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Darolutamide oral


Oral formulations of darolutamide.

Drugs List

  • darolutamide 300mg tablets
  • NUBEQA 300mg tablets
  • Therapeutic Indications


    Non-metastatic castration-resistant prostate cancer



    600mg taken twice daily.

    Patients with Renal Impairment

    Estimated glomerular filtration rate (eGFR) 15 to 29ml/min/1.73m squared: Recommended starting dose of 300mg twice daily.

    Patients with Hepatic Impairment

    Moderate and severe impairment: Recommended starting dose of 300mg twice daily.

    Additional Dosage Information

    Grade 3 or greater toxicity or any intolerable adverse reaction
    Withold or reduce dose to 300mg twice daily. Resume at dose of 600mg twice daily once symptoms resolve.


    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    History of torsade de pointes
    Lactose intolerance
    Moderate hepatic impairment
    Renal impairment - creatinine clearance 15-29ml/minute
    Within 6 months of clinically significant cardiovascular disease

    Correct electrolyte disorders before treatment
    Reduce dose in patients with moderate hepatic impairment
    Reduce dose in patients with severe renal impairment
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor patients with hepatic impairment for adverse effects
    Monitor patients with renal impairment for adverse effects
    Monitor serum electrolytes
    Interrupt treatment and/or reduce dose for any grade 3 toxicity
    Advise patient not to take St John's wort concurrently
    May cause impaired fertility
    Male: Contraception required during and for 1 week after treatment

    Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated.

    Pregnancy and Lactation


    Not indicated for use in women.


    Not indicated for use in women.

    Side Effects

    Angina pectoris
    Arterial occlusion
    Arterial stenosis
    Cardiac failure
    Cardiogenic shock
    Congestive cardiac failure
    Coronary artery disorder
    Increase in AST level
    Musculoskeletal pain
    Myocardial infarction
    Myocardial ischaemia
    Painful extremities
    Reduced neutrophil count
    Serum bilirubin increased


    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: June 2020

    Reference Sources

    Summary of Product Characteristics: Nubeqa 300mg tablets. Bayer plc. Revised May 2020.

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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.