Drug Action
Imatinib is a tyrosine kinase inhibitor.
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Individual generic drug information
Extracted information for Imatinib only.
Imatinib is a tyrosine kinase inhibitor.
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Treatment of chronic myeloid leukaemia in chronic phase after failure with interferon alfa ▶BY MOUTH ▶Adult: 400 mg once daily, increased if necessary up to 800 mg daily in 2 divided doses Treatment of chronic myeloid leukaemia in accelerated phase, or in blast crisis ▶BY MOUTH Immune system and malignant disease ▶Adult: 600 mg once daily, then increased if necessary up to 800 mg daily in 2 divided doses Treatment of newly diagnosed acute lymphoblastic leukaemia (in combination with other chemotherapy) | Monotherapy for relapsed or refractory acute lymphoblastic leukaemia ▶BY MOUTH ▶Adult: 600 mg once daily Treatment of c-kit (CD117)-positive unresectable or metastatic malignant gastro-intestinal stromal tumours (GIST) | Adjuvant treatment following resection of c-kit (CD117)-positive GIST, in patients at significant risk of relapse | Treatment of myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor gene rearrangement ▶BY MOUTH ▶Adult: 400 mg once daily Treatment of unresectable dermatofibrosarcoma protuberans | Recurrent or metastatic dermatofibrosarcoma protuberans, in patients who cannot have surgery ▶BY MOUTH ▶Adult: 800 mg daily in 2 divided doses Treatment of advanced hypereosinophilic syndrome and chronic eosinophilic leukaemia ▶BY MOUTH ▶Adult: 100–400 mg once daily
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Cardiac disease. hepatitis B infection. history of renal failure. risk factors for heart failure CAUTIONS, FURTHER INFORMATION ▶Hepatitis B infection The MHRA advises that patients who are carriers of hepatitis B virus should be closely monitored for signs and symptoms of active infection throughout treatment and for several months after stopping treatment; expert advice should be sought for patients who test positive for hepatitis B virus and in those with active infection.
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NICE decisions ▶Imatinib for the adjuvant treatment of gastro-intestinal stromal tumours (November 2014) NICE TA326 Imatinib is recommended as an option for adjuvant treatment of adult patients who are at high risk of relapse after surgery for KIT (CD117)-positive gastro-intestinal stromal tumours, as defined by the Miettinen 2006 criteria (based on tumour size, location, and mitotic rate), for up to 3 years. Patients currently receiving treatment initiated within the NHS with imatinib that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta326 ▶Imatinib for chronic myeloid leukaemia (updated January 2016) NICE TA70 Imatinib is recommended as an option for patients with Philadelphia-chromosome-positive chronic myeloid leukaemia who initially present in the accelerated phase or with blast crisis. Imatinib is also recommended as an option for patients who present in the chronic phase and then progress to the accelerated phase or blast crisis if they have not received imatinib previously. www.nice.org.uk/guidance/ta70 ▶Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours (updated November 2010) NICE TA86 Imatinib 400 mg daily is recommended as first-line management of KIT (CD117)-positive unresectable or metastatic, or both, gastro-intestinal stromal tumours. Continued therapy is recommended only if a response to initial treatment is achieved within 12 weeks. Patients who have responded should be assessed at 12-week intervals. Discontinue if tumour ceases to respond. www.nice.org.uk/guidance/ta86 ▶Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours (November 2010) NICE TA209 Imatinib 600 mg daily or 800 mg daily is not recommended for unresectable or metastatic, or both, gastro-intestinal stromal tumours whose disease has progressed after treatment with imatinib 400 mg daily. www.nice.org.uk/guidance/ta209 ▶Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia (CML) (December 2016) NICE TA426 Imatinib is recommended as an option for untreated chronic phase Philadelphia-chromosome-positive CML in adults. www.nice.org.uk/guidance/ta426 ▶Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia (CML) (December 2016) NICE TA425 High-dose imatinib (600 mg in the chronic phase or 800 mg in the accelerated and blast-crisis phases) is not recommended for treating Philadelphia-chromosome- positive CML in adults whose disease is imatinib-resistant. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta425 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (March 2002) that imatinib (Glivec ®) should be used for chronic myeloid leukaemia only under specialist supervision in accordance with British Society of Haematology guidelines (November 2001). The Scottish Medicines Consortium has also advised (August 2010) that imatinib (Glivec ®) is accepted for restricted use within NHS Scotland for the treatment of adult patients who are at significant risk of relapse following resection of a KIT (CD117) positive gastrointestinal stromal tumour (GIST) and who are at high risk of recurrence following complete resection (according to the Armed Forces Institute of Pathology (AFIP) risk criteria).
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Extracted information for Imatinib only.
