This information is for anyone with Crohn’s Disease or Ulcerative Colitis (the two main forms of Inflammatory Bowel Disease - IBD) who is considering, or has started, treatment with adalimumab. Adalimumab is also known as Humira or the biosimilars Amgevita, Hyrimoz, Imraldi, and Hulio.
It looks at:
• how the drug works
• what you can expect from treatment
• possible side effects
• stopping or changing treatment.
The information also aims to help you talk to your IBD team about the possible benefits and risks of adalimumab. And ask all the questions you need to make an informed decision about your treatment.
Adalimumab is a biological medicine. It is known by the brand names Humira, Hulio, Imraldi, Hyrimoz, Amgevita.
Humira was the first version of adalimumab to be made and is the ‘originator’ medicine. Hulio, Imraldi, Hyrimoz and Amgevita are ‘biosimilars’ of Humira. They work in the same way and have same treatment effects but there will be some slight differences between them. For more information about biosimilars see our information on Biologic Medicines.
You should be prescribed the drug by brand name so that it is clear which brand of adalimumab is being used.
Adalimumab is my little bit of magic in a pen: I have been on this treatment over 3 years.
The aim of treatment with adalimumab is to reduce inflammation in the gut, improve symptoms, maintain remission and provide better quality of life.
Adalimumab may be a suitable treatment when other drugs such as azathioprine or methotrexate (immunosuppressants) have not worked or have caused severe or hard to manage side effects. It can also be used if you have lost response to another biologic drug such as infliximab, or if surgery is not considered appropriate for you.
If you have Crohn’s Disease, adalimumab is available to treat moderate to severe active Crohn’s Disease in adults, and moderate to severe active Crohn’s in children and young people from 6-17 years of age. It is used when treatment with other Crohn's and Colitis medicines have not worked or when side effects have been severe.
If you have Ulcerative Colitis, adalimumab is available to treat moderate to severe active cases of the condition in adults when treatment with other medicines has not worked or when side effects have been severe.
Although not everyone responds to adalimumab, several large studies have shown that adalimumab can be effective in bringing about and maintaining remission in people with Crohn’s and Colitis.
The aim of treatment is to:
- reduce inflammation in the gut and bring about remission
- maintain remission (prevent flare-ups)
- improve quality of life by reducing or eliminating symptoms.
In large studies, around 6 out of 10 people responded well to adalimumab initially. And of those, more than 1 in 3 remained in remission after one year. It can also help to reduce the need for hospitalisation and surgery. Adalimumab has been used successfully to treat fistulas in people with Crohn’s who also have active inflammation in their gut. A fistula is an abnormal channel, tunnel or passageway that connects one internal organ to another, or to the outside surface of the body. A fistula might connect two parts of the bowel to each other, or the bowel to the vagina, bladder or skin. Find out more in Living with a Fistula.
In large studies, over 5 out of 10 people with moderate to severe Ulcerative Colitis given adalimumab responded to treatment. And after one year, around 1 in 4 remained in remission. For some people with Crohn’s or Colitis, adalimumab may be an effective option when treatment with another similar drug, infliximab, has not worked.
Adalimumab is a biologic medicine made from a synthetic (man-made) antibody. It works by targeting a protein in the body called tumour necrosis factor-alpha (TNF-alpha). Your body naturally produces TNF-alpha as part of its immune response, to help fight infections
Over-production of this protein is thought to be partly responsible for the ongoing inflammation in the gut of people with Crohn’s or Colitis. Adalimumab binds to the TNF-alpha, which reduces the inflammation and helps to relieve symptoms. It is known as an anti-TNF drug.
The thought of injecting myself filled me with dread, but it was so easy and is now just a part of my life that I don’t even think about!
Everyone responds differently when taking a new medicine. You may begin to feel better within a few days, or it may take up to three months after you start treatment. However, adalimumab doesn’t work for everybody and it is important that you have follow-up appointments by your IBD team to review how well it is working for you.
