- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulation of osilodrostat.
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
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.
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: May 2021
Summary of product characteristics: Isturisa 1mg, 5mg, 10mg film coated tablets. Recordati Rare Diseases UK ltd. Revised May 2020.
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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.