Darolutamide

Darolutamide is also known as NUBEQA®. It is used to treat prostate cancer that has stopped responding to other types of hormonal therapy but has not yet spread to other parts of the body.

What is darolutamide (NUBEQA®)?

Darolutamide (NUBEQA®) is a hormonal therapy drug used to treat prostate cancer. It is used when treatment has stopped responding to other types of hormonal therapy but has not yet spread to other parts of the body. This is called non-metastatic castrate-resistant prostate cancer.

You usually take darolutamide with your existing hormonal therapy.

It is best to read this information with our general information about hormonal therapies and prostate cancer.

Your doctor will talk to you about this treatment and its possible side effects before you agree (consent) to have treatment.

More information about this treatment

This information is correct at time of publishing. But sometimes the types of cancer this treatment is used for, or treatment side effects, may change between revision dates.

You can talk to your cancer team if you want more detailed information about this treatment. Or visit the electronic Medicines Compendium (eMC) website, which has patient information leaflets (PIL) for individual drugs.

How darolutamide works

Hormones are chemicals that our bodies make. Hormones act as messengers and help control how cells and organs work. Hormonal therapies are drugs that change the way hormones are made or how they work in the body.

Darolutamide aims to slow the spread of prostate cancer to other parts of the body. Prostate cancer cells need the hormone testosterone to grow and spread. Darolutamide blocks the action of testosterone on prostate cancer cells. This stops the cells from growing and dividing.

Taking darolutamide tablets

Darolutamide comes as tablets you can take at home. Your nurse or doctor will talk to you about your treatment plan. They may give you a copy of a treatment plan to take home with you.

During treatment you will regularly see a cancer doctor, a cancer nurse or specialist nurse, and a specialist pharmacist. This is who we mean when we mention doctor, nurse or pharmacist in this information. They will ask you how you are feeling. Your nurse may check your weight and blood pressure.

During treatment, a nurse or person trained to take blood called a phlebotomist will regularly take blood samples from you. This is to check your general health and that your blood cells are at a safe level to have treatment. You will also have regular PSA tests.

The usual dose of darolutamide is 600mg (2 tablets of 300mg) taken 2 times a day. The dose may be reduced for a while if you have a side effect. Always take the tablets exactly as explained. This is important to make sure they work as well as possible for you.

Make sure you:

  • take the tablets with food
  • swallow them whole with a glass of water
  • do not chew, break or crush the tablets
  • take them at the same time every day

If you forget to take the tablets, you should take the missed dose as soon as you remember before the next dose is due. Do not take a double dose to make up for the forgotten one.

Other things to remember about your tablets:

  • Keep them in the original package and at room temperature, away from heat and direct sunlight.
  • Keep them safe and out of sight and reach of children.
  • If you are sick just after taking the tablets, contact your healthcare team. Do not take another dose.
  • Get a new prescription before you run out of tablets, and make sure you have plenty for holidays.
  • If your treatment is stopped, return any unused tablets to the pharmacist.

Do not stop taking any of your medicines unless your doctor tells you to.

About side effects

We explain the most common side effects of this treatment here. We also include some that are less common.

You may get some of the side effects we mention, but you are unlikely to get all of them. And you may have some side effects, including rarer ones, that we have not listed here. 

Other cancer treatments may cause different side effects. If you are also having other cancer treatment, you may have other side effects.

When you have this treatment, you will have regular appointments with a doctor, nurse or pharmacist. Always tell them about any side effects you have. They can give you: 

  • drugs to help control most side effects 
  • advice about managing side effects. 

Most side effects can be managed. But sometimes side effects are harder to control. It is important not to stop taking hormonal therapy without telling your doctor. If side effects cannot be managed, your doctor may suggest a different type of hormonal therapy.

Serious and life-threatening side effects

Some cancer treatments can cause serious side effects. Sometimes, these may be life-threatening. Your doctor, nurse or pharmacist can explain the risk of these side effects to you.

Contact the hospital

Your doctor, nurse or pharmacist will give you 24-hour contact numbers for the hospital. If you feel unwell or need advice, you can call at any time of the day or night. Save these numbers in your phone or keep them somewhere safe.

Common side effects

Feeling tired (fatigue)

Feeling tired is a common side effect. Try to pace yourself and plan your day so you have time to rest between activities.

Being physically active can help to manage tiredness and give you more energy. It also:

  • helps you sleep better
  • reduces stress
  • improves your bone health.

If you feel sleepy, do not drive or operate machinery.

