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Regorafenib (Stivarga)

Regorafenib is a targeted cancer drug. You might have it as a treatment for:

  • gastro intestinal stromal cancer (GIST) – a rare type of soft tissue sarcoma of the stomach or intestines
  • advanced cancer that started in the liver (primary liver cancer)

How regorafenib works

Regorafenib is a type of targeted cancer drug called a cancer growth blocker. It works in two ways. It stops:

  • signals that tell cancer cells to grow
  • cancer cells forming new blood vessels, which they need to be able to grow

How you have regorafenib

Regorafenib are tablets you take once a day. 

The usual dose is 4 tablets (160mg). But your doctor may change the dose. 

You take regorafenib at the same time, each day. You swallow the tablets whole with a drink of water and after a low fat meal. A low fat meal means less than 30% fat.

Some examples of a low fat meal includes:

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

Taking your tablets

You must take tablets according to the instructions your doctor or pharmacist gives you.

Speak to your pharmacist if you have problems swallowing the tablets.

Whether you have a full or an empty stomach can affect how much of a drug gets into your bloodstream.

You should take the right dose, no more or less.

Talk to your specialist or advice line before you stop taking a cancer drug.

When you have regorafenib

You usually take regorafenib every day, for 3 weeks. Then you have a week with no treatment. This 4 week period is called a cycle of treatment. 

Then you start the cycle again. 

Regorafenib may shrink the cancer or stop it growing for a time. You usually take regorafenib for as long as it is helping you and the side effects aren’t too bad. 

Tests

You have blood tests before and during your treatment. They check your levels of blood cells and other substances in the blood. They also check how well your liver and kidneys are working.

Side effects

We haven't listed all the side effects. It's very unlikely that you will have all of these side effects, but you might have some of them at the same time.

How often and how severe the side effects are can vary from person to person. They also depend on what other treatments you're having. For example, your side effects could be worse if you're also having other drugs or radiotherapy.

When to contact your team

Your doctor, nurse or pharmacist will go through the possible side effects. They will monitor you closely during treatment and check how you are at your appointments. Contact your advice line as soon as possible if:

  • you have severe side effects 
  • your side effects aren’t getting any better
  • your side effects are getting worse

Early treatment can help manage side effects better. 

Contact your doctor or nurse immediately if you have signs of infection, including a temperature above 37.5C or below 36C.

Common side effects

These side effects happen in more than 10 in 100 people (10%). You might have one or more of them. They include:

Increased risk of getting an infection

Increased risk of getting an infection is due to a drop in white blood cells. Symptoms include a change in temperature, aching muscles, headaches, feeling cold and shivery and generally unwell. You might have other symptoms depending on where the infection is.

Infections can sometimes be life threatening. You should contact your advice line urgently if you think you have an infection. 

Breathlessness and looking pale

You might be breathless and look pale due to a drop in red blood cells. This is called anaemia.

Bruising, bleeding gums or nosebleeds

This is due to a drop in the number of platelets in your blood. These blood cells help the blood to clot when we cut ourselves. 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)

Tiredness and weakness (fatigue) can happen during and after treatment - doing gentle exercises each day can keep your energy up. Don't push yourself, rest when you start to feel tired and ask others for help.

Soreness, redness and peeling on palms and soles of feet

The skin on your hands and feet may become sore, red, or may peel. You may also have tingling, numbness, pain and dryness. This is called hand-foot syndrome or palmar plantar syndrome.

Loss of appetite and weight loss

You might not feel like eating and may lose weight. It is important to eat as much as you can. Eating several small meals and snacks throughout the day can be easier to manage. You can talk to a dietitian if you are concerned about your appetite or weight loss. 

Diarrhoea

Contact your advice line if you have diarrhoea, such as if you've had 4 or more loose watery poos (stools) in 24 hours. Or if you can't drink to replace the lost fluid. Or if it carries on for more than 3 days.

Your doctor may give you anti diarrhoea medicine to take home with you after treatment. Eat less fibre, avoid raw fruits, fruit juice, cereals and vegetables, and drink plenty to replace the fluid lost.

Voice changes

Your voice might get husky or croaky and sound weaker. This can last for a while after your treatment.

High blood pressure

Tell your doctor or nurse if you have headaches, nose bleeds, blurred or double vision or shortness of breath. Your nurse will check your blood pressure regularly.

Mouth sores and ulcers

Mouth sores and ulcers can be painful. Keep your mouth and teeth clean; drink plenty of fluids; avoid acidic foods such as oranges, lemons and grapefruits; chew gum to keep the mouth moist and tell your doctor or nurse if you have ulcers.

