How does it work?

Humira injection contains the active ingredient adalimumab,which is a type of medicine called a human monoclonal antibody. It works bysuppressing part of the immune system and modifying the process ofinflammation.

Adalimumab works in a similar way to the natural antibodiesproduced by our immune system. Our natural antibodies recognise foreigninvaders and bind to them, helping our immune systems to attack them andprotect us from infections. Monoclonal antibodies like adalimumab are made inlaboratories and are designed to recognise particular proteins in a similarway.

Adalimumab specifically recognises and binds to a proteinproduced by the body called tumour necrosis factor alpha (TNF alpha). TNF alphais involved in producing inflammation. It controls the activity of otherinflammatory chemicals.

TNF alpha is found in increased levels in various inflammatoryconditions. It is found in the inflamed joints of people with rheumatoidarthritis. It is also involved in a form of arthritis affecting the spine,called ankylosing spondilitis, and a form of arthritis, called psoriaticarthritis, that can occur in people with the skin condition psoriasis.

TNF alpha is also found in the inflamed lining of the intestineof people with Crohn's disease and in increased levels in skin affected by psoriasis.

By binding to TNF alpha, adalimumab prevents the inflammatoryresponses it causes. In all the conditions mentioned, it reduces theinflammation and related symptoms.

In arthritic conditions, treatment with adalimumab reduces themovement of inflammatory cells into inflamed areas of the joints. This reducesthe signs and symptoms of the arthritis, improves physical function of thejoints and reduces the rate of joint damage. It also reduces the presence ofother inflammatory markers. When treating arthritis, adalimumab is referred toas a disease-modifying antirheumatic drug or DMARD.

In Crohn's disease treatment with adalimumab reduces themovement of inflammatory cells into inflamed areas of the intestines.

Adalimumab is only prescribed by specialists in these diseases.It is administered as an injection under the skin (subcutaneously) once everyother week (or every week in some people with rheumatoid arthritis).

What is it used for?

• Moderate to severe rheumatoid arthritis.

Adalimumab is used in combination with methotrexate, when otherdisease modifiying antirheumatic drugs (DMARDs, eg sulfasalazine, methotrexate)have not been effective. It can also be used for people with severe activeprogressive rheumatoid arthritis who have not previously been treated withmethotrexate. Adalimumab can also be used on its own for people who can’t takemethotrexate, or when continued treatment with methotrexate isinappropriate.

• A form of arthritis that occurs predominantly in young men and affects the joints of the spine (ankylosing spondylitis).

Adalimumab is used for people who have severe symptoms of thiscondition and who have responded inadequately to conventionaltherapy.

• A form of arthritis, called psoriatic arthritis that can occur in people with the skin condition psoriasis.

Adalimumab is used for patients with active progressive diseasethat has not responded to treatment with other disease modifiying antirheumaticdrugs (DMARDs, eg sulfasalazine, methotrexate).

• Moderate to severe chronic plaque psoriasis.

Adalimumab is used for people whose psoriasis has not responded to other systemic therapy including ciclosporin, methotrexate or PUVA, and for people who cannot take these types of treatments.

• Severe active Crohn's disease.

Adalimumab is used for people with this condition who have notresponded well to a full course of therapy with a corticosteroid and/or animmunosuppressant medicine, or who cannot take these medicines. Initiallyadalimumab should be used in combination with corticosteroids, however, if thepatient cannot tolerate corticosteroids or they are not appropriate thenadalimumab can be used on its own.

Warning!

