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Regorafenib (Stivarga)

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This page tells you about the cancer drug regorafenib (pronounced reg-or-aff-eh-nib). There are sections on


What regorafenib is

Regorafenib is also called by its brand name Stivarga. It is a treatment for

  • Bowel cancer that has spread to other parts of the body – when other treatments are no longer working or are unsuitable
  • Gastro intestinal stromal cancer (GIST) – a rare type of soft tissue sarcoma of the stomach or intestines. This treatment is used when other treatments are no longer working or are unsuitable

You may have it as part of clinical trials for other types of cancer.


How regorafenib works

Regorafenib works by blocking particular proteins on cancer cells that encourage the cancer to grow. These proteins are called protein kinases. Regorafenib is called a protein tyrosine kinase inhibitor (TKI) or cancer growth blocker.

Regorafenib stops a number of different proteins being made and is called a multi kinase inhibitor. It works by stopping signals that tell cancer cells to grow. It also stops the cancer cells growing blood vessels that they need. Blocking blood vessel growth is called anti angiogenesis treatment.

Regorafenib may shrink the cancer or stop it growing for a time.


How you have regorafenib

Regorafenib comes as tablets. The usual dose is 4 tablets. You take them once a day. Your doctor may change the dose.

You take regorafenib for 3 weeks and then you stop for 1 week. This is one cycle of treatment. Then the cycle starts again. You usually carry on taking regorafenib for as long as it works.  

You should take regorafenib at the same time each day after a low fat meal.

An example of a low fat meal would include

  • 1 portion of cereal (about 30 g)
  • 1 glass of skimmed milk
  • 1 slice of toast with jam
  • 1 glass of apple juice
  • 1 cup of coffee or tea

Total = 520 calories and 2 g fat

Swallow the tablets whole with a drink of water. It is very important that you take the tablets according to the instructions your doctor or pharmacist gives you. For example, if you don’t have regorafenib with a low fat meal it can change how much of the drug gets into your bloodstream. Check the pack leaflet and follow the instructions it gives.

Take the right dose, not more or less. And never stop taking a cancer drug without talking to your specialist first.


Common side effects

More than 10 in every 100 people have one or more of these side effects.

  • Tiredness and breathlessness from a drop in red blood cells (anaemia). You may need a blood transfusion
  • Bruising more easily from a drop in platelets. You may have nosebleeds or bleeding gums after brushing your teeth. Or you may have lots of tiny red spots or bruises on your arms or legs (known as petechia)
  • Tiredness and weakness (fatigue) happens in half of people (50%)
  • Soreness, redness and peeling on the palms of the hands and soles of the feet (palmar–plantar syndrome) happens in almost half of people (50%). This may cause tingling, numbness, pain and dryness
  • Headaches – taking paracetamol can help
  • Loss of appetite affects 3 out of 10 people (30%)
  • Diarrhoea occurs in just over 3 out of 10 people (30%). Drink plenty of fluids and tell your doctor or nurse if you are worried about how bad it is, or if it continues for more than 3 days
  • A hoarse voice or voice changes happen in 3 in 10 people (30%)
  • Your blood pressure may be higher than normal – this happens in about 3 in 10 people (30%)
  • A sore mouth affects 3 out of 10 people (30%)
  • Skin changes occur in about 1 out of 4 people (25%). You may have a rash or red, dry, itchy skin
  • Feeling or being sick affects just over 1 out of every 10 people (10%). This is usually well controlled with anti sickness medicines
  • Higher levels of bilirubin in your blood – you will have regular blood tests to check your bilirubin levels
  • Hair thinning
  • Weight loss
  • Pain

Occasional side effects

Between 1 and 10 in every 100 people have one or more of these side effects.

  • An increased risk of getting an infection from a drop in white blood cells – it is harder to fight infections and you can become very ill. You may have headaches, aching muscles, a cough, a sore throat, pain passing urine, or you may feel cold and shivery. If you have a severe infection this can be life threatening. Contact your treatment centre straight away if you have any of these effects or if your temperature goes above 38°C. You will have regular blood tests to check your blood cell levels
  • Low levels of potassium, magnesium, calcium and phosphate in your blood – you will have blood tests to check the levels
  • Indigestion or heartburn (dyspepsia)
  • High uric acid levels in the blood due to the breakdown of tumour cells (tumour lysis syndrome). You will have regular blood tests to check your uric acid levels. You may also have a tablet called allopurinol to take. Drinking plenty of fluids helps to flush out the excess uric acid
  • Dry skin and a rash with flaking or peeling skin
  • Muscle or joint stiffness
  • Mild effects on the liver and kidneys which are unlikely to cause any symptoms. These usually go back to normal after the treatment ends. You will have regular blood tests to check how your liver and kidneys are working
  • Taste changes or loss of taste
  • A drop in the level of thyroid hormones (hypothyroidism) – you may feel tired or cold, or your voice may deepen. You will have regular blood tests to check your thyroid hormone levels
  • Shaking (tremor)

Rare side effects

Fewer than 1 in 100 people have these side effects.

  • Heart problems that can cause chest pain or a heart attack
  • High blood pressure with headaches, confusion, loss of eyesight and fits (seizures) – let your doctor or nurse know if you have these
  • Nail changes, including ridging and splitting
  • Serious blistering and reddening of the skin and insides of your mouth and bowel. Let your doctor know if you notice any skin changes or bowel pain
  • New skin cancers, including squamous cell cancers – let your doctor know if you notice any skin changes

Important points to remember

You may have a few of the side effects listed on this page. They may be mild or more severe. A side effect may get better or worse through your course of treatment. Or you may have more side effects as the course goes on. This depends on

  • How many times you've had a drug before
  • Your general health
  • How much of the drug you have (the dose)
  • Other drugs you are having

Coping with side effects

Talk to your doctor, pharmacist or nurse about all your side effects so that they can help you manage them. They can give you advice or reassure you. Your nurse will give you a contact number to ring if you have any questions or problems. If in doubt, call them.

Other medicines

Tell your doctor about any other medicines you are taking, including vitamins, herbal supplements and over the counter remedies. Some drugs can react together.

Pregnancy and contraception

This drug may harm a baby developing in the womb. It is important not to become pregnant or father a child while you are having treatment and for a few months afterwards. Talk to your doctor or nurse about effective contraception before starting treatment.


Do not breastfeed during this treatment because the drug may come through in the breast milk.

Slow wound healing

Regorafenib can make wounds heal more slowly. If you need to have an operation you may need to stop taking regorafenib for a while beforehand. Your treatment team will let you know when you can start taking it again.



You should not have immunisations with live vaccines while you are having this treatment or for at least 6 months afterwards. In the UK, these include rubella, mumps, measles (usually given together as MMR), BCG, yellow fever and Zostavax (shingles vaccine).

You can have other vaccines, but they may not give you as much protection as usual until your immune system has fully recovered from your treatment. It is safe to have the flu vaccine.

It is safe for you to be in contact with other people who've had live vaccines as injections. There can be problems with vaccines you take by mouth (oral vaccines), but not many people in the UK have these now. So there is usually no problem in being with any baby or child who has recently had any vaccination in the UK. You might need to make sure that you aren't in contact with anyone who has had oral polio, cholera or typhoid vaccination recently, particularly if you live abroad.


Related information


More information about regorafenib

We don’t list all the very rare side effects of this treatment that are very unlikely to affect you. For further information look at the Electronic Medicines Compendium website at

If you have a side effect we don’t list here and you think it may be due to this treatment, you can report it to the Medicines Health and Regulatory Authority (MHRA). Go to

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Updated: 14 April 2015