Adalimumab is given as an injection under the skin (subcutaneous injection). It cannot be taken by mouth in tablet form, because it would be destroyed by your digestive system.
Your adalimumab treatment will be supervised by a specialist doctor (gastroenterologist) experienced in the diagnosis and treatment of Crohn’s and Colitis. To begin with, a doctor or nurse will give you the injections. But once you are used to having the treatment, they will teach you how to inject yourself. Or you may be taught at home by a nurse from the company that supplies you with your medicine. If you prefer, it may be possible for someone else, such as a family member or a friend, to be trained to give the injections.
Adalimumab for adult use comes ready to use in either a pre-filled syringe or a pre-filled injection ‘pen’. The syringes or pens come in a pack, which also contain an alcohol pad for cleaning the skin before injecting.
Adalimumab for children may either come in a vial (small bottle) designed to fit onto a syringe using an adapter, a pre-filled syringe or pre-filled pen.
Usually, adalimumab will be delivered directly to your home by a special home delivery company.
The drug must always be kept in the fridge, or it will not work. If you are travelling, adalimumab can be stored at room temperature (25°C) out of sunlight for a maximum of 14 days. But it must be used within the 14 days or thrown away, even if it has been put back in the fridge. A small cool bag can be useful to carry your medication - find out more about travelling with adalimumab in Travel and IBD.
One of the most common side effects of adalimumab injections is pain at the injection site, sometimes with redness, itching and swelling. These tips can help:
Allow your medication to warm to room temperature
If you inject yourself with cold adalimumab straight from the fridge, it may be uncomfortable. Try taking it out of the fridge around 15-30 minutes before you take it so it can warm to room temperature. You must not leave adalimumab out of the fridge for more than 30 minutes. If you think you have left it out of the fridge longer than this, do not use it, put it back in the fridge and contact your IBD team as soon as possible.
Apply an ice pack before you inject
If you are worried about pain at the injection site, you could try applying an ice pack to the area for 2-3 minutes before you inject.
Clean with an alcohol wipe
Remember to clean the skin with an alcohol wipe before you inject yourself.
Choose your injection site
The upper thigh or stomach (away from the belly button) are good places for the injection – but avoid any areas where the skin is red, scarred, bruised or hard.
Use a good injection technique
Use a quick, dart-like motion to insert the needle into the pinched skin. Push the plunger slowly and evenly to inject all of the medicine, keeping pressure on the plunger head and keeping the skin pinched. If you use a syringe, the injection will take about 2-5 seconds; if you use a pen, this will take about 10 seconds.
Apply an ice pack after you inject
If your skin at the injection site hurts after you have the injection, it may help to apply an ice pack or cold damp towel to the area for about 10-15 minutes. If you do use an ice pack, place a light towel between it and your skin.
If you continue to have problems with pain at the injection site, you can ask your IBD team if you can try a different formulation of adalimumab.
The dose you are prescribed and how often you need to take it will vary according to your condition. Children will be given smaller doses than adults. The starting dose if you have Crohn’s Disease may be different than that if you have Ulcerative Colitis.
Treatment starts with induction doses at week 0 and then week 2, which are higher to allow rapid response. These can either be 160mg and then 80mg two weeks later or 80mg and then 40mg two weeks later. The standard maintenance dose is 40mg every two weeks.
If response to 40mg of adalimumab every other week reduces over time this may be increased to 40mg every week or 80mg every other week.
Treatment starts with induction doses at week 0 and then week 2, which are higher to allow rapid response. This is 160mg and then 80mg two weeks later. The standard maintenance dose is then 40mg every two weeks.
Your ongoing dose may be increased to 40mg every week, or 80mg every other week depending on how you respond to the treatment. The levels of the drug in your blood may also be measured by your IBD team and these may also be used to help decide your dosing regimen.
Some types of adalimumab pre-filled pen or syringe contain 40mg of the drug. This means that you will need more than one injection when you have the initial doses.
You are likely to have a planned course of adalimumab lasting up to a year if symptoms improve and there are no serious unwanted effects. Treatment will be reassessed at least every 12 months to check if ongoing treatment is still right for you
There are a few reasons why you and your IBD team might think the time is right to stop or change your treatment.
