Nintedanib (Vargatef)

Nintedanib is a targeted cancer drug. it’s also known as Vargatef. 

It is a treatment for a type of non-small cell lung cancer (NSCLC) called adenocarcinoma. 

Nintedanib is for people who have already had one type of chemotherapy and whose lung cancer has:

• spread to surrounding tissues (locally advanced )
• spread to distant parts of the body (metastatic cancer )
• returned after treatment

You have it with a type of chemotherapy called docetaxel. 

You may also have nintedanib as part of a clinical trial for other types of cancer. 

How does nintedanib work?

Nintedanib is a cancer growth blocker. It blocks particular proteins called protein kinases on the cancer cells. The protein kinases encourage the cancer to grow. Nintedanib blocks a number of these proteins and is called a multi kinase inhibitor. It also stops the cancer cells growing their own blood vessels, which the cells need to be able to grow.

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

How do you have nintedanib?

Nintedanib is a capsule that you swallow whole with a glass of water. Do not crush or chew the capsules. You should take nintedanib with food.

Taking your capsules

You should take the right dose, not 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 nintedanib?

You usually take nintedanib twice a day, morning and evening, 12 hours apart. 

You take nintedanib with docetaxel as part of a 21 day cycle of treatment . Your doctor will tell you how many cycles you will have.  

You have it in the following way:

When you have finished your treatment cycles taking docetaxel and nintedanib together, you carry on taking nintedanib on its own every day.

You usually keep taking it for as long as it is working or until the side effects get 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 nintedanib?

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. 

Diarrhoea

Contact your advice line if you have diarrhoea. For example, 2 or more extra loose bowel movements than usual each day. If you have a stoma, you might have more output than normal. Your doctor may give you anti diarrhoea medicine to take home with you after treatment.

Try to eat small meals and snacks regularly. It’s best to try to have a healthy balanced diet if you can. You don’t necessarily need to stop eating foods that contain fibre. But if your diet is normally very high in fibre, it might help to cut back on high fibre foods such as beans, nuts, seeds, dried fruit, bran and raw vegetables. 

Drink plenty to try and replace the fluid lost. Aim for 8 to 10 glasses per day.

Liver changes

You might have liver changes that are usually mild that are picked up on blood tests. Less commonly nintedanib can cause your liver to not work as well as it should and you may have a build up of the substance bilirubin. Nintedanib can also cause other serious liver problems but this is rare.

Tell your nurse or doctor if you have any of the following symptoms: itchy skin, yellowing of the skin and whites of the eyes, dark wee or tummy pain. 

You have regular blood tests to check for any changes in the way your liver is working.

Numbness or tingling in fingers or toes

Numbness or tingling in fingers or toes is often temporary and can improve after you finish treatment. Tell your healthcare team if you're finding it difficult to walk or complete fiddly tasks such as doing up buttons. 

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.

Loss of appetite

You might lose your appetite for various reasons while having cancer treatment. Sickness, taste changes or tiredness can put you off food and drinks.

Change in the levels of minerals in the blood 

You may have changes to the levels of minerals and salts in your blood. These minerals and salts include potassium, sodium, magnesium, calcium, phosphate, and chloride. If you have a low potassium level, symptoms can include a fast heartbeat, tiredness, and feeling sick. 

Your healthcare team will do regular blood tests to check for any changes during your treatment. 

Skin rash

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.

Sore mouth

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.

Tummy (abdominal) pain

Tell your treatment team if you have this. They can check the cause and give you medicine to help. 

Bleeding

There is a risk of bleeding if you take nintedanib, the most common is a nosebleed. Less commonly you might have bleeding in other parts of your body, for example, your lungs, tummy (abdomen), or brain.

You may also notice you bruise more easily. Let your doctor or nurse know if this happens.

Contact your healthcare team straight away if you cough up blood, notice blood in your vomit, or blood in your poo. Or you have bleeding from your back passage. 

 Hair loss

You may have some hair loss or hair thinning. This can be upsetting. Your hair might grow back once treatment has finished.

Occasional side effects

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

• blood clots that can be life threatening; signs are pain, redness, and swelling where the clot is. Feeling breathless can be a sign of a blood clot in the lung. Contact your advice line or doctor straight away if you have any of these symptoms
• high blood pressure - symptoms can include headaches, blurred vision, nosebleeds and difficulty breathing
• dehydration - this means you lose more fluid than you take in. You might find you aren't passing much urine and the colour is a very dark yellow. Other symptoms include a dry tongue and mouth, dry skin, feeling tired, and feeling dizzy
• collection of pus (abscess) these can be painful and can develop anywhere in the body
• protein in your urine - you may notice you have to wee more often, or have swelling in your feet and around your face. Let your nurse or doctor know if this happens
• weight loss
• headaches

Rare side effects

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

• hole in the stomach or bowel
• heart attack
• inflammation of your pancreas (pancreatitis) - symptoms include severe tummy pain, feeling or being sick, a high temperature or you may have loose poo
• kidney failure - symptoms include passing wee more often, and in smaller amounts than usual, blood in your wee, swelling in your legs and ankles, feeling sick and very tired

Other side effects

There isn't enough information to work out how often these side effects might happen. You might have one or more of them. They include:

• a tear or a bulge in a weakened blood vessel that can be serious
• inflammation of the bowel (colitis) symptoms can include diarrhoea, passing blood when you have a poo, urgency to have a poo, and tummy pain
• slow wound healing. If you need to have an operation you may need to stop taking nintedanib for a while beforehand. Your doctor will let you know when you can start taking it again

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.

Do not take nintedanib if you are allergic to peanuts and soy. The capsule contains soya products. People who have a peanut allergy can also have an allergic reaction to soya preparations. This allergic reaction could be life threatening. 

Pregnancy and contraception

Nintedanib may harm a baby developing in the womb. It is important not to become pregnant or father a child while you are having treatment with this drug and for at least 3 months afterwards.

Talk to your doctor, nurse, or pharmacist about effective contraception before starting treatment. This treatment may have an effect on how well hormonal contraceptives work. If you’re taking hormonal contraceptives like the pill, injections, or patches you should use additional barrier contraceptives such as condoms.

Let your doctor or nurse know straight away if you or your partner falls pregnant while having treatment.

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.    

Breastfeeding

It is not known whether this drug comes through into breast milk. Doctors usually advise that you don’t breastfeed during this treatment

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.