• This medicine can compromise the body's ability to fight infections. Cases of tuberculosis (TB) and other serious infections have been seen in people treated with this medicine. You should be tested for TB before treatment is started. Tell your doctor immediately if you experience weight loss, fever or persistent coughing during treatment, as these can be symptoms of TB.
• It is important to try and avoid exposure to infections during your treatment. Let your doctor know as soon as possible if you get any symptoms of any infection, so that it can be treated without delay. This also applies for five months after you stop using this medicine, as this is how long it may take for the medicine to be fully removed from the body. If you develop a serious infection, treatment with this medicine should be stopped until the infection is controlled.
• On rare occasions, this medicine may decrease the number of blood cells in the blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you should tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) other signs of infection, or looking pale, feeling tired, breathless, or generally unwell. Your doctor may need to take a blood test to check the levels of blood cells in your blood.
• If you develop shortness of breath or swelling of your feet or ankles during treatment with this medicine you should tell your doctor.
• Consult your doctor immediately if you experience any of the following symptoms while receiving treatment with this medicine: unexplained confusion, numbness, changes in vision or difficulty walking.
• If you are due to have any surgery or dental procedures, it is important to tell your doctor or dentist that you are having treatment with this medicine.
• Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment with this medicine and for at least five months after their last injection. Seek medical advice from your doctor.
• Humira should be stored in a refrigerator at 2°C – 8°C. Keep the pre-filled pen or the pre-filled syringe in the outer carton. Do not freeze.

Use with caution in

• Decreased kidney function.
• Decreased liver function.
• History of hepatitis B.
• Dormant (currently inactive) tuberculosis infection.
• History of recurrent infections.
• People who are or who have recently been receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy, medicines to prevent transplant rejection.
• Mild heart failure.
• Demyelinating disorders such as multiple sclerosis.
• Swelling of the optic nerve resulting in blurring of vision (optic neuritis).
• People who are due to have a joint surgically repaired.
• History of or current cancer.
• Heavy smokers.
• Allergy to latex (the needle cover of the syringe contains latex).

Not to be used in

• Children.
• Active tuberculosis.
• Severe infections, eg abscesses, leg ulcers.
• Infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis).
• Infections due to lowered resistance of the body (opportunistic infections).
• Moderate to severe heart failure.
• Pregnancy.
• Breastfeeding.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• There is no information about the safety of this medicine during pregnancy. It is not recommended for use during pregnancy as it could potentially be harmful to a developing baby. Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment and for at least five months after their last injection. If you think you could be pregnant at any point during treatment you should tell your doctor straight away. Seek further medical advice from your doctor.
• It is not known if this medicine passes into breast milk, however it is likely that it does. Women should not breastfeed during treatment with this medicine, or for five months after their last dose. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

• Bacterial, viral or fungal infections, sometimes serious.
• Reactions such as pain, swelling, redness or itching at the injection site.
• Headache.
• Dizziness.
• Pins and needles or numb sensations.
• Increased blood pressure.
• Cough.
• Nasal congestion.
• Fatigue.
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting, indigestion or abdominal pain.
• Mouth ulcers.
• Decreased numbers of red blood cells, white blood cells or platelets in the blood.
• Skin reactions such as rash or itching.
• Hair loss.
• Loss of appetite.
• Taste disturbances.
• Depression or anxiety.
• Difficulty sleeping (insomnia) or feeling sleepy.
• Eye disorders.
• Shortness of breath.
• New or worsening heart failure.
• Nerve disorders.

The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

Since this is a relatively new medicine, there is limitedinformation about its potential interactions with other medicines. You shouldtell your doctor if you are taking any other medicines, includingover-the-counter and herbal medicines, before you start treatment with thismedicine. Similarly, always seek advice from your doctor or pharmacist beforetaking any new medicines while you are receiving treatment with this medicine,so they can check that thecombination is safe.

Adalimumab is not recommended for use in combination withanakinra, as this combination may increase the risk of serious infections,without an increase in efficacy against the disease treated.

This medicine suppresses part of the immune system. This meansthat vaccines may potentially be less effective if given during treatment, andlive vaccines may cause serious infections. Live vaccines include: measles,mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. It isrecommended that live vaccines are not given to people being treated with thismedicine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain adalimumab as the active ingredient.