If adalimumab is not effective for you
If there has not been any response to treatment within 12 weeks if you have Crohn’s or 8 weeks if you have Colitis. You may be able to try a different biologic drug such as infliximab, golimumab, vedolizumab or ustekinumab. See individual drug information sheets.
If at the end of the year your condition is in stable remission it may be decided that you can stop taking adalimumab. If you relapse after treatment has stopped, you should be able to start treatment again.
Treatment may be stopped if you experience side effects that are serious or difficult to manage.
Adalimumab becomes less effective
Some people develop antibodies to adalimumab over time. This happens when the body produces an immune response to the drug. These antidrug antibodies may reduce the effectiveness of the treatment. If you have lost response to adalimumab and still have ongoing inflammation you may be able to switch to another biologic medicine such as infliximab, golimumab, vedolizumab or ustekinumab.
Adalimumab is sometimes given with steroids to help bring on remission, after which steroid treatment can be reduced. It can also be used in combination with immunosuppressant drugs such as azathioprine or methotrexate.
There is some evidence that this combination therapy reduces the risk of developing antibodies to the drug. However, studies have suggested that combination therapies may also increase the risk of side effects, including infections and some types of cancer.
Screening before treatment is essential to check that adalimumab is right for you. Make sure your IBD team know if you have a history of:
- Tuberculosis: If you have any history of tuberculosis (TB) or any recent exposure to people with TB. You should not be given adalimumab if you have active TB, and if you have underlying, inactive TB, this will need to be treated before starting adalimumab. Most doctors now use a blood test to check for underlying or inactive TB, but you may be given a chest x-ray as well.
- HIV, hepatitis B or C: If you have or have ever had any of these infections, are a carrier of hepatitis B or C (a viral liver infection), or have been in close contact with someone who has hepatitis B or C. You will usually have a blood test to check for these diseases before starting adalimumab.
- Infections: If you have a history of infections or currently have an infection (such as tonsillitis or a urinary tract infection) or have symptoms such as feeling feverish or generally unwell. If you have an infection your adalimumab treatment may need to be postponed until the infection has cleared. This is because taking adalimumab could make the infection worse.
- Heart problems: If you have heart problems, adalimumab may make your symptoms worse, and your heart will need to be monitored closely before, during, and after treatment.
- Cancer: If you have a history of cancer. Adalimumab affects the way in which your immune system works, and you may have an increased risk of developing some types of cancer. However, you may also be at risk even if you do not have a history of cancer.
And tell your IBD team if:
- you smoke or have COPD (Chronic Obstructive Pulmonary Disease).
- you have ever had a disease that affects the nervous system, including any symptoms of numbness, tingling or vision problems such as multiple sclerosis.
- you have had kidney or liver disease.
- you are pregnant, planning to get pregnant or are breastfeeding.
- you are taking any other medications or have had any vaccinations recently
- you are having any surgery.
- you travel to regions of the world where TB or fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
- if you have or have not been exposed to chickenpox in the past. If you have not had chickenpox, you may be able to be vaccinated against it before you start adalimumab.
Once your treatment has started you will need regular checks, including blood tests. Monitoring your treatment helps your IBD team fit your treatment to your needs. It can also make sure that any problems with treatment are avoided or caught at an early stage.
At some hospitals, a blood test may also be used to check the levels of adalimumab in your blood. Blood tests can also help your IBD team see whether you have developed antibodies to it.
Because adalimumab affects the way your immune system works, you may be more prone to infections. Even a mild infection such as a cold or sore throat could develop into a more serious illness. Tell your doctor or hospital if you begin to feel unwell and think you might have an infection.
To reduce this risk:
- Have the annual flu vaccination. You will also be advised to have a pneumonia vaccination while on adalimumab treatment. Pneumococcal infections can lead to pneumonia (inflammation of tissue in the lungs) septicaemia (a kind of blood poisoning) and meningitis (an infection of the protective membranes that surround the brain and spinal cord).
