Nivolumab (Opdivo)

Nivolumab is a type of immunotherapy. It’s also known as Opdivo. You pronounce it ni-vol-you-mab.

It’s a treatment for a number of different types of cancer.

Depending on your cancer type you might have nivolumab on its own or in combination with other anti cancer drugs. 

You might have nivolumab as part of a clinical trial .

How does nivolumab work?

Nivolumab is a type of immunotherapy called a checkpoint inhibitor. It is also described as a as a type of monoclonal antibody or targeted treatment .

Checkpoint inhibitors work by blocking a protein that stops the immune system from working properly and attacking cancer cells. Nivolumab blocks a protein called PD-1 (programmed cell death protein 1).

How do you have nivolumab?

You have nivolumab through a drip into your bloodstream (intravenously) or as an injection under the skin (subcutaneously).

Into your bloodstream

You might have treatment through a long plastic tube that goes into a large vein in your chest. The tube stays in place throughout the course of treatment. This can be a:

• central line
• PICC line
• portacath

If you don't have a central line

You might have treatment through a thin short tube (a cannula) that goes into a vein in your arm. You have a new cannula each time you have treatment.

Injection under your skin (subcutaneous injection)

You usually have an injection under the skin (subcutaneous injection) into the stomach or thigh over about 3 to 5 minutes.

The area might be painful, sting or you may have a dull ache for a short time after this type of injection, but they don't usually hurt much. The skin in the area may go red, itchy or swollen for a while.

How often do you have nivolumab?

You have nivolumab as a course of several cycles of treatment. This means that you have the drug and then a rest to allow your body to recover.

If you are having nivolumab on it's own you have it every 2 or 4 weeks depending on your cancer type. If you are having it combination with other cancer drugs you have it every 3 weeks. Your healthcare team will tell you more about your treatment plan.

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, kidneys and thyroid gland are working.

Before treatment starts you may have a blood test to check for viruses such as hepatitis B, hepatitis C, and HIV . This is called a viral screen.

It’s important for your doctor to know if you have had any of these viruses. This is because this treatment can weaken your immune system and can cause the virus to become active again (reactivation). 

What are the side effects of nivolumab?

Side effects can vary from person to person. They also depend on what other treatment you are having. 

When to contact your team

Your doctor, pharmacist or nurse 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. 

We haven't listed all the side effects here. Talk to your healthcare team if you have any new symptoms that you think might be a side effect of your treatment.

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:

Tiredness and weakness (fatigue)

You might feel very tired and as though you lack energy.

Various things can help you to reduce tiredness and cope with it, for example exercise. Some research has shown that taking gentle exercise can give you more energy. It is important to balance exercise with resting.

Pain in different part of the body

It is common to feel some pain in your tummy (abdomen), muscles and joints of your body. You may also get pain in other areas of the body, but this happens less often.

Let your healthcare team know if you have pain, they can give you painkillers to take to help with this.

Diarrhoea

Contact your advice line if you have 4 loose watery poos (diarrhoea) or more in 24 hours. Or if you have diarrhoea for more than 3 days. Or if you can't drink to replace the lost fluid.

Eat less fibre, avoid raw fruits, fruit juice, cereals and vegetables, and drink plenty of liquid to replace the fluid lost.

Skin problems

Symptoms of skin problems that are common with nivolumab include a rash and itching.

Less commonly you might develop reddening of the skin, pale white patches of the skin (vitiligo) or dry skin.

Your skin might develop patches that are raised, red, flaky and crusty (psoriasis). There may also be silvery or grey scales that form. Or you might develop red spots that might be itchy. They may start on your legs or arms but sometimes on your face or other parts of the body. These conditions are rare. 

Very rarely you might have 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.

Your doctor and nurse will check your skin regularly throughout your treatment.

Difficulty breathing or a cough

It is important to tell your doctor or nurse if you have a cough or feel breathless.

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 not feel like eating. 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.

Constipation

Constipation is easier to sort out if you treat it early. Drink plenty and eat as much fresh fruit and vegetables as you can. Try to take gentle exercise, such as walking. Tell your healthcare team if you think you are constipated. They can give you a laxative if needed.

Increased risk of 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.

Less commonly you might get an infection in your lungs that could affects your breathing . Symptoms can include a cough, breathlessness, wheeze, chest pain and a sore throat.

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

High temperature (fever)

Tell your healthcare team straightaway if you get a high temperature. Ask them if you can take paracetamol to help lower your temperature.

Breathlessness and looking pale

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

Changes in blood sugar levels

You might have changes to your blood sugar levels. Its common with this treatment to get high blood sugar levels (hyperglycaemia). Symptoms can include feeling very thirsty, a dry mouth, passing urine very often, feeling tired, blurred vision, weight loss, feeling or being sick, and fruity smelling breath.

Less commonly your blood sugar levels can drop (hypoglycaemia). Symptoms include sweating, feeling hungry, shaky, trembling, fast heartbeat, dizziness, changes to your mood and feeling tired.

Rarely you may develop diabetes .

Bruising, bleeding gums or nose bleeds

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).

Changes in the levels of substances in your blood

Your blood contains different levels of minerals, electrolytes and proteins.

This treatment can change the levels of calcium, albumin, magnesium, sodium, potassium, creatinine, and bilirubin in your blood. It can also change enzymes in the liver and pancreas.

You have regular blood tests during treatment to check this.

