Indications
Darolutamide is used to treat prostate cancer in adult men. It is used for prostate cancer that has not spread but no longer responds well to hormone (testosterone-lowering) treatment alone and is at high risk of spreading, and, together with hormone treatment (with or without Docetaxel chemotherapy), for prostate cancer that has spread and still responds to hormone treatment.
How It Works
Prostate cancer cells usually need male hormones (androgens) such as testosterone to grow. Darolutamide is an androgen receptor inhibitor: it blocks the receptor that androgens attach to, stops the receptor moving into the cell nucleus and prevents it switching on growth genes. This slows or stops the growth of the cancer. It is usually combined with medicine or surgery that lowers testosterone.
Dosage and Administration
Take exactly as prescribed by your cancer specialist. It is taken by mouth twice a day with food, swallowing the tablets whole. Your testosterone-lowering treatment normally continues at the same time. The doctor may reduce the dose or pause treatment if side effects occur. If you miss a dose, take it as soon as you remember before the next dose, but never take two doses together.
Interactions
- Strong enzyme inducers such as Rifampicin, Carbamazepine, Phenytoin and St John’s wort can lower its levels and should be avoided.
- Darolutamide raises blood levels of Rosuvastatin and some other statins; the statin dose may need adjusting.
- Medicines that affect heart rhythm should be reviewed, as hormone treatment can affect the heart.
- Tell your doctor about all medicines, supplements and herbal products.
Contraindications
- Allergy to Darolutamide or any ingredient.
- Women, especially those who are or may become pregnant (it is not for use in women).
Side Effects
Common side effects include tiredness, pain in the arms and legs, rash, and changes in liver tests and blood counts. Heart problems such as irregular heartbeat, heart failure or heart attack have been reported in men having this type of treatment. Hormone therapy overall can cause hot flushes, weakening of the bones and reduced sex drive.
Get urgent medical help if you have chest pain or pressure, shortness of breath, fainting, a fast or irregular heartbeat, sudden weakness or numbness on one side of the body, yellowing of the skin or eyes with dark urine, or a severe rash.
Pregnancy and Lactation
Darolutamide is not used in women. It may harm an unborn baby. Men whose partner could become pregnant should use a condom plus another effective form of contraception during treatment and for 1 week after the last dose, and should not donate sperm during this time.
Precautions and Warnings
- Tell your doctor if you have heart disease, high blood pressure, diabetes or high cholesterol; these will be monitored and treated.
- Use with care in severe liver or kidney disease.
- Regular blood tests and check-ups are needed.
- Ask about exercise, calcium and vitamin D to protect bone health during hormone therapy.
Overdose
There is limited experience of overdose. If more than the prescribed dose has been taken, contact your doctor or the nearest hospital straight away.
Therapeutic Class
Antineoplastic hormone therapy, androgen receptor inhibitor (anti-androgen).
Storage
Store below 30°C in a dry place, away from light and out of the reach of children. Return unused tablets to a pharmacy for safe disposal.
Prepared by the Oshud Alo team from standard drug references. For information only; always follow your doctor's advice.