This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Osilodrostat oral

Updated 2 Feb 2023 | Adrenocortical suppressants


Oral formulation of osilodrostat.

Drugs List

  • ISTURISA 10mg tablets
  • ISTURISA 1mg tablets
  • ISTURISA 5mg tablets
  • osilodrostat 10mg tablets
  • osilodrostat 1mg tablets
  • osilodrostat 5mg tablets
  • Therapeutic Indications


    Cushing's syndrome

    Treatment of endogenous Cushing's syndrome in adults.


    Dosage is determined by individual response and tolerability with the aim of achieving normal cortisol levels.


    Initial dose: 2mg twice daily.

    Usual maintenance dose: 2mg to 7mg twice daily.

    Maximum dose: 30mg twice daily.

    Dose can be gradually titrated by 1mg to 2mg increments.

    Dose increase should not occur more than once every 1 to 2 weeks.

    Patients with asian ancestry
    Initial dose: 1mg twice daily.

    Patients with Hepatic Impairment

    Patients with moderate hepatic impairment (Child-Pugh B)
    Initial dose: 1mg twice daily.

    Patients with severe hepatic impairment (Child-Pugh C)
    Initial dose: 1mg once daily in the evening. Titrate to 1mg twice daily.


    Children under 18 years
    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Patients over 65 years
    Cardiac disorder
    Electrolyte imbalance
    History of torsade de pointes
    Moderate hepatic impairment
    Moderate renal impairment

    Consider reducing initial dose in hepatic impairment
    Correct electrolyte disorders before treatment
    Advise patient that dizziness/fatigue may initially affect ability to drive
    Renal impairment: Consider alternative parameter to urinary free cortisol
    Treatment to be initiated and supervised by a specialist
    Exclude pregnancy prior to initiation of treatment
    Perform ECG before and during treatment
    Monitor cortisol levels every 1 to 2 weeks until stable adequate response
    Monitor serum electrolytes
    Advise patient to report signs of hypocortisolism
    Consider discontinuation if patient develops corticotroph tumour
    If hypocortisolism occurs, reduce dose and/or institute steroid therapy
    Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
    Suspend/review treatment if QTcF interval greater than 480 msec
    Female: Contraception required during and for 1 week after treatment
    Breastfeeding: Do not breastfeed during & for 1 week after treatment

    Additional monitoring is recommended during conditions which increase cortisol demand such as psychological or physical stress, or concomitant medications that affect osilodrostat exposure.

    It is recommended to use an additional barrier method of contraception if hormonal contraceptives other than oral combination of ethinylestradiol and levonorgestrel are used.

    Patients with symptoms of hypocortisolism should be monitored for hypotension, hyponatraemia, hyperkalaemia and/or hypoglycaemia.

    Pregnancy and Lactation


    Osilodrostat is contraindicated during pregnancy.

    The manufacturer does not recommend using osilodrostat during pregnancy. Animal studies have shown reproductive toxicity.


    Osilodrostat is contraindicated during breastfeeding.

    The manufacturer states that breastfeeding should be discontinued during treatment with osilodrostat and for at least one week after treatment. It is unknown whether osilodrostat or its metabolites are excreted in human milk and a risk to the newborn/infant cannot be excluded.

    Side Effects

    Abdominal pain
    Adrenal insufficiency
    Decreased appetite
    Elevated blood testosterone
    Increase of liver transaminases
    Increased blood corticotrophin
    Prolongation of QT interval

    Effects on Laboratory Tests

    It is recommended to use laboratory methods that do not exhibit significant cross-reactivity with cortisol precursors such as 11-deoxycortisol.


    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: May 2021

    Reference Sources

    Summary of product characteristics: Isturisa 1mg, 5mg, 10mg film coated tablets. Recordati Rare Diseases UK ltd. Revised May 2020.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

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

    FDB Logo

    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.