- Try to avoid close contact with people who have infections. This includes viruses and bacteria that cause chickenpox and shingles, measles, and pneumococcal disease. Contact your doctor or the hospital if you begin to feel unwell and think you may have caught an infection.
- Take care with food hygiene. You may be more at risk of infections caused by bacteria found in food such as listeria. Avoid eating raw eggs or undercooked pate, meat and poultry, as well as unpasteurised dairy products which may include some soft or blue cheeses.
- Take care in the sun. Adalimumab can increase the risk of skin reactions, and in rare cases skin cancer. As do azathioprine and mercaptopurine, which may be prescribed alongside adalimumab. You should take extra precautions when in the sunlight, for example wearing a hat and high factor sun cream.
I have to cope with certain side effects such as pain at the site of injecting and flu-like symptoms such as headache and general achiness but this usually subsides within a couple days. Don’t be scared – it is easier than it seems at first.
Like all drugs, adalimumab can have side effects, although not everybody will get them. Some side effects can happen almost immediately, others may develop later. It can take up to six months after the last dose for adalimumab to completely leave the body, so some effects might appear even after stopping treatment.
Some adalimumab side effects are likely to be quite mild and may go away on their own. Others can be more serious and will require treatment, or may mean that adalimumab is not suitable for you.
- Reactions to the injection such as pain or swelling, redness, bruising and itching. Using the adalimumab at room temperature or cooling your skin with an ice pack may help. Your doctor or IBD nurse should also be able to help you find ways to reduce this sort of reaction or you may be able to try a different brand of adalimumab.
- Allergic reactions to adalimumab. For example, rashes, hives (a raised itchy rash that appears on the skin), a swollen face, hands and feet, or trouble breathing and shortness of breath.
Other side effects:
- Risk of infection. A greater chance of getting infections such as colds and flu and some more serious ones such as pneumonia and sepsis. You may also be at greater risk of developing tuberculosis (TB) or of having underlying TB reactivated while on adalimumab. Symptoms of an infection often include feeling very tired, fever, cough, and warm painful skin. You may need to stop the adalimumab if you have an infection, so check with your medical team first if you think you have or are developing an infection.
- Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, sore throat, or looking very pale.
- Liver problems. Contact your doctor if your skin or eyes look yellow, you feel very tired with a lack of appetite, or you have a persistent pain on the right hand side of your tummy (abdomen). Adalimumab can also activate viral hepatitis if you carry it in your blood. Your doctor will check if you are a carrier before you start treatment, and continue with blood tests while you are on the drug to make sure it does not activate.
- Skin reactions. These include psoriasis (scaly patches) and eczema, other skin rashes and ulcers. Some of these can be treated without stopping.
- Some types of skin cancer. You must tell your doctor if you have a bump or open sore which is not healing.
- Cancers including lymphoma (cancer of the lymph glands). This has been reported as an uncommon side effect of adalimumab (in around 1 in 1,000 people) and more rarely still, leukaemia (in around 1 in 10,000). You may be more at risk if you are also taking immunosuppressive drugs such as azathioprine or methotrexate. However, it is difficult to know what the exact risk is, as cancers in these circumstances happen rarely and very few people are affected.
- Heart problems. This includes heart failure or worsening of heart failure you already have. Call your doctor immediately if you get new or worsening symptoms of heart failure while taking adalimumab. This includes shortness of breath, swelling of your ankles or feet, or sudden weight gain.
- Damage to nerves. This is a very rare complication that includes demyelination (damage to nerves) and some rare inflammatory conditions, including lupus (an autoimmune condition).
Many of these serious side effects are reversible if the drug is stopped.
Tell your doctor immediately if you develop any of the following symptoms:
- A severe rash, hives (swollen red patches of skin) or other signs of allergic reaction
- Swollen face, hands and feet
- Trouble breathing or swallowing
- Shortness of breath.
