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Patient information - Prostate cancer - darolutamide

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This information sheet outlines your treatment. It should be reviewed together with your doctor, nurse or pharmacist to address any questions or concerns.

The treatment schedule below explains when you will receive the medicines and how they are given.  Your doctor, nurse or pharmacist will be able to explain how your treatment works in more detail.

It is important to understand that darolutamide is not a traditional chemotherapy drug and has a different way of working. It works by blocking hormones which stops the cancer cells growing and spreading. Read more about androgen deprivation therapy for prostate cancer. This treatment may be used to treat different types of prostate cancer. Your doctor will advise you why you are receiving this treatment.

The treatment schedule below explains how the drug for this treatment is given. 

Darolutamide
This treatment is continuous. Your doctor will advise you how long to take the treatment for.
Day Treatment How it is given
Continuous Darolutamide (dar-oh-LOO-ta-mide )

Take orally TWICE a day, with a glass of water, with or after food. Swallow tablets whole, do not break, crush or chew.

If you miss a dose, take this as soon as possible (only if it is on the same day). If it is almost time for you to take your next dose, skip the dose that you missed and just take the next one. Do NOT take a double dose to make up the dose missed.

Anticancer drugs (drugs used to treat cancer) can sometimes cause serious problems. It is important to get medical help immediately if you suddenly become unwell.

Emergency

IMMEDIATELY go to your nearest hospital Emergency Department, or contact your doctor or nurse if you develop any chest pain or changes in the way your heart beats (e.g. if it is beating faster) or any seizures.

Emergency contact details

Ask your doctor or nurse from your treating team who to contact if you have a problem
Daytime: 
Night/weekend: 
Other instructions: 
 

Changes to your dose or treatment delays

Sometimes a treatment may be started at a lower dose or the dose needs to be changed during treatment. There may also be times when your treatment is delayed. This can happen if your doctor thinks you are likely to have severe side effects, if you get severe side effects, if your blood counts are affected and causing delays in treatment, or if you are finding it hard to cope with the treatment. This is called a dose reduction, dose change or treatment delay. Your doctor will explain if you need any changes or delays to your treatment and the reason why.

Blood tests and monitoring 

You may need to have blood tests while you are receiving this treatment. Your doctor or nurse will tell you when to have these blood tests.

Androgen deprivation therapy (ADT)

For more information see the eviQ patient information sheet on Androgen deprivation therapy (ADT) for prostate cancer. 

Cancer treatments can cause damage to normal cells in your body, which can cause side effects. Everyone gets different side effects, and some people will have more problems than others.

The table below shows some of the side effects you may get with this treatment. You are unlikely to get all of those listed and you may also get some side effects that have not been listed.

Tell your doctor or nurse about any side effects that worry you. Follow the instructions below and those given to you by your doctor or nurse.

Early (onset days to weeks)

Tiredness and lack of energy (fatigue)

  • You may feel very tired, have no energy, sleep a lot, and not be able to do normal activities or things you enjoy.
  • Do not drive or operate machinery if you are feeling tired.
  • Nap for short periods (only 1 hour at a time)
  • Prioritise your tasks to ensure the best use of your energy.
  • Eat a well balanced diet and drink plenty of fluids (unless you are fluid restricted).
  • Try some gentle exercise daily.
  • Allow your friends and family to help.
  • Tell your doctor or nurse if you get any of the symptoms listed above.

Diarrhoea

  • You may get bowel motions (stools, poo) that are more frequent or more liquid.
  • You may also get bloating, cramping or pain.
  • Take your antidiarrhoeal medication as directed by your doctor.
  • Drink plenty of fluids (unless you are fluid restricted).
  • Eat and drink small amounts more often.
  • Avoid spicy foods, dairy products, high fibre foods, and coffee.
  • Ask your doctor or nurse for eviQ patient information - Diarrhoea during cancer treatment. 
  • Tell your doctor or nurse immediately, or go to your nearest hospital Emergency Department if your diarrhoea is not controlled, you have 4 or more loose bowel motions per day, and if you feel dizzy or light-headed.

High blood pressure (hypertension)

  • You may not have any signs or symptoms if you have high blood pressure. 
  • If it is severe you may get headaches, shortness of breath or feel dizzy. 
  • Your blood pressure will be taken regularly during your treatment.
  • Tell your doctor or nurse immediately, or go to the nearest hospital Emergency Department if you get any of the signs or symptoms listed above. 

Skin rash

  • You may get a red, bumpy rash and dry, itchy skin. 
  • Moisturise your skin with a gentle non-perfumed moisturising cream like sorbolene or aqueous cream.
  • Do not scratch your skin.
  • Protect your skin from the sun by wearing sun-protective clothing, a wide-brimmed hat, sunglasses and sunscreen of SPF 50 or higher.
  • Talk to your doctor or nurse about other ways to manage your skin rash.

Hot flushes

  • You may get flushing of your face, sweating and sensations of heat.
  • Avoid alcohol, coffee, tea and spicy foods, as they can make hot flushes worse.
  • Wear lightweight clothes made from natural fibres; dress in layers.
  • Put a cold, wet towel against your neck during hot flushes.
  • Talk to your doctor or nurse about other ways to manage these symptoms.

Liver problems

  • You may get: 
    • yellowing of your skin or eyes
    • itchy skin 
    • pain or tenderness in your stomach
    • nausea and vomiting
    •  loss of appetite
  • You will have regular blood tests to check how well your liver is working.
  • Tell your doctor or nurse as soon as possible if you notice that your urine is a dark colour, the whites of your eyes look yellow, or if you have stomach pain.

