Regorafenib

Regorafenib is a targeted cancer drug . You pronounce regorafenib as re-gor-af-e-nib. It is also known as Stivarga.

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 )
• advanced bowel cancer that has been previously treated and there is no other available treatment

How does regorafenib work?

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 do you have regorafenib?

Regorafenib are tablets you take once a day. 

The usual dose is 4 tablets. But your doctor may change the dose. 

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

Examples of a low fat meal are:

• 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

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 healthcare team before you stop taking a cancer drug or if you miss a dose.

How often do 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.

What are the side effects of regorafenib?

Side effects can vary from person to person. They also depend on what other treatments you're having. 

When to contact your team

Your doctor, nurse or pharmacist will go through the possible side effects. They will monitor you 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. 

We haven't listed all the side effects here. Remember it is very unlikely that you will have all of these side effects. But you might have some of them at the same time.

Common side effects

These side effects happen in more than 10 in 100 people (more than 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 petechiae).

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.

Moisturise your skin regularly. Your healthcare team will tell you what moisturiser to use.

Loss of appetite and weight loss

You might not feel like eating and may lose weight. 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 or constipation

Tell your healthcare team if you have diarrhoea or constipation. They can give you medicine to help. 

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, nosebleeds, blurred or double vision or shortness of breath. You have your blood pressure checked regularly.

A less common side effect you might have is a sudden, severe increase in blood pressure.

Mouth sores and ulcers

Mouth sores and ulcers can be painful. It helps to keep your mouth and teeth clean, drink plenty of fluids and avoid acidic foods such as lemons. Chewing gum can help to keep your mouth moist. Tell your doctor or nurse if you have ulcers.

 A less common side effect you might have is a dry mouth.

Skin changes

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

A less common side effect you might have is flaky and peeling skin.

A rare side effect is 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. Contact your healthcare team straightaway if you have any of these symptoms.

Feeling or being sick

Feeling or being sick is usually well controlled with anti sickness medicines. It might help to avoid fatty or fried foods, eat small meals and snacks and take regular sips of water. Relaxation techniques might also 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 treat it once it has started.

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 healthcare team know straight away. Ask them if you can take paracetamol to help lower your temperature.

Changes to how your liver works

You might have liver changes that are usually mild and unlikely to cause symptoms. They usually go back to normal when treatment finishes. You have regular blood tests to check for any changes in the way your liver is working.

On very rare occasions there might be damage to the liver which can be very severe. This can cause yellowing of the skin and eyes, pain of the right side, a swollen tummy and feeling or being sick. Contact your healthcare team if you have any of these symptoms.

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 the 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
• a drop in thyroid hormone levels which can make you feel tired, unable to cope with the cold and you might get muscle cramps
• 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 (fewer than 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.
• an allergic reaction that can cause rash, shortness of breath, redness or swelling of the face and dizziness
• skin cancer (non melanoma 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 you need to know?

Other medicines, foods and drink

Cancer drugs can interact with medicines, herbal products, and some food and drinks. We are unable to list all the possible interactions that may happen. An example is grapefruit or grapefruit juice which can increase the side effects of certain drugs.

Tell your healthcare team about any medicines you are taking. This includes vitamins, herbal supplements and over the counter remedies. Also let them know about any other medical conditions or allergies you may have.

Pregnancy and contraception

This drug may harm a baby developing in the womb. It is important not to become pregnant or get someone pregnant while you are having treatment with this drug and for at least 2 months afterwards.

Talk to your doctor or nurse about effective contraception before starting treatment. Let them know straight away if you or your partner become pregnant while having 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 get someone pregnant 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 might be able to store sperm before starting treatment. And women might be able to store eggs or ovarian tissue. But these services are not available in every hospital, so you would need to ask your doctor about this.    

Treatment for other conditions

If you are having tests or treatment for anything else, always mention your cancer treatment. For example, if you are visiting your dentist.

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 one of the shingles vaccines called Zostavax.

You can have:

• other vaccines, but they might not give you as much protection as usual
• the flu vaccine (as an injection)
• the coronavirus (COVID-19) vaccine - talk to your doctor or pharmacist about the best time to have it in relation to your cancer treatment

Members of your household who are aged 5 years or over are also able to have the COVID-19 vaccine. This is to help lower your risk of getting COVID-19 while having cancer treatment and until your immune system recovers from treatment.

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. Sometimes people who have had the live shingles vaccine can get a shingles type rash. If this happens they should keep the area covered.

If your immune system is severely weakened, you should avoid contact with children who have had the flu vaccine as a nasal spray as this is a live vaccine. 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 and possible side effects go to the electronic Medicines Compendium (eMC) website. You can find the patient information leaflet on this website.

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