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Enzalutamide oral


Oral formulations of enzalutamide.

Drugs List

  • enzalutamide 40mg film coated tablets
  • XTANDI 40mg film coated tablets
  • Therapeutic Indications


    Metastatic castration-resistant prostate cancer
    Non-metastatic castration-resistant prostate cancer

    Treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).

    Treatment of adult men with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic after androgen deprivation therapy when chemotherapy is not yet clinically indicated.

    Treatment of adult men with metastatic castration-resistant prostate cancer (CRPC) that has progressed on or after docetaxel therapy.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    160mg once daily.

    Additional Dosage Information

    Missed dose
    A missed dose should be taken as soon as remembered if on the same day, with a return to the normal dose schedule the following day. Patients should not take extra tablets to make up for the missed dose.

    Dose reductions
    Grade 3 or greater toxicity or intolerable adverse reactions: Interrupt treatment for 1 week or until symptoms subside to grade 2 or less. Resume at same dose or at a reduced dose of 120mg or 80mg.

    Concomitant use with strong CYP2C8 inhibitors
    Concomitant use of strong CYP2C8 inhibitors should be avoided, however if co-administration is necessary reduce dose of enzalutamide to 80mg once daily.


    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Predisposition to seizures
    Cardiovascular disorder
    Electrolyte imbalance
    Hereditary fructose intolerance
    History of seizures
    History of torsade de pointes
    Severe renal impairment

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    May reduce seizure threshold
    Treatment to be initiated and supervised by a specialist
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor serum electrolytes
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
    Interrupt treatment and/or reduce dose for any grade 3 toxicity
    May cause impaired fertility
    Male: Use of condoms required during and for 3 months after treatment
    Male: Contraception required for partners for 3 months after treatment

    An increased drug half life has been observed in patients with severe hepatic impairment. However, the manufacturer advise no dose adjustment is required.

    Posterior Reversible Encephalopathy Syndrome (PRES) also known as Reversible Posterior Leucoencephalopathy Syndrome (RPLS)
    Posterior reversible encephalopathy syndrome (PRES) has been reported in some patients treated with this agent. If patients present with symptoms indicating PRES such as headache, altered mental state, seizures and visual disturbances, an MRI should be performed. If PRES is diagnosed, treatment should be discontinued and adequate blood pressure and seizure control administration is advisable. The safety of reinstating treatment in patients previously experiencing PRES is unknown.

    Pregnancy and Lactation


    Enzalutamide is not indicated in women.


    Enzalutamide is not indicated in women.

    Side Effects

    Attention disturbances
    Back pain
    Cardiac disorders
    Cognitive impairment
    Dry skin
    Facial oedema
    Hot flushes
    Hypersensitivity reactions
    Memory disturbances
    Muscle spasm
    Muscle weakness
    Oedema of the lips
    Pharyngeal oedema
    Posterior reversible encephalopathy syndrome (PRES)
    Prolongation of QT interval
    Restless legs
    Tongue oedema
    Visual hallucinations


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111.

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2018

    Reference Sources

    NICE Evidence Services Available at: Last accessed: 23 March 2018

    Summary of Product Characteristics: Xtandi 40 mg capsules. Astellas Pharma Ltd. Revised October 2018.
    Summary of Product Characteristics: Xtandi 40 mg film coated tablets. Astellas Pharma Ltd. Revised October 2018.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.