Drug Action
Dasatinib is a tyrosine kinase inhibitor.
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Drug reference
Dasatinib is a tyrosine kinase inhibitor.
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Chronic phase chronic myeloid leukaemia (initiated by a specialist) ▶BY MOUTH USING TABLETS ▶Adult: 100 mg once daily, then increased if necessary up to 140 mg once daily, for dose adjustment due to side-effects—consult product literature ▶BY MOUTH USING ORAL SUSPENSION ▶Adult (body-weight 30–44 kg): 105 mg once daily, adjust dose based on changes in body-weight every 3 months or more often if necessary; for dose escalation, or dose adjustment due to side-effects—consult product literature ▶Adult (body-weight 45 kg and above): 120 mg once daily, adjust dose based on changes in body-weight every 3 months or more often if necessary; for dose escalation, or dose adjustment due to side-effects— consult product literature Accelerated and blast phase chronic myeloid leukaemia [resistant or intolerant to prior therapy] (initiated by a specialist) | Acute lymphoblastic leukaemia [resistant or intolerant to prior therapy] (initiated by a specialist) ▶BY MOUTH USING TABLETS ▶Adult: 140 mg once daily, then increased if necessary up to 180 mg once daily, for dose adjustment due to side-effects—consult product literature DOSE EQUIVALENCE AND CONVERSION ▶Sprycel ® film-coated tablets and Sprycel ® powder for oral suspension are not bioequivalent. Follow correct dosing recommendations for the dosage form when switching formulations.
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Hepatitis B infection. risk of cardiac dysfunction (monitor closely). susceptibility to QT- interval prolongation (correct hypokalaemia or hypomagnesaemia before starting treatment) 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 ▶Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia (CML) (December 2016) NICE TA426 Dasatinib is recommended, within its marketing authorisation, as an option for untreated chronic phase Philadelphia-chromosome-positive CML in adults, only if the manufacturer provides it with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta426 Immune system and malignant disease ▶Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia (CML) (December 2016) NICE TA425 Dasatinib is recommended as an option for treating chronic or accelerated phase Philadelphia-chromosome- positive CML in adults, if they cannot have imatinib, or their disease is imatinib-resistant and the manufacturer provides dasatinib with the discount agreed in the patient access scheme. 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 NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta425 Scottish Medicines Consortium (SMC) decisions SMC No. 370/07 The Scottish Medicines Consortium has advised (September 2016) that dasatinib (Sprycel ®) is accepted for use within NHS Scotland for the treatment of adults with chronic, accelerated or blast phase chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate, only if the manufacturer provides dasatinib with the discount agreed in the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. 1170/16 The Scottish Medicines Consortium has advised (September 2016) that dasatinib (Sprycel ®) is accepted for use within NHS Scotland for the treatment of adults with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase, only if the manufacturer provides dasatinib with the discount agreed in the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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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 dasatinib 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: dasatinib
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▶Common or very common Alopecia. anaemia. appetite abnormal. arrhythmias. arthralgia. asthenia. bone marrow depression. cardiac disorder. cardiomyopathy. chest pain. chills. constipation. cough. depression. diarrhoea. dizziness. drowsiness. dry eye. dyspnoea. eye inflammation. facial swelling. fever. fluid imbalance. flushing. gastrointestinal discomfort. gastrointestinal disorders. genital abnormalities. haemorrhage. headache . heart failure. hypertension. hyperuricaemia. increased Immune system and malignant disease risk of infection. insomnia. milia. mucositis. muscle complaints. muscle weakness. musculoskeletal stiffness. myocardial dysfunction. nausea. nerve disorders. neutropenia. oedema. oral disorders. pain. palpitations. pericardial effusion. perinephric effusion. peripheral swelling. pulmonary hypertension. pulmonary oedema. respiratory disorders. sepsis. skin reactions. sweat changes. taste altered. thrombocytopenia. tinnitus. vision disorders. vomiting. weight changes ▶Uncommon Acute coronary syndrome. anxiety. arthritis. ascites. asthma. cardiac inflammation. cardiomegaly. cerebrovascular insufficiency. cholecystitis. CNS haemorrhage. confusion. dysphagia. embolism and thrombosis. emotional lability. excessive tearing. gynaecomastia. hair disorder. hearing loss. hepatic disorders. hypercholesterolaemia. hypoalbuminaemia. hypotension. hypothyroidism. ischaemic heart disease. libido decreased. lymphadenopathy. lymphopenia. malaise. memory loss. menstrual disorder. movement disorders. myopathy. nail disorder. osteonecrosis. pancreatitis. panniculitis. penile disorders. photosensitivity reaction. proteinuria. QT interval prolongation. renal impairment. scrotal oedema. skin ulcer. syncope. tendinitis. testicular swelling. tremor. tumour lysis syndrome. urinary frequency increased. vertigo. vulvovaginal swelling ▶Rare or very rare Cardiac arrest. dementia. diabetes mellitus. epiphyses delayed fusion. facial paralysis. gait abnormal. growth retardation. hypersensitivity vasculitis. hyperthyroidism. pure red cell aplasia. seizure. thyroiditis ▶Frequency not known Hepatitis B reactivation. nephrotic syndrome. Stevens-Johnson syndrome. thrombotic microangiopathy
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Effective contraception required during treatment.
