Drug Action
Midostaurin is an inhibitor of multiple tyrosine kinases.
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Drug reference
Midostaurin is an inhibitor of multiple tyrosine kinases.
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Acute myeloid leukaemia (specialist use only) ▶BY MOUTH ▶Adult: 50 mg twice daily, on days 8–21 of induction and consolidation chemotherapy cycles; for administration following consolidation chemotherapy, and dose adjustment or treatment interruption due to side- effects—consult product literature Aggressive systemic mastocytosis (specialist use only) | Systemic mastocytosis with associated haematological neoplasm (specialist use only) | Mast cell leukaemia (specialist use only) ▶BY MOUTH ▶Adult: 100 mg twice daily, for dose adjustment or treatment interruption due to side-effects—consult product literature
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Active severe infection (control before initiation of monotherapy). elderly (limited experience). patients at risk of congestive heart failure. risk factors for QT-interval prolongation
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NICE decisions ▶Midostaurin for untreated acute myeloid leukaemia (June 2018) NICE TA523 Midostaurin is recommended, within its marketing authorisation, as an option in adults for treating newly diagnosed acute FLT3-mutation-positive myeloid leukaemia with standard daunorubicin and cytarabine as induction therapy, with high-dose cytarabine as consolidation therapy, and alone after complete response as maintenance therapy. It is recommended only if the manufacturer provides midostaurin with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta523 Scottish Medicines Consortium (SMC) decisions SMC No. 1330/18 The Scottish Medicines Consortium has advised (June 2018) that midostaurin (Rydapt ®) is accepted for use within NHS Scotland for the treatment of adults with newly diagnosed Immune system and malignant disease acute myeloid leukaemia who are FMS-like tyrosine kinase 3 (FLT3) mutation-positive, when used in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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Immune system and malignant disease RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: midostaurin
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▶Common or very common Asthenia. bruising. chills. concentration impaired. constipation. cough. cystitis. diarrhoea. dizziness. dyspepsia. dyspnoea. fall. febrile neutropenia. fever. haemorrhage. headache. hyperglycaemia. hypersensitivity. hypotension. increased risk of infection. nausea. oedema. oropharyngeal pain. respiratory disorders. sepsis. tremor. vertigo. vomiting. weight increased ▶Frequency not known Cardiac disorder. congestive heart failure. QT interval prolongation
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Manufacturer advises perform pregnancy test in women of childbearing potential within 7 days prior to treatment initiation; effective contraception must be used during treatment and for at least 4 months after stopping treatment—additional barrier method recommended in women using hormonal contraceptives. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid during treatment and for 4 months after stopping treatment— present in milk in animal studies.
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Manufacturer advises caution in severe impairment and monitor for toxicity—no information available.
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Manufacturer advises caution in severe impairment and monitor for toxicity—limited information available.
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▶Manufacturer advises monitor white blood cell count regularly, especially at treatment initiation; also monitor for signs and symptoms of infection. ▶Manufacturer advises assess left ventricular ejection fraction in patients at risk of congestive heart failure at baseline and during treatment as clinically indicated; consider performing ECGs if concomitant use with drugs that can prolong QT-interval. ▶Manufacturer advises monitor for pulmonary symptoms indicative of interstitial lung disease or pneumonitis.
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There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 21, 25 EXCIPIENTS: May contain Alcohol ▶Rydapt (Novartis Pharmaceuticals UK Ltd) A Midostaurin 25 mg Rydapt 25mg capsules | 56 capsule P £5,609.94
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50 mg twice daily, on days 8–21 of induction and
First-line fragment. Read the complete Indications and Dose section above.
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100 mg twice daily, for dose adjustment or
First-line fragment. Read the complete Indications and Dose section above.
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