Indications And Dose
Castration-resistant prostate cancer (specialist use only) ▶BY MOUTH ▶Adult: 160 mg once daily, for dose adjustments due to side-effects—consult product literature
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Drug reference
Castration-resistant prostate cancer (specialist use only) ▶BY MOUTH ▶Adult: 160 mg once daily, for dose adjustments due to side-effects—consult product literature
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DUE TO INTERACTIONS ▶Manufacturer advises if concurrent use of potent inhibitors of CYP2C8 is unavoidable, reduce dose to 80 mg daily.
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History or risk of QT-interval prolongation. history or risk of seizure. recent cardiovascular disease
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NICE decisions ▶Enzalutamide for metastatic hormone-relapsed prostate cancer previously treated with a docetaxel-containing regimen (July 2014) NICE TA316 Enzalutamide (Xtandi ®) is recommended, within its marketing authorisation, as an option for treating metastatic hormone-relapsed prostate cancer in adults only if their disease has progressed during or after docetaxel-containing chemotherapy, and the manufacturer provides enzalutamide with the discount agreed in the patient access scheme. This guidance does not cover the use of enzalutamide for metastatic hormone-relapsed prostate cancer previously treated with abiraterone. www.nice.org.uk/guidance/ta316/ ▶Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated (January 2016) NICE TA377 Enzalutamide (Xtandi ®) is recommended, within its marketing authorisation, as an option for treating metastatic hormone-relapsed prostate cancer: . in patients who have mild or no symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated, and . only if the manufacturer provides enzalutamide with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta377/ ▶Enzalutamide for hormone-relapsed non-metastatic prostate cancer (May 2019) NICE TA580 Enzalutamide (Xtandi ®) is not recommended, within its marketing authorisation, for treating high-risk hormone- relapsed non-metastatic prostate 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/ta580 Scottish Medicines Consortium (SMC) decisions Immune system and malignant disease SMC No. SMC2195 The Scottish Medicines Consortium has advised (October 2019) that enzalutamide (Xtandi ®) is not recommended for use within NHS Scotland for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer as the economic case was not demonstrated.
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→Appendix 1: enzalutamide
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▶Common or very common Acute coronary syndrome. anxiety. asthenia. atherosclerosis coronary artery. bone fracture. concentration impaired. fall. gynaecomastia. headache. hot flush. hypertension. ischaemic heart Immune system and malignant disease disease. memory loss. restless legs. skin reactions ▶Uncommon Cognitive disorder. leucopenia. neutropenia. seizures. visual hallucinations ▶Frequency not known Back pain. diarrhoea. face oedema. muscle complaints. muscle weakness. nausea. oral disorders. posterior reversible encephalopathy syndrome (PRES). QT interval prolongation. throat oedema. thrombocytopenia. vomiting
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Men should use condoms during treatment and for 3 months after stopping treatment if their partner is pregnant, and use condoms in combination with another effective contraceptive method if their partner is of child-bearing potential—toxicity in animal studies.
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Caution in severe impairment—no information available.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Xtandi (Astellas Pharma Ltd) Enzalutamide 40 mg Xtandi 40mg tablets | 112 tablet P £2,734.67
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Missed doses Manufacturer advises if a dose is not taken at the usual time, the missed dose should be taken as close as possible to the usual time; if a dose is missed entirely for the day, the missed dose should be taken the following day at the usual dose. Driving and skilled tasks Manufacturer advises patients and carers should be counselled on the effects on driving and performance of skilled tasks—risk of psychiatric or neurological events, including seizures.
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160 mg once daily, for dose adjustments due to
First-line fragment. Read the complete Indications and Dose section above.
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