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Apalutamide oral


Oral formulations of apalutamide.

Drugs List

  • apalutamide 60mg tablets
  • ERLEADA 60mg tablets
  • Therapeutic Indications


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

    Non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
    Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).



    240mg (four 60mg tablets) as a single daily dose.

    Additional Dosage Information

    Dose modifications
    Any grade 3 or higher toxicity, or intolerable adverse reaction
    Withhold dose until symptoms improve to grade 1 or lower, then resume at the same dose or a reduced dose of 180mg or 120mg daily.

    Missed dose
    If a dose is missed, take the prescribed dose as soon as possible on the same day, and return to the normal dosing schedule the next day. Extra tablets should not be taken the next day to make up a missed dose.


    Children under 18 years
    Brain neoplasm
    Cerebral metastases
    Cerebral trauma
    History of seizures
    Long QT syndrome
    Recent cerebrovascular accident
    Severe hepatic impairment
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Congestive cardiac failure
    Electrolyte imbalance
    History of torsade de pointes
    Pulmonary embolism
    Recent myocardial infarction
    Severe angina
    Severe renal impairment
    Unstable angina
    Ventricular arrhythmias

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Evaluate patient for fracture/fall risk before and during treatment
    Consider monitoring ECG in patients at risk of QT prolongation
    Discontinue treatment if patient develops seizures
    Monitor patients with cardiovascular disease
    Monitor serum electrolytes
    Interrupt treatment for any grade 3 toxicity
    May cause impaired fertility
    Male: Additional contraception required in addition to barrier method
    Male: Use barrier contraception during and for 3 months after treatment

    Medical castration (with gonadotropin releasing hormone analogue) should be continued throughout treatment with apalutamide in patients not surgically castrated.

    Pregnancy and Lactation


    Apalutamide is not indicated for use in women.

    There is a theoretical risk of foetal harm when apalutamide is administered during pregnancy. There is no human or animal data available on apalutamide use during pregnancy.


    Apalutamide is not indicated for use in women.

    A risk to the nursing infant cannot be excluded.

    Side Effects

    Decreased appetite
    Prolongation of QT interval
    Toxic epidermal necrolysis
    Weight loss


    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: February 2021

    Reference Sources

    Summary of Product Characteristics: Erleada film-coated tablets. Janssen-Cilag Ltd. Revised November 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.