Skin changes

Skin problems include a skin rash, dry skin and itching. This usually goes back to normal when your treatment finishes. Your nurse will tell you what products you can use on your skin to help.

Feeling or being sick

Feeling or being sick is usually well controlled with anti sickness medicines. Avoiding fatty or fried foods, eating small meals and snacks, drinking plenty of water, and relaxation techniques, can all help.

It is important to take anti sickness medicines as prescribed even if you don’t feel sick. It is easier to prevent sickness rather than treating it once it has started.

High levels of bilirubin

You might have high levels of bilirubin in your blood. You will have regular blood tests to check the bilirubin levels. 

Pain

You may have some pain in your joints, arms and legs, or back. Tell your doctor or nurse if you have any pain. They can give medicine to help.

High temperature (fever)

If you get a high temperature, let your treatment team know straight away. Ask them if you can take paracetamol to help lower your temperature.

Occasional side effects

These side effects happen in between 1 and 10 out of every 100 people (1 to 10%). You might have one or more of them. They include:

  • changes in levels of minerals in your blood
  • indigestion and heartburn
  • loss of body fluid (dehydration)
  • numbness or tingling in fingers or toes – this is often temporary and improves after treatment finishes
  • stiffness of your muscles and joints
  • flaky and peeling skin
  • taste changes
  • a dry mouth
  • a drop in thyroid hormone levels which can make you feel tired, unable to cope with the cold and you might get muscle cramps
  • shaking or tremors
  • loss of hair – this usually starts to grow back after you have stopped taking the drug
  • headaches
  • inflammation of your stomach or bowel
  • protein in urine

Rare side effects

These side effects happen in fewer than 1 in 100 people (1%). You might have one or more of them. They include:

  • a heart attack
  • changes to your nails – they can get weak, split or develop ridges
  • a severe skin reaction that may start as tender red patches which leads to peeling or blistering of the skin. You might also feel feverish and your eyes may be more sensitive to light. This is serious and could be life threatening
  • an allergic reaction that can cause rash, shortness of breath, redness or swelling of the face and dizziness
  • skin cancer (squamous cell carcinoma)
  • inflammation of the pancreas causing stomach pain and, feeling sick or being sick
  • a hole in the wall of your bowel or stomach

Coping with side effects

We have more information about side effects and tips on how to cope with them.

What else do I need to know?

Other medicines, foods and drink

Cancer drugs can interact with some other medicines and herbal products. Tell your doctor or pharmacist about any medicines you are taking. This includes vitamins, herbal supplements and over the counter remedies.

Grapefruit and grapefruit juice

You should not eat grapefruit or drink grapefruit juice when you are taking this drug because it can react with the drug.

Soya allergy

This drug contains soya. If you have an allergy to soya, contact your doctor before taking this medicine.

Pregnancy and contraception

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

Breastfeeding

Don’t breastfeed during this treatment because the drug may come through into your breast milk.

Loss of fertility

You may not be able to become pregnant or father a child after treatment with this drug. Talk to your doctor before starting treatment if you think you may want to have a baby in the future. Men may be able to store sperm before starting treatment. Women may be able to store eggs or ovarian tissue but this is rare.

Treatment for other conditions

Always tell other doctors, nurses or dentists that you’re having this drug if you need treatment for anything else, including teeth problems.

Slow wound healing

This drug can slow wound healing. If you need to have an operation you may need to stop taking it for a while beforehand. Your doctor will let you know when you can start taking it again.

Immunisations

Having immunisations 

Don’t have immunisations with live vaccines while you’re having treatment and for up to 12 months afterwards. The length of time depends on the treatment you are having. Ask your doctor or pharmacist how long you should avoid live vaccinations.

In the UK, live vaccines include rubella, mumps, measles, BCG, yellow fever and the shingles vaccine (Zostavax).

You can:

  • have other vaccines, but they might not give you as much protection as usual
  • have the flu vaccine (as an injection)

Contact with others who have had immunisations 

You can be in contact with other people who have had live vaccines as injections. Avoid close contact with people who have recently had live vaccines taken by mouth (oral vaccines) such as the oral typhoid vaccine.

If your immune system is severely weakened, you should avoid contact with children who have had the flu vaccine as a nasal spray. This is for 2 weeks following their vaccination.

Babies have the live rotavirus vaccine. The virus is in the baby’s poo for about 2 weeks and could make you ill if your immunity is low. Get someone else to change their nappies during this time if you can. If this isn't possible, wash your hands well after changing their nappy.

More information about this treatment

For further information about this treatment go to the electronic Medicines Compendium (eMC) website.

You can report any side effect you have to the Medicines Health and Regulatory Authority (MHRA) as part of their Yellow Card Scheme.

Information and help