Drug Action
Osimertinib is a tyrosine kinase inhibitor.
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Drug reference
Osimertinib is a tyrosine kinase inhibitor.
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Locally advanced or metastatic epidermal growth factor receptor T790M mutation-positive non-small-cell lung cancer (specialist use only) ▶BY MOUTH ▶Adult: 80 mg once daily, for dose adjustment due to side-effects—consult product literature
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Congenital long QT syndrome
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Elderly (more frequent dose adjustments may be required). history of interstitial lung disease. radiation pneumonitis requiring steroid treatment. risk factors for QTc interval prolongation
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Immune system and malignant disease NICE decisions ▶Osimertinib for treating locally advanced or metastatic EGFR T790M mutation-positive non-small-cell lung cancer (October 2016) NICE TA416 Osimertinib (Tagrisso ®) is recommended as an option, for use within the Cancer Drugs Fund, for treating locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer in adults whose disease has progressed only: . after first-line treatment with an EGFR tyrosine kinase inhibitor, and . if the conditions in the managed access agreement for osimertinib are followed. 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/ta416 ▶Osimertinib for untreated EGFR mutation-positive non-small- cell lung cancer (January 2020) NICE TA621 Osimertinib (Tagrisso ®) is not recommended, within its marketing authorisation, for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer in adults. 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/ta621 Scottish Medicines Consortium (SMC) decisions SMC No. 1214/17 The Scottish Medicines Consortium has advised (February 2017) that osimertinib (Tagrisso ®) is accepted for restricted use within NHS Scotland for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer, only in patients who have received previous treatment with an EGFR tyrosine kinase inhibitor. 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. SMC No. SMC2171 The Scottish Medicines Consortium has advised (September 2019) that osimertinib (Tagrisso ®) is not recommended for use within NHS Scotland as monotherapy for the first-line treatment of adults with locally advanced or metastatic non-small-cell lung cancer with activating epidermal growth factor receptor mutations, as the economic case was not demonstrated.
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: osimertinib
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▶Common or very common Diarrhoea. eyelid pruritus. increased risk of infection. nail discolouration. nail disorders. respiratory disorders. skin reactions. stomatitis ▶Uncommon Eye disorders. eye inflammation. QT interval prolongation
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Manufacturer advises use of effective, non-hormonal, contraception during and for 2 months after treatment in women, and 4 months after treatment in men.
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Manufacturer advises avoid unless essential—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—may be present in milk based on animal studies.
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Manufacturer advises avoid in severe impairment (no information available).
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Manufacturer advises caution in severe and end-stage impairment—limited information available.
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Manufacturer advises monitor ECG and electrolytes periodically in patients with risk factors for QTc interval prolongation; dose adjustment is advised if QTc interval is more than 500 milliseconds on at least 2 separate ECGs—consult product literature.
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Manufacturer advises tablet may be dispersed in 50 mL of non-carbonated water, by stirring until dispersed and swallowed immediately (do not crush). The residue must then be re-dispersed in an additional half a glass of water and immediately swallowed. Manufacturer advises if administration via a nasogastric tube is required, the tablet may be dispersed in 15 mL of non-carbonated water, by stirring until dispersed and the residue re-dispersed in an additional 15 mL of water (do not crush). The total 30 mL of liquid should then be administered as per the nasogastric tube manufacturer’s instructions with appropriate water flushes; the solution should be administered within 30 minutes of adding the tablets to water.
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There can be variation in the licensing of different medicines containing the same drug. Tablet ▶Tagrisso (AstraZeneca UK Ltd) A Osimertinib (as Osimertinib mesylate) 40 mg Tagrisso 40mg tablets | 30 tablet P £5,770.00 Osimertinib (as Osimertinib mesylate) 80 mg Tagrisso 80mg tablets | 30 tablet P £5,770.00
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Missed doses Manufacturer advises if a dose is more than 12 hours late, the missed dose should not be taken and the next dose should be taken at the normal time.
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80 mg once daily, for dose adjustment due to
First-line fragment. Read the complete Indications and Dose section above.
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