discomfort. embolism and thrombosis. eye discomfort. eye disorders. failure to thrive. gait abnormal. gas exchange abnormal. genital pain. haemolytic anaemia. hallucination. hyperthyroidism. increased leucocytes. injury. irritable bowel syndrome. joint disorders. lymphadenopathy. memory loss. movement disorders. mucous membrane disorder. myopathy. neurotoxicity. palpitations. pancreatitis. pancytopenia. pericardial disorders. pericarditis. posterior reversible encephalopathy syndrome (PRES) (discontinue). proteinuria. psychiatric disorders. psychotic disorder. pulmonary hypertension. pulmonary oedema. reflexes abnormal. respiratory disorders. rhinorrhoea. seizure. sensation of pressure. severe cutaneous adverse reactions (SCARs). sexual dysfunction. shock. SIADH. skin mass. skin ulcers. speech disorder. sweat changes. temperature sensation altered. thirst change. tremor. tumour lysis syndrome. urinary disorders. urinary tract disorder. vascular disorders. vasculitis. vasodilation ▶Rare or very rare Acidosis. acute coronary syndrome. alcohol intolerance. amyloidosis. apnoea. ascites. atrioventricular block. bladder irritation. blood disorders. bone disorder. bone fracture. brain oedema. breast disorder. cardiac valve disorder. cholelithiasis. CNS haemorrhage. cognitive disorder. coma. coronary artery insufficiency. delirium. drooling. ear disorder. erythromelalgia. fistula. gout. healing impaired. hypothyroidism. inflammation. lymphoedema. macrophage activation. mass. meningitis. metabolic disorder. multi organ failure. nail disorder. neoplasm malignant. neoplasms. nervous system disorder. paralysis . paresis. pelvic pain. perforation. photosensitivity reaction. platelet abnormalities. procedural complications . prostatitis. radiation injury. seborrhoea. sudden death. suicidal ideation. testicular disorders. throat complaints. ulcer. vaginal ulceration. venous insufficiency. vitamin deficiencies ▶Frequency not known Herpes zoster reactivation. JC virus infection. progressive multifocal leukoencephalopathy (PML)
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Manufacturer advises effective contraception during and for 3 months after treatment in men or women.
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Toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Discontinue breast-feeding.
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Manufacturer advises caution in moderate to severe impairment–monitor for toxicity. Dose adjustments Manufacturer advises reduce dose in moderate to severe impairment—consult product literature.
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No information available for creatinine clearance less than 20 mL/minute/1.73 m2.
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▶Monitor blood-glucose concentration in patients on oral antidiabetics. ▶Monitor for symptoms of progressive multifocal leucoencephalopathy (presenting as new or worsening neurological signs or symptoms)—discontinue treatment if diagnosed. ▶Chest x-ray recommended before treatment to monitor for pulmonary disease—discontinue if interstitial lung disease develops.
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Extracted information for Bortezomib only.
There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: solution for injection Solution for injection ▶Bortezomib (Non-proprietary) Bortezomib 2.5 mg per 1 ml Bortezomib 3.5mg/1.4ml solution for injection vials | 1 vial P £495.55 (Hospital only) Powder for solution for injection ▶Bortezomib (Non-proprietary) Bortezomib 1 mg Bortezomib 1mg powder for solution for injection vials | 1 vial P £217.82 (Hospital only) Bortezomib 2.5 mg Bortezomib 2.5mg powder for solution for injection vials | 1 vial P £544.56 (Hospital only) Bortezomib 3.5 mg Bortezomib 3.5mg powder for solution for injection vials | 1 vial P £762.38 (Hospital only) ▶Velcade (Janssen-Cilag Ltd) Bortezomib 3.5 mg Velcade 3.5mg powder for solution for injection vials | 1 vial P £762.38 (Hospital only)
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Filter the extracted dose blocks for this individual drug.
First line only; read the complete Indications and dose section above.
(consult product literature or local protocols)
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1038