It is unsafe to have “live” vaccines while on adalimumab and for five months after you stop treatment. Live vaccines contain viruses that have been weakened, but not destroyed. People who are taking medicines which affect the immune system may not be able to produce antibodies quickly enough and risk becoming infected by the disease.
Live vaccines include:
- yellow fever
- rubella (German measles)
- BCG (tuberculosis)
- MMR (measles, mumps and rubella).
However, you may be able to have the inactivated polio vaccine.
Flu jabs are currently safe as the adult vaccines are not live. The Department of Health recommends that everyone on drugs such as adalimumab should have an annual flu vaccination. But if anyone in your family or household is due to have a live vaccine, check with your IBD team whether you need to take any special precautions.
If you have a baby whilst on treatment, your baby should not be given live vaccinations for five months after your last adalimumab injection during pregnancy.
Adalimumab may interact with other drugs.
Do not take medicines that contain the active substances anakinra or abatacept. These drugs are commonly used for treating Rheumatoid Arthritis.
Tell your doctor if you are taking or intend to take any over the counter medicines that you buy yourself. Or any herbal, complementary, or alternative medicines or therapies.
Do I need to tell other health professionals?
Tell any other doctor, dentist or other health professional treating you that you that you are taking adalimumab. Always carry the alert card while you are on the medication and for five months after your last dose. This is provided by the company that makes the medicine.
Research is still ongoing into the possibility of long-term effects of adalimumab on the baby, and manufacturers state that adalimumab should only be used during pregnancy if clearly needed. They also advise using effective contraception to prevent pregnancy when you are taking adalimumab, and to continue using it for at least five months after your last treatment.
Your doctor should discuss the risks and benefits of taking adalimumab while pregnant and you may find it helpful to talk through your options with your IBD team. According to a review of pregnancy studies, there was no higher risk of birth defects when the mother received adalimumab during pregnancy, compared with mothers who did not receive adalimumab.
There is some evidence to show adalimumab is low risk during conception and for at least the first six months of pregnancy (first two trimesters). Stopping the medication from three to six months of pregnancy (second trimester) reduces the unborn baby’s exposure to the medication, but your doctor may consider it advisable to continue the drug in the last three months (third trimester), to keep your Crohn’s or Colitis in remission. This will reduce any risk associated with a flare-up for both you and your baby.
If you take adalimumab while you are pregnant, your baby may have a higher risk of getting an infection. Before your baby receives any vaccine, it is important to tell your baby’s doctors that you received adalimumab while pregnant. Your baby should not be given live vaccinations such as BCG for six months after your last adalimumab injection during pregnancy. There is less evidence for men wanting to father a child while on adalimumab, but it is thought that it is safe for a man to conceive a child while taking the drug.
Adalimumab is present in breast milk in very small amounts. Because it is destroyed by the digestive system when taken orally, adalimumab is likely to become ineffective and the manufacturer states that adalimumab can be used during breastfeeding.
Research is continuing into the possible effects small amounts of the drug might have on the baby, especially in the longer term. One study found breastfed infants of mothers on biologic drugs (such as adalimumab), immunosuppressants (such as azathioprine), or a combination of the two therapies had similar risks of infection and rates of milestone achievement compared with non breastfed babies. The study found that if you are taking a biologic medicine you should still be able to breastfeed your baby. If you are worried, talk to your IBD team.
Alcohol is not known to have any interaction with adalimumab. But for general health reasons it is best to keep within the UK Chief Medical Officers’ guideline limits of no more than 14 units of alcohol a week on a regular basis.
If you are worried about your adalimumab treatment or have any questions, talk to your IBD team. They should be able to help you with any queries such as why it has been prescribed, what the correct dose and frequency are, what monitoring is in place, and what alternatives may be available for you. You can also talk to the Crohn’s & Colitis UK Helpline.
This information is about adalimumab in general and is not intended to replace specific advice from your doctor or any other health professional. For further information, talk to your doctor or specialist IBD team. You can also look at the Patient Information Leaflet (PIL) supplied with your medication or go to medicines.org.uk/emc/.
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Last reviewed: January 2019