What is darolutamide (NUBEQA®)?

Darolutamide is a hormonal therapy drug. It is also called  NUBEQA®. It is used to treat 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 the type of cancer you have.  

Your cancer team 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. They act as messengers and help control how cells and organs work. Hormonal therapy drugs change how hormones are made or 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.

How darolutamide is given

You have darolutamide as tablets you can take at home. You may have it with other cancer drugs.

During your treatment, you will meet someone from your cancer team, such as a:

  • cancer doctor
  • specialist nurse
  • specialist pharmacist.

This is who we mean when we mention doctor, nurse or pharmacist in this information.

Taking darolutamide tablets

Your cancer team will discuss your treatment plan with you. 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 they tell you to. 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, open, break or crush them 
  • take them at the same time every day.   

If you forget to take the tablets, take the missed dose as soon as possible within the same day. If a full day has passed, do not take a double dose.  

Other things to remember about your tablets:

  • Keep them in the original package and at room temperature, away from moisture, heat and direct sunlight.
  • Keep them safe, where children cannot see or reach them.
  • If you are sick (vomit) just after taking them, do not take an extra dose. Take your next dose at the usual time.
  • Get a new prescription before you run out, and make sure you have plenty for holidays.
  • Do not throw away unused tablets. Return them to a pharmacy. 

Your cancer team may also give you other medicines to take home. Take all your medicines exactly as they tell you to. 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.

Very common side effects

These side effects happen to 10 or more people in every 100 people (10% or more) who have this treatment.

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.

Low number of white blood cells

This treatment can reduce the number of white cells in your blood. These cells fight infection. If you have any signs of an infection, tell your doctor, nurse or pharmacist. These signs include:

  • a cough
  • a sore throat
  • diarrhoea
  • needing to pass urine (pee) often, or discomfort when you pass urine.

Contact the hospital straight away on the 24-hour number if you have any of these symptoms:

  • a temperature above 37.5°C 
  • a temperature below 36°C
  • you feel unwell, even with a normal temperature.

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.

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. Usually this side effect is mild, but for some people it can be more severe. If skin problems are difficult to cope with, your cancer team may suggest changing the dose or the treatment you are taking.

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.

Other side effects

These side effects happen to less than 10 in 100 people (less than 10%) who have this treatment. Some of them are much rarer than this but they are still important to know about. Rare means a side effect that happens to less than 1 in 1,000 people (less than 0.1%).

Bone thinning (osteoporosis)

Taking this treatment for several months or more can increase the risk of bone thinning. This is called osteoporosis. It can make you more likely to get a broken bone (fracture). 

You may have bone density scans to check your bone health before and during treatment. These scans can diagnose osteoporosis or osteopenia (low bone density) so that it can be monitored. If your scan shows osteoporosis, your doctor usually prescribes:

  • drugs to protect your bones called bisphosphonates
  • calcium and vitamin D supplements. 

Regular exercise where you support your body weight, like walking, running and dancing, can help look after your bones. This is called weight-bearing exercise. Other types of strength exercises are also helpful. If you have any bone thinning or the cancer is affecting your bones, get advice from your cancer team first. 

Eating a healthy diet and not smoking also helps take care of your bones.

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.

Fits or seizures

Rarely, some people have had a fit (seizure) while taking this treatment. If this happens, it is important to either:

  • contact the hospital straight away on the 24-hour number
  • go to the hospital straight away.

You should not drive yourself to hospital.

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

This treatment may contain lactose. If you have a lactose allergy or intolerance, ask your doctor, nurse or pharmacist for more information.

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: 

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.

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.

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

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

Date reviewed

Reviewed: 01 July 2024
|
Next review: 01 July 2027
Trusted Information Creator - Patient Information Forum
Trusted Information Creator - Patient Information Forum

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