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Adalimumab - including Humira, Amgevita, Imraldi, Hyrimoz and Hulio

1. About adalimumab

How to say adalimumab: AH-dah-lee-mu-mab.

Adalimumab is a biological medicine. It's used to reduce inflammation by acting on your immune system.

Humira is the brand name of the original adalimumab medicine. There are now 4 new versions of adalimumab.

Brand names include Amgevita, Imraldi, Hyrimoz and Hulio. More brands are likely to be available at the end of 2019.

These new medicines are biosimilars. A biosimilar is a similar version of an original biological medicine.

Adalimumab biosimilars are equally safe and effective in reducing inflammation as Humira (the original adalimumab medicine).

All versions of adalimumab are used to treat inflammation of the:

  • joints (rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis)
  • skin (plaque psoriasis and hidradenitis suppurativa)
  • joints and skin (psoriatic arthritis)
  • spine, causing back pain (axial spondyloarthritis, including ankylosing spondylitis)
  • gut and ulcers in the lining of the gut (Crohn's disease and ulcerative colitis)
  • the layer beneath the white of the eyeball (non-infectious uveitis)

Adalimumab is available on prescription. It comes as a pre-filled syringe or injection pen that you inject under the skin.

Your adalimumab will be delivered to your home by a homecare provider.

You'll be shown how to use the injection by a homecare support nurse so you can give yourself or your child the injection at home.

You'll need to store the injections in your fridge.

If you're switching from Humira to an adalimumab biosimilar, the way the injection works might be different.

You can ask your specialist, homecare support nurse or pharmacist for training on the new injection if you need it.

If there are any changes to your homecare provider, you'll be told before any changes are made.

2. Key facts

  • Adalimumab is known by the brand names Humira, Amgevita, Imraldi, Hyrimoz and Hulio.
  • Adalimumab biosimilars are just as safe and effective as Humira.
  • It takes a few weeks for Humira and adalimumab biosimilars to work. It may take longer depending on your condition.
  • They work by blocking part of your immune system to reduce inflammation.
  • If you're switching from Humira to a different brand of adalimumab, the way the injection pen or syringe works might be different.

3. Who can and can't take adalimumab

Adalimumab can be used by adults, and some brands can be used by children.

Adalimumab is not suitable for some people.

To make sure this medicine is safe for you, tell your specialist if you:

  • have had an allergic reaction to adalimumab or any other medicines in the past
  • have an infection or a fever, or feel unwell
  • have or have had tuberculosis, or been in contact with someone with it
  • have heart failure
  • have hepatitis B
  • have a nervous system disease, including multiple sclerosis, optic neuritis and Guillain-Barré syndrome
  • have or have had cancer
  • are about to have surgery or a dental procedure
  • are pregnant or trying to get pregnant - it's best to use contraceptives and continue to use them for at least 5 months after your last adalimumab treatment
  • are allergic to latex - the Hyrimoz syringe and injection pen and Amgevita injection pen are not latex-free

4. How and when to use it

Adalimumab comes as a pre-filled syringe or injection pen.

You'll be shown how to use the injection by a specialist nurse, pharmacist or homecare support nurse so you can give yourself or your child the injection at home.

Dosages

Adalimumab is a prescription medicine. It's important to take it as advised by your specialist.

For adults, dosages and how often you take it depends on your condition:

  • plaque psoriasis - the usual starting dose is 80mg, then 40mg after a week and then 40mg every 2 weeks.
  • rheumatoid arthritis - the usual dose is 40mg every 2 weeks. It can be taken weekly if you're not taking any other medicine for rheumatoid arthritis.
  • psoriatic arthritis, axial spondyloarthritis, including ankylosing spondylitis - the usual dose is 40mg every 2 weeks.
  • Crohn's disease - the usual starting dose is 80mg and then 40mg every 2 weeks. It can be taken weekly if needed. If you need a higher dose, you can start with 160mg, 80mg after 2 weeks and then 40mg every 2 weeks.
  • ulcerative colitis - the usual starting dose is 160mg, then 80mg after 2 weeks and then 40mg every 2 weeks.
  • hidradenitis suppurativa - the usual starting dose is 160mg, then 80mg after 2 weeks and then 40mg after another 2 weeks, then 40mg every week.
  • non-infectious uveitis - the usual starting dose is 80mg, then 40mg after a week and then 40mg every 2 weeks.

