darolutamide at a glance
Medicine class
Non-steroidal androgen receptor inhibitor
Main role
Treatment of specified non-metastatic castration-resistant or metastatic hormone-sensitive prostate cancer
Administration
Swallow the tablets whole with food
Treatment oversight
Started and supervised by a prostate-cancer specialist
What is darolutamide used for?
UK-licensed uses in adult men are:
Non-metastatic castration-resistant prostate cancer with a high risk of developing metastatic disease.
Metastatic hormone-sensitive prostate cancer with androgen deprivation therapy.
Metastatic hormone-sensitive prostate cancer with docetaxel.
How does darolutamide work?
Androgens such as testosterone can encourage prostate-cancer cells to grow. Darolutamide blocks androgen binding to its receptor, movement of the receptor into the cell nucleus and activation of androgen-responsive genes.
darolutamide preparations and strengths
Tablet
Route: Oral
Strengths: 300 mg
How to take darolutamide
Follow the specialist team's instructions.
Swallow tablets whole with food.
Do not crush or split them unless the specialist team confirms an appropriate alternative.
Tell the team if swallowing tablets becomes difficult.
darolutamide side effects
Common or expected effects
- Tiredness, weakness or lethargy
- Rash
- Pain in an arm or leg
- Fractures
- Changes in liver enzymes, bilirubin, haemoglobin or neutrophil count
- Ischaemic heart disease or heart failure
- With docetaxel: rash, raised blood pressure and liver-test changes
Get urgent medical advice
- Swelling of the face, lips, tongue or throat
- Chest pain, breathlessness or other symptoms of ischaemic heart disease or heart failure
- A seizure
- Yellow skin or eyes, dark urine or severe abdominal pain
- Fever or signs of infection, particularly when receiving docetaxel
darolutamide in pregnancy
Darolutamide is contraindicated in women who are or may become pregnant and may harm a fetus. A man whose partner could become pregnant should use highly effective contraception during treatment and for one week afterwards; a condom is required during this period if the partner is pregnant. Seek specialist advice if pregnancy occurs or is suspected.
darolutamide while breastfeeding
Darolutamide is not for use while breastfeeding. It is unknown whether it passes into human milk, and risk to a breastfed child cannot be excluded.
darolutamide interactions
Review prescription, non-prescription and herbal products before treatment. Important examples include:
Rifampicin, carbamazepine, phenobarbital, phenytoin and St John's wort
These can substantially reduce darolutamide exposure, so alternatives should be considered.
Rosuvastatin
Darolutamide can markedly increase rosuvastatin exposure; concurrent use should generally be avoided unless no suitable alternative exists.
Atorvastatin, fluvastatin, pitavastatin, methotrexate and sulfasalazine
Darolutamide may increase their concentrations, requiring adverse-effect monitoring.
Common questions about darolutamide
Answers are fully visible for fast scanning and source review.
Is darolutamide chemotherapy?
No. It is an androgen receptor inhibitor, although it may be prescribed alongside docetaxel.
Why must the tablets be taken with food?
Food substantially increases absorption and helps produce more reliable exposure.
Can the tablets be crushed?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.