Muscle or joint pain

You may get pain in your muscles or joints. If this happens, tell your doctor or nurse. They can give you advice and painkillers or other drugs to help. Being physically active and keeping to a healthy weight may help with the pain. It can keep your joints flexible and reduce stress on them. If the pain does not get better, tell your doctor or nurse. They may talk to you about changing to a different hormonal drug.

Skin changes

This treatment can affect your skin. It may cause a rash, which may be itchy. Your doctor or nurse can tell you what to expect. If your skin feels dry, try using soap-free cleansers and unperfumed moisturising cream every day. 

Always tell your doctor or nurse about any skin changes. They can give you advice and may prescribe creams or medicines to help. Changes to your skin usually improve when treatment ends.

Low number of white blood cells

This treatment can reduce the number of white cells in your blood. This is usually mild. These cells fight infection. Tell your doctor or nurse if you have any signs of an infection. These include:

  • a cough
  • a sore throat
  • diarrhoea
  • needing to pass urine (pee) often.

Contact your doctor or the hospital straight away if:

  • your temperature goes over 37.5°C (99.5°F)
  • you suddenly feel unwell, even with a normal temperature.

Risk of fracture

Darolutamide can increase your risk of a broken bone (fracture). You may have bone density scans to check your bone health before and during treatment.

Doing regular exercise, such as walking, can improve your bone health. Eating a healthy diet can help too. Your doctor may prescribe drugs called bisphosphonates to help protect your bones. They may also advise you to take calcium and vitamin D supplements.

Effects on the heart

This treatment might increase certain risk factors for heart problems. Tell your doctor if you have:

  • had any problems with your heart
  • high blood pressure
  • high levels of cholesterol – a fatty substance in your blood. 

They can monitor or treat these if needed. Talk to your doctor if you are worried about this. 

Things you can do to take care of your heart include:

  • not smoking
  • maintaining a healthy weight 
  • being physically active.

Effects on the liver

This treatment may affect how your liver works. This is usually mild. You will have blood tests to check how well your liver is working.

Other information

Blood clot risk

Cancer and some cancer treatments can increase the risk of a blood clot. Contact the hospital straight away on the 24-hour number if you have any of these symptoms during or after treatment:

  • throbbing pain or swelling in a leg or arm
  • reddening of the skin in the area – if you have black or brown skin, this can be harder to notice, but the skin might become darker
  • suddenly feeling breathless or coughing.

Always call 999 if you have:

  • chest pain
  • difficulty breathing.

A blood clot is serious, but it can be treated with drugs called anticoagulants. These thin the blood. Your doctor, nurse or pharmacist can give you more information about preventing and treating blood clots.

Lactose

These tablets contain lactose. Tell your doctor if you have an allergy to lactose.

Other medicines

Some medicines can affect how this treatment works or be harmful while you are having it. Always tell your cancer doctor, nurse or pharmacist about any drugs you are taking or planning to take, such as: 

Fertility

Some cancer drugs can affect whether you can get pregnant or make someone pregnant. If you are worried about this, it is important to talk with your doctor before you start treatment.

Contraception

Your doctor will advise you not to make someone pregnant while having this treatment. The drugs may harm a developing baby.

During your treatment and for a week after you stop taking darolutamide, it is important to use:

  • contraception to prevent pregnancy
  • a condom if your partner is already pregnant.

Your doctor, nurse or pharmacist can tell you more about this.

Medical and dental treatment

If you need medical treatment for any reason other than cancer, always tell the healthcare professional that you are having cancer treatment. Give them the contact details for your cancer doctor or cancer team so they can ask for advice.

If you have appointments with a dentist, always tell them you are having cancer treatment. Talk to your cancer team before you have any dental treatment.

About our information

  • Reviewers

    This information has been written, revised and edited by Macmillan Cancer Support’s Cancer Information Development team. It has been reviewed by expert health professionals and people living with cancer.

    Our cancer information has been awarded the PIF TICK. Created by the Patient Information Forum, this quality mark shows we meet PIF’s 10 criteria for trustworthy health information.

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We use gender-inclusive language and talk to our readers as ‘you’ so that everyone feels included. Where clinically necessary we use the terms ‘men’ and ‘women’ or ‘male’ and ‘female’. For example, we do so when talking about parts of the body or mentioning statistics or research about who is affected.

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Date reviewed

Reviewed: 01 September 2022
|
Next review: 01 June 2024

This content is currently being reviewed. New information will be coming soon.

Trusted Information Creator - Patient Information Forum
Trusted Information Creator - Patient Information Forum

Our cancer information meets the PIF TICK quality mark.

This means it is easy to use, up-to-date and based on the latest evidence. Learn more about how we produce our information.