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938. MHRA/CHM ADVICE (MAY 2016): RISK OF HEPATITIS B VIRUS REACTIVATION WITH BCR-ABL TYROSINE KINASE INHIBITORS An EU wide review has concluded that imatinib can cause hepatitis B reactivation; the MHRA recommends establishing hepatitis B virus status in all patients before initiation of treatment.
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→Appendix 1: imatinib
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▶Common or very common Alopecia. anaemia. appetite abnormal. asthenia. bone marrow disorders. chills. constipation. cough. diarrhoea. dizziness. dry eye. dry mouth. dyspnoea. excessive tearing. eye inflammation. fever. fluid imbalance. flushing. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. headaches. insomnia. joint disorders. muscle complaints. nausea. neutropenia. oedema. pain. photosensitivity reaction. sensation abnormal. skin reactions. sweat changes. taste altered. thrombocytopenia. vision blurred. vomiting. weight changes ▶Uncommon Anxiety. arrhythmias. ascites. breast abnormalities. broken nails. burping. chest pain. CNS haemorrhage. congestive heart failure. depression. drowsiness. dysphagia. electrolyte imbalance. eosinophilia. eye discomfort. gout. gynaecomastia. hearing loss. hepatic disorders. hyperbilirubinaemia. hyperglycaemia. hypertension. hyperuricaemia. hypotension. increased risk of infection. laryngeal pain. lymphadenopathy. lymphopenia. malaise. memory loss. menstrual cycle irregularities. nerve disorders. oral disorders. palpitations. pancreatitis. peripheral coldness. pulmonary oedema. Raynaud’s phenomenon. renal impairment. renal pain. respiratory disorders. restless legs. scrotal oedema. sepsis. sexual dysfunction. syncope . thrombocytosis. tinnitus. tremor. urinary frequency increased. vertigo ▶Rare or very rare Angina pectoris. angioedema. arthritis. cardiac arrest. cataract. confusion. glaucoma. haemolytic anaemia. haemorrhagic ovarian cyst. hepatic failure (including fatal cases). hypersensitivity vasculitis. inflammatory bowel disease. intracranial pressure increased. muscle weakness. myocardial infarction. myopathy. nail discolouration. pericardial disorders. pulmonary hypertension. seizure. severe cutaneous adverse reactions (SCARs). tumour lysis syndrome ▶Frequency not known Embolism and thrombosis. hepatitis B reactivation. neoplasm complications. osteonecrosis. pericarditis
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Effective contraception required during treatment.
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Manufacturer advises avoid unless potential benefit outweighs risk. 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. Dose adjustments Manufacturer advises max. 400 mg once daily; consider further dose reduction if not tolerated— consult product literature.
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Dose adjustments Maximum starting dose 400 mg daily if creatinine clearance less than 60 mL/minute; reduce dose further if not tolerated.
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▶Monitor for gastrointestinal haemorrhage. ▶Monitor complete blood counts regularly. ▶Monitor for fluid retention. ▶Monitor liver function. ▶Monitor growth in children (may cause growth retardation).
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Extracted information for Imatinib only.
Tablets may be dispersed in water or apple juice.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 21, 27 ▶Imatinib (Non-proprietary) Imatinib (as Imatinib mesilate) 100 mg Imatinib 100mg tablets | 30 tablet P £486.66 | 60 tablet P £104.49 DT = £478.08 (Hospital only) | 60 tablet P £973.32 DT = £478.08 Imatinib (as Imatinib mesilate) 400 mg Imatinib 400mg tablets | 30 tablet P £208.98 DT = £1,133.41 (Hospital only) | 30 tablet P £1,946.67 DT = £1,133.41 | 60 tablet P £3,893.34 ▶Glivec (Novartis Pharmaceuticals UK Ltd) A Imatinib (as Imatinib mesilate) 100 mg Glivec 100mg tablets | 60 tablet P £973.32 DT = £478.08 Immune system and malignant disease Imatinib (as Imatinib mesilate) 400 mg Glivec 400mg tablets | 30 tablet P £1,946.67 DT = £1,133.41
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Extracted information for Imatinib only.
Patients or carers should be given advice on how to administer imatinib tablets.
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Filter the extracted dose blocks for this individual drug.
First line only; read the complete Indications and dose section above.
400 mg once daily, increased if necessary up to
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1062
First line only; read the complete Indications and dose section above.
600 mg once daily, then increased if necessary
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1062
First line only; read the complete Indications and dose section above.
600 mg once daily
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1062
First line only; read the complete Indications and dose section above.
400 mg once daily
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1062
First line only; read the complete Indications and dose section above.
800 mg daily in 2 divided doses
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1062
First line only; read the complete Indications and dose section above.
100–400 mg once daily
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1062