Joint and muscle pain and stiffness

  • You may get muscle, joint or general body pain and stiffness.
  • Applying a heat pack to affected areas may help.
  • Talk to your doctor or nurse about other ways to manage these symptoms. You may need medication to help with any pain.

Nausea and vomiting

  • You may feel sick (nausea) or be sick (vomit).
  • Drink plenty of fluids (unless you are fluid restricted).
  • Eat small meals more frequently.
  • Try food that does not require much preparation.
  • Try bland foods like dry biscuits or toast.
  • Gentle exercise may help with nausea.
  • Anti-sickness medication is usually not needed but may help in some people.
  • Ask your doctor or nurse for eviQ patient information - Nausea and vomiting during cancer treatment. 
  • Tell your doctor or nurse immediately, or go to the nearest hospital Emergency Department if you have uncontrolled vomiting or feel dizzy or light-headed.

Late (onset weeks to months)

Heart problems

  • You may get:
    • chest pain or tightness
    • shortness of breath 
    • swelling of your ankles 
    •  an abnormal heartbeat.
  • Heart problems can occur months to years after treatment.
  • Tell your doctor if you have a history of heart problems or high blood pressure.
  • Before or during treatment, you may be asked to have a test to see how well your heart is working.
  • Tell your doctor or nurse immediately, or go to the nearest hospital Emergency Department if you get any of the symptoms listed above.

Blood clot risk

  • Cancer and anticancer drugs can increase the risk of a blood clot (thrombosis).
  • Tell your doctor if you have a family history of blood clots.
  • A blood clot can cause pain, redness, swelling in your arms or legs, shortness of breath or chest pain.
  • If you have any of these symptoms go to your nearest hospital Emergency Department.

Medications and vaccinations 

  • Before you start treatment, tell your doctor and pharmacist about any medications you are taking, including over-the-counter products, vitamins or herbal supplements.
  • Don’t stop or start any medications during treatment without talking to your doctor and pharmacist first.
  • Do not have any vaccinations without discussing with the doctor who is managing your cancer treatment.
  • People you live with should be fully vaccinated, according to the current vaccination schedule. Extra care needs to be taken with hand washing and careful disposal of soiled nappies for infants who have recently received the rotavirus vaccine.

Other medical and dental treatment

  • If you go to hospital or any other medical appointment (including dental appointments), always tell the person treating you that you are receiving anticancer drugs.
  • Before you have any dental treatment, talk to your doctor. 

Diet 

  • While you are receiving this treatment it is important that you try to maintain a healthy diet.
  • Speak to your doctor or nurse about whether drinking alcohol is safe with your treatment.
  • If you have any concerns about recent weight loss or weight gain or questions about your diet, ask to speak to a dietitian.
  • Avoid drinking or cooking with untreated water (e.g. water from rainwater tanks, bores or rivers) due to risk of contamination. If you intend to drink or cook with rainwater, you should bring it to a boil and allow the water to cool down before drinking or cooking with it. For more information see the NSW Health - Rainwater tanks opens in a new tab or window webpage.

Fertility

  • Some cancer treatments can reduce your fertility. This can make it difficult or impossible to father a child.
  • Talk to your doctor or nurse before you start any treatment. Depending on your situation there may be fertility sparing options available to you and/or your partner, discuss these with your doctor or nurse. 

Fathering a child

  • Some cancer treatments can be dangerous to unborn babies. Talk to your doctor or nurse if you think there is any chance that your partner could be pregnant.
  • Do not try to father a child during this treatment. Contraception should be used during treatment and after stopping treatment. Ask your doctor or nurse about what type of contraception you should use.
  • If you are planning fatherhood after completing this treatment, talk to your doctor. Some doctors advise waiting between 6 months and 2 years after treatment.

Sex life and sexuality 

  • The desire to have sex may decrease as a result of this treatment or its side effects. 
  • Your emotions and the way you feel about yourself may also be affected by this treatment. 
  • It may help to discuss your concerns with your partner and doctor or nurse.

Quitting smoking

  • It is never too late to quit smoking. Quitting smoking is one of the best things you can do to help your treatment work better.
  • There are many effective tools to improve your chances of quitting.
  • Talk to your treating team for more information and referral to a smoking cessation support service.

Staying active

  • Research shows that exercise, no matter how small, has many benefits for people during and after cancer treatment.
  • Talk to your doctor before starting an exercise program. Your doctor can advise whether you need a modified exercise program.

For more information about cancer treatment, side effects and side effect management see our Patient and carers section. 

Telephone support

  • Call Cancer Council on 13 11 20 for cancer information and support

Prostate cancer information

General cancer information and support

Quit smoking information and support

Quitting smoking is helpful even after you have been diagnosed with cancer. The following resources provide useful information and support to help you quit smoking. Talk to your treating team about any other questions you may have.

This document is a guide only and cannot cover every possible situation. Your treating team will consider your individual situation when making decisions about your care. Contact your doctor, nurse, pharmacist, or radiation therapist if you have any questions or concerns about your treatment, or you are having problems coping with side effects. While eviQ aims to provide reliable information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use of this document is subject to eviQ’s disclaimer available at www.eviQ.org.au

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https://www.eviq.org.au/pi/4319

09 Jun 2025