For children, dosages are usually based on their weight. How often they take it depends on their condition:

  • plaque psoriasis - after the first dose, the next dose is given after 1 week, and then every other week.
  • juvenile idiopathic arthritis - after the first dose, doses are usually given every other week. It can be given weekly if needed.
  • enthesitis-related arthritis - doses are given every other week.
  • Crohn's disease - after the first dose, doses are normally given every other week. It can be given weekly if needed.
  • non-infectious uveitis - after the first dose, doses are given after 1 week, and then every other week.

Important

Patient alert card

When you start taking adalimumab you'll be given a patient alert card. Carry this with you all the time.

It tells healthcare professionals that you're taking adalimumab. This can be useful for them to know in case of a medical emergency.

If you do not have a patient alert card, you can ask your specialist for one.

What if I forget my dose?

If you forget to give yourself an injection, you should inject the dose as soon as you remember. Take your next dose on the original scheduled day.

If it's close to the day of your next dose, speak to your specialist. They'll let you know whether to skip the missed dose.

What if I take too much?

Call your doctor or specialist if you have accidentally taken too much.

Have the medicine packet or leaflet inside it, plus any remaining medicine, with you.

5. Side effects

Common side effects

Common side effects happen in more than 1 in 10 people:

  • pain, swelling, redness or itchy skin where your injection was given
  • a mild nose, throat or sinus infection
  • a headache
  • stomach pains, feeling or being sick
  • a rash
  • muscle or bone pains

You might experience side effects up to 4 months after you stop taking adalimumab.

Speak to your specialist if you experience any side effects.

Serious side effects

Serious side effects are uncommon and affect less than 1 in 100 people.

You should tell your specialist or doctor if you experience:

  • infections, including a fever, chills, unusual sweating, feeling unwell or more tired than normal, diarrhoea, coughing up blood or mucus, shortness of breath, problems urinating, skin sores, wounds or muscle aches - these could be signs of a severe infection
  • shortness of breath, swelling of your ankles or feet - these could be signs of heart failure
  • night sweats, swollen glands (lymph nodes) in the neck, armpits, groin or other areas, weight loss, changes to your skin, such as lumps or sores (skin lesions), changes to moles or freckles you already have, severe itchiness that cannot be explained - these could be signs of cancer
  • numbness or tingling, vision changes, muscle weakness, unexplained dizziness - these could be signs of nervous system problems
  • persistent fever, bruising, very easy bleeding - these could be signs of a blood disorder
  • worsening symptoms or unexplained symptoms - these could be signs of autoimmune conditions

Serious allergic reaction

In rare cases, adalimumab may cause a serious allergic reaction (anaphylaxis).

Urgent advice: Contact a doctor straight away if:

  • you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
  • you're wheezing
  • you get tightness in the chest or throat
  • you have trouble breathing or talking
  • your mouth, face, lips, tongue or throat start swelling

These are warning signs of a serious allergic reaction.

A serious allergic reaction is an emergency.

These are not all the side effects of adalimumab.

For a full list, see the leaflet inside your medicine packet.

Information:

You can report any suspected side effect to the UK safety scheme.

6. How to cope with side effects

What to do about:

  • pain, swelling, redness or itchy skin where your injection was given - take the syringe or pre-filled pen out of the fridge and leave at room temperature for 15 to 30 minutes before injecting. Do not warm it in any other way. Choose a different area of skin each time you give yourself an injection. These symptoms are usually mild and should only last a few hours. You can ask a pharmacist to recommend a mild painkiller if the pain is bothering you.

  • mild nose, throat or sinus infection - rest and drink plenty of water. Speak to your pharmacist. They may recommend medicines to relieve your symptoms, such as a nasal spray. Speak to your doctor for advice if your symptoms get worse.

  • headache - rest and drink plenty of water. Do not drink too much alcohol. Ask your pharmacist to recommend a painkiller. Speak to your doctor if your headaches last longer than a week or get worse.

