Darolutamide oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of darolutamide.
Drugs List
Therapeutic Indications
Uses
Non-metastatic castration-resistant prostate cancer
Dosage
Adults
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.
Contraindications
Galactosaemia
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
Pregnancy
Not indicated for use in women.
Lactation
Not indicated for use in women.
Side Effects
Angina pectoris
Arterial occlusion
Arterial stenosis
Arteriosclerosis
Asthenia
Cardiac failure
Cardiogenic shock
Congestive cardiac failure
Coronary artery disorder
Fatigue
Fractures
Increase in AST level
Lethargy
Malaise
Musculoskeletal pain
Myocardial infarction
Myocardial ischaemia
Painful extremities
Rash
Reduced neutrophil count
Serum bilirubin increased
Overdosage
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 ).
Further Information
Last Full Review Date: June 2020
Reference Sources
Summary of Product Characteristics: Nubeqa 300mg tablets. Bayer plc. Revised May 2020.
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.