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Manufacturer advises avoid unless potential benefit outweighs risk—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.
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▶Manufacturer advises evaluate for signs and symptoms of underlying cardiopulmonary disease before initiation of therapy—echocardiography should be performed at treatment initiation in patients with symptoms of cardiac disease and considered for patients with risk factors for cardiac or pulmonary disease. ▶Manufacturer advises monitor patients with risk factors or a history of cardiac disease for signs or symptoms of cardiac dysfunction during treatment. ▶When used for Accelerated or blast phase chronic myeloid leukaemia or Acute lymphoblastic leukaemia Manufacturer advises monitor full blood count weekly for the first 2 months, then monthly or as clinically indicated thereafter. ▶When used for Chronic phase chronic myeloid leukaemia Manufacturer advises monitor full blood count every 2 weeks for 3 months, then every 3 months or as clinically indicated thereafter.
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There can be variation in the licensing of different medicines containing the same drug. Oral suspension EXCIPIENTS: May contain Benzyl alcohol, sucrose ▶Sprycel (Bristol-Myers Squibb Pharmaceuticals Ltd) Dasatinib (as Dasatinib monohydrate) 10 mg per 1 ml Sprycel 10mg/ml oral suspension | 99 ml P £626.74 Tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Dasatinib (Non-proprietary) Dasatinib (as Dasatinib monohydrate) 20 mg Dasatinib 20mg tablets | 60 tablet P £650.00 DT = £1,252.48 Dasatinib (as Dasatinib monohydrate) 50 mg Dasatinib 50mg tablets | 60 tablet P £1,200.00 DT = £2,504.96 Dasatinib (as Dasatinib monohydrate) 80 mg Dasatinib 80mg tablets | 30 tablet P £1,200.00 DT = £2,504.96 Dasatinib (as Dasatinib monohydrate) 100 mg Dasatinib 100mg tablets | 30 tablet P £1,200.00 DT = £2,504.96 Dasatinib (as Dasatinib monohydrate) 140 mg Dasatinib 140mg tablets | 30 tablet P £1,200.00 DT = £2,504.96 ▶Sprycel (Bristol-Myers Squibb Pharmaceuticals Ltd) Dasatinib (as Dasatinib monohydrate) 20 mg Sprycel 20mg tablets | 60 tablet P £1,252.48 DT = £1,252.48 Dasatinib (as Dasatinib monohydrate) 50 mg Sprycel 50mg tablets | 60 tablet P £2,504.96 DT = £2,504.96 Dasatinib (as Dasatinib monohydrate) 80 mg Sprycel 80mg tablets | 30 tablet P £2,504.96 DT = £2,504.96 Dasatinib (as Dasatinib monohydrate) 100 mg Sprycel 100mg tablets | 30 tablet P £2,504.96 DT = £2,504.96 Dasatinib (as Dasatinib monohydrate) 140 mg Sprycel 140mg tablets | 30 tablet P £2,504.96 DT = £2,504.96
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100 mg once daily, then increased if necessary
First-line fragment. Read the complete Indications and Dose section above.
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105 mg once daily, adjust
First-line fragment. Read the complete Indications and Dose section above.
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120 mg once daily,
First-line fragment. Read the complete Indications and Dose section above.
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140 mg once daily, then increased if necessary
First-line fragment. Read the complete Indications and Dose section above.
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