  • stomach pains, feeling or being sick - try to rest and relax. It can help to eat and drink slowly and have smaller, more frequent meals. Putting a heat pad or covered hot water bottle on your stomach may also help. Stick to simple meals and do not eat rich or spicy food. If you're being sick, try having small, frequent sips of water. If you're in a lot of pain, speak to your pharmacist or doctor.

  • muscle or bone pain - speak to your pharmacist about painkillers for mild to moderate pain. If you're in a lot of pain, speak to your specialist or doctor as soon as possible in case these are signs of a serious side effect.

7. Pregnancy and breastfeeding

It's not known if adalimumab is safe to use during pregnancy.

If you become pregnant while taking adalimumab, speak to your specialist about the benefits and possible risks.

For more information about how adalimumab can affect you and your baby during pregnancy, read the leaflet about the best use of medicines in pregnancy (BUMPS).

Adalimumab and breastfeeding

Adalimumab is thought to be safe to use while breastfeeding.

It passes into breast milk, but only in small amounts that are not harmful to the baby.

After your baby is born

If you're taking adalimumab while pregnant, your baby may be at a higher risk of getting an infection once they're born.

Speak to your doctor or midwife, as they may delay giving your baby live vaccines until they're at least 6 months old to avoid any risks of infection.

Non-urgent advice: Tell your doctor if you're:

  • trying to get pregnant
  • pregnant
  • breastfeeding

8. Cautions with other medicines

You should not take adalimumab with medicines that can increase the risk of serious infections:

  • live vaccination - some vaccines use live viruses; for example, measles mumps and rubella (MMR), shingles and some flu vaccinations
  • abatacept - a medicine to treat autoimmune diseases
  • anakinra - a medicine to treat rheumatoid arthritis

9. Common questions

How does adalimumab work?

Your immune system naturally produces a protein called tumour necrosis factor (TNF).

If your body produces too much TNF, it can cause inflammation.

Adalimumab stops TNF attaching and attacking healthy cells. This reduces inflammation and other symptoms of the diseases.

How long does it take to work?

It takes a few weeks to work. It may take longer depending on your condition.

If you switch to a biosimilar, it'll continue to work straight away.

What if it does not work?

All versions of adalimumab are equally effective and safe.

You'll have a review where your specialist checks your condition to see if the medicine is working for you.

If it's not working for you, your specialist may increase your dose or give you injections more often.

Sometimes your condition might change and your body may stop responding to the medicine, so you may need to try a different medicine instead.

How long do I have to wait until my treatment is reviewed?

Your specialist will review your condition after a few months to see if the treatment is working.

How long you wait will depend on your condition. Each condition will respond differently to adalimumab.

Different treatment centres also have different arrangements for reviewing, so your appointment may be earlier or later.

You'll usually be reviewed within 8 weeks for ulcerative colitis.

You'll usually be reviewed within 12 weeks for:

  • rheumatoid arthritis
  • psoriatic arthritis
  • axial spondyloarthritis, including ankylosing spondylitis
  • Crohn's disease
  • hidradenitis suppurativa
  • juvenile idiopathic arthritis
  • enthesitis-related arthritis

You'll usually be reviewed within 16 weeks for plaque psoriasis and juvenile plaque psoriasis.

What's the difference between a biological and a biosimilar medicine?

A biosimilar medicine is a similar version of a biological medicine.

They're as safe and effective as the biological medicine, but tend to be less expensive.

They're both made from living cells, so this means there'll be some small natural differences.

There might also be a difference in the way the injection syringe or pen works.

What's the difference between the Humira syringe and other adalimumab biosimilar syringes?

There's not much difference between the Humira syringe and other biosimilar syringes.

The Humira syringe comes with a needle shield.

The Amegvita, Imraldi, Hyrimoz and Hulio syringe have a retracting needle, where the needle goes back into the main part of the syringe once the injection has finished.

A needle shield or retractable needle helps reduce the risk of accidental needle injuries.

What's the difference between the Humira injection pen and other adalimumab biosimilar pens?

There's not much difference between the Humira injection pen and other biosimilar pens.

All the injection pens start with a loud click and have a small window on the injection, which changes colour when the injection has finished.