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:

• a reaction to the drug – you might get a rash, shortness of breath, redness or swelling of the face, and dizziness. Tell your healthcare team straight away if this happens
• a reaction to the drug during or shortly after causing your immune system makes a large amount of cytokines . Symptoms include fever, chills, a headache, difficulty breathing and dizziness
• inflammation of the bowel (colitis) – this can cause diarrhoea with or without blood or pus, tummy pain or cramps, tiredness, and problems having a poo
• heart problems – your heartbeat might get faster or become irregular. Less commonly you might have inflammation or buildup of fluid around the heart. Symptoms of heart problems include chest pain or tightness, shortness of breath even when you are resting, fever and generally feeling unwell. Call your advice line if you have any of these symptoms 
• pressure, heaviness, tightness, squeezing across the chest or difficulty breathing – contact your advice line or call 999 immediately
• feeling dizzy  
• lung problems making it difficult to breath – you may have fluid around the lungs (pleural effusion). Or you might have inflammation of the lungs that can cause breathlessness or a cough
• thyroid problems - you might feel tired, gain or lose weight, sweat more than usual, or have a fast pounding heartbeat. You may also have pain around your neck. Your may have medicine to control your thyroid levels. You may need to have them for a long while or for life  
• weight loss
• numbness, tingling, weakness or burning pain in the arms or legs
• high blood pressure (hypertension) – symptoms include headaches, nosebleeds, blurred or double vision or shortness of breath. You have your blood pressure checked regularly
• mouth ulcers and sores
• dry mouth
• hair thinning or hair loss
• eye problems – your eyes might feel dry and you may notice you have blurred vision. Rarely your eyes may be painful and swollen
• inflammation of the kidneys - symptoms include high blood pressure, feeling or being sick, dark urine, blood in your urine, passing less or more urine, feeling tired, a high temperature, and pain in your lower tummy
• lack of fluid in your body (dehydration)
• a build up of fluid in different part of the body – this is called oedema
• pain, redness, and swelling around the injection site
• inflammation or swelling of your joints (arthritis)

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:

• long term problems caused by inflammation in some organs and tissues. The most common site is the lungs (sarcoidosis)
• your adrenal glands stop working properly this can make you feel tired, sick or dizzy. You may need medicine such as steroids .  If they stop working suddenly you can feel very ill and will need medical attention. Call your healthcare team straight away
• pituitary gland problems that can cause fatigue, feeling generally week, joint pain, vision problems, and headaches
• imbalance of substances in your blood (metabolic acidosis) – it can cause confusion, tiredness, shortness of breath, and headaches
• inflammation or damage to nerves causing numbness and weakness, tingling or burning pain
• the immune system attacking the nervous system (Guillain-Barre syndrome) - causing numbness, weakness, pain and paralysis of parts of the body
• inflammation of the liver – symptoms may include muscle, joint or tummy pain, feeling or being sick, feeling tired or weak, a high temperature, loss of appetite, yellowing of the whites of the eyes or skin, or dark coloured pee
• slow or blocked bile ducts - symptoms can include pale or clay coloured poo, dark wee, feeling itchy, feeling or being sick, tummy pain, yellowing of the whites of the eyes or skin
• inflammation of your pancreas – symptoms include severe tummy pain, feeling or being sick, a high temperature or you may have loose poo
• inflammation of the stomach lining – symptoms can include tummy pain, indigestion, feeling or being sick, feeling full or you may burp or fart
• acid in the blood produced from diabetes (diabetic ketoacidosis)
• inflammation of the blood vessels (vasculitis), pancreas, heart, stomach, and liver
• inflammation of tissues covering the brain and spinal cord (aseptic meningitis) - symptoms might include fever, headaches, neck pain or stiffness, feeling or being sick, or sensitivity to light
• a condition that causes general swelling of the lymph nodes , you may also have other symptoms that include a fever, a rash and you can feel very tired
• the parathyroid gland not producing enough parathyroid hormones. You may notice a tingling feeling in your fingers and toes, muscle cramps in particular in your legs, your skin looks and feels dry and you feel generally weak
• loss of the protective sheath around the nerve - symptoms include muscles weakness, uncontrolled movements and feeling very tired
• inflammation of the brain
• ulcers in the small bowel (the duodenum)
• a condition in which the immune system attacks the glands that make moisture for the body. This can affect tears and saliva (Sjogren’s syndrome)

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:

• changes to the levels of chemicals in your blood due to the breakdown of tumour cells (tumour lysis syndrome) - you have regular blood tests to check for this
• when your immune system makes too many white blood cells causing inflammation and damages tissues of the body. Symptoms can include a high temperature and rash. Your spleen , liver or lymph nodes maybe swollen
• your immune system treating an organ transplant like a foreign body. This means your body could reject the organ
• inflammation of the spinal cord - your arms and legs may be painful, numb, tingle or feel weak. It can affect your bladder and bowel. You may lose control of when you pee and poo or it may change how frequently you go
• patches of skin that may be itchy, painful, white, cracked or smooth. They can get damaged and bleed easily. This is called lichen sclerosus and can happen anywhere on the body. But it mainly affects the genitals

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 treatment may harm a baby developing in the womb. It is important not to become pregnant or get someone pregnant while you are having treatment. Women must not become pregnant while you are having treatment and for 5 months afterwards.

Talk to your doctor or nurse about effective contraception before starting treatment. Let them know straight away if you become pregnant while you're having treatment.

Breastfeeding

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

Loss of fertility

It is not known whether this treatment affects fertility in people. Talk to your doctor before starting treatment if you think you may want to have a baby in the future.

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, and yellow fever.

You can usually 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 a vaccine in relation to your cancer treatment.

Contact with others who have had immunisations 

You can be in contact with other people who have had live vaccines as injections. If someone has had a live vaccine by mouth or nasal spray there may be a small risk the vaccine virus can be passed onto you if your immune system is weakened.

Your healthcare team will let you know if you need to take any precautions if you are in close contact with someone who has had a live vaccine.

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.