The Hulio pen also has a second click to let you know the injection has finished.

Why am I being switched from Humira to a biosimilar?

The new adalimumab biosimilars can cost the NHS less money than the original version, Humira.

Adalimumab biosimilars are as effective and safe as the original version, Humira.

If you switch, your body should respond the same way as if you'd stayed on Humira.

When will I switch to a biosimilar?

You'll receive a letter from your specialist with information about switching to a biosimilar and a possible timeline of when it could happen.

You can have a consultation with your specialist. They'll talk to you about your condition and your needs.

Your specialist will also explain any differences between Humira and a different brand of adalimumab, such as how it's delivered and injected.

Will I get more side effects if I switch?

Adalimumab biosimilars are just as safe as Humira. The risk of side effects are the same as Humira.

They have been thoroughly tested to show they work just as well and are just as safe.

Can I switch back?

If you have switched and the adalimumab biosimilar's not working for you, you can discuss with your specialist the possibility of switching to a different adalimumab biosimilar or switching back to Humira.

Are adalimumab biosimilars safe to use for a long time?

Adalimumab is safe to use for a long time and some patients continue to use it for many years.

Adalimumab biosimilars have been through exactly the same thorough testing process as Humira to show that they're just as safe.

You'll be monitored closely to check for any new or developing side effects.

Your specialist will review your treatment. You'll only continue to use adalimumab biosimilars if they're still working and still needed.

Will I lose my hair?

Hair loss is not a common side effect with adalimumab.

If it occurs, it's usually after a few months or years of treatment.

Speak to your specialist if you experience hair loss.

Are there any foods or drinks to avoid?

You can eat and drink normally while on adalimumab.

Your specialist may suggest some changes in your diet to help your condition.

Can you drink alcohol with it?

You can drink alcohol while taking adalimumab.

It's best to stick to the national guidelines of no more than 14 units a week for men and women.

A standard glass of wine (175ml) is 2 units. A pint of lager or beer is usually 2 to 3 units of alcohol.

Can it affect fertility?

There's no firm evidence to suggest that taking adalimumab will reduce fertility in either men or women.

It's best to use contraceptives and continue to use them for at least 5 months after your last adalimumab treatment.

Speak to your specialist if you're trying to get pregnant. They may want to review your treatment.

Can it affect contraception?

Adalimumab does not affect any type of contraception, including the combined pill and the morning after pill.

Will it affect driving or riding a bike?

Adalimumab may have a small effect on your ability to drive, cycle or use machines.

You might feel dizzy or have blurry vision after taking adalimumab.

If you experience any of these symptoms, do not drive, cycle or use machinery or tools.

Can lifestyle changes help reduce the risk of infection?

Adalimumab can make you more likely to suffer from infections.

To help prevent infections, you can:

  • wash your hands, particularly after using the bathroom, touching anything dirty, after being in crowded areas or on public transport
  • try to avoid people with coughs, colds, or who might have infections or other bugs
  • take extra care when changing nappies, gardening, touching household or animal waste, and wash your hands after
  • take extra care with pets: wash your hands after touching them, avoid touching cat litter, and look after your animal's health
  • take care with food hygiene: you may want to avoid eating raw eggs or undercooked pâté, meat and poultry, as well as unpasteurised dairy products and soft or blue cheeses - you may be more open to the type of infections caused by bacteria, such as listeria, when being treated with adalimumab
  • take extra precautions when travelling to any countries or locations where food and water quality might not be up to the highest standards
  • be more active - regular exercise lowers blood pressure by keeping your heart and blood vessels in good condition; it does not need to be too energetic: walking every day is enough
  • eat healthily - aim to eat a diet that includes plenty of fruit and veg, wholegrains, fat-free or low-fat dairy products, and lean proteins
Can I have vaccinations?

If your immune system is affected by adalimumab, you're more at risk of infection caused by a live vaccine.

All live vaccinations (such as measles, mumps and rubella, shingles and some flu vaccines) use live viruses.

If you need to have a vaccine, you should check with your doctor, pharmacist or nurse whether it's a live vaccine and if there's an alternative inactivated vaccine available.