How does it work?

Enbrel injection contains the active ingredient etanercept,which is a type of medicine called a TNF blocker. It works by suppressing theprocess of inflammation.

Tumour necrosis factor alpha (TNF alpha) is a protein producedby the body that is involved in causing inflammation. It controls the activityof other inflammatory chemicals.

TNF alpha is found in increased levels in various inflammatoryconditions. It is found in the inflamed joints of people with rheumatoidarthritis and in the joints of people a form of arthritis affecting the spine,called ankylosing spondylitis. It is also found in increased levels in skinaffected by psoriasis, as well as in the joints of people with a form ofarthritis called psoriatic arthritis, which can occur in people with psoriasis.

To cause inflammation, TNF alpha has to act on TNF receptorsthat are found on the surface of cells. Etanercept works by stopping TNF alphafrom acting on these receptors. This prevents the inflammatory responses TNFcauses. In all the conditions mentioned, etanercept reduces the inflammationand related symptoms.

In arthritic conditions, treatment with etanercept 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, etanercept is referred toas a disease-modifying antirheumatic drug or DMARD.

In plaque psoriasis, etanercept reduces the skin inflammationand thickened scaly plaques of skin.

Etanercept is only prescribed by specialists in these diseases.It is administered as an injection under the skin (subcutaneously) once ortwice a week, depending on the condition being treated.

What is it used for?

• Moderate to severe rheumatoid arthritis.

Etanercept is used in combination with methotrexate, when otherdisease modifying 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. Etanercept can also be used on its own for people who can’t takemethotrexate, or when continued treatment with methotrexate isinappropriate.

• Arthritis with no known cause affecting several joints, in children aged 4 to 17 years (polyarticular juvenile idiopathic arthritis).

Etanercept is used to treat children with this condition whenmethotrexate has not been effective or has caused unacceptable side effects. Ithas not been studied in children under four years of age.

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

Etanercept is used for adults 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.

Etanercept is used for adults with active progressive diseasethat has not responded to treatment with other disease modifying antirheumaticdrugs (DMARDs, eg sulfasalazine, methotrexate).

• Moderate to severe plaque psoriasis.

Etanercept is used to treat psoriasis in adults and children over eight years of age who havefailed to respond to, or who cannot take other systemic therapies, includingciclosporin, methotrexate or PUVA.

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. It is very important to tell your doctor if you have ever had tuberculosis or have been in contact with someone who has tuberculosis. 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, in particular chickenpox, 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. If you develop a serious infection, treatment with this medicine should be stopped until the infection is controlled. If you or your child has been exposed to chickenpox you should let your doctor know straight away, as he may need to stop your treatment temporarily and administer antibodies to prevent the infection. Your doctor may want to continue to monitor you for infections for a period of time after treatment with this medicine is stopped.
• 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 during treatment with this medicine. Ask your doctor for further advice.
• Enbrel should be stored in a refrigerator at 2°C – 8°C. Do not freeze.

Use with caution in

• 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).
• People at risk of infections.
• History of decreases in the numbers of blood cells in the blood.
• Advanced or poorly controlled diabetes.
• History of hepatitis B or C.
• Heart failure.
• Demyelinating disorders such as multiple sclerosis.
• Swelling of the optic nerve resulting in blurring of vision (optic neuritis).
• Inflammation of the spinal cord (transverse myelitis).
• Allergy to latex (the needle cover of the syringe contains latex).

Not to be used in

• Active tuberculosis.
• Infections due to lowered resistance of the body (opportunistic infections).
• Infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis) and people at risk of sepsis.
• Any other active infections, including long-term or localised infections.
• Pregnancy.
• Breastfeeding.

This medicine should not be used if you are allergic to one orany 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 during treatment. 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. For this reason, women having treatment with this medicine should not breastfeed. 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 that orany side effect.

• Bacterial, viral or fungal infections, sometimes serious (see warning section above).
• Reactions such as pain, swelling, redness, bruising, bleeding or itching at the injection site.
• Allergic reactions.
• Skin reactions such as rash or itching.
• Fever.
• Decreased numbers of red blood cells, white blood cells or platelets in the blood (see warning section above).
• Nerve disorders.
• Seizures.
• Asthma or shortness of breath.
• New or worsening heart failure.
• Chest pain.
• Fainting.
• Pins and needles or numb sensations.
• Increased or decreased blood pressure.
• Depression.
• Confusion.
• Inflammation of the pancreas (pancreatitis).
• Bleeding from the gut.
• Blood clot in a blood vessel (deep vein thrombosis or pulmonary embolism).
• Kidney problems.

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.

Etanercept 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.

Etanercept is not recommended for use in combination with abatacept, as this combination may increase the risk of side effects,without an increase in efficacy against the disease treated.

There may be an increased chance of a fall in the numbers of white blood cells in the blood if etanercept is used in combination with sulfasalazine.

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. Where possible, children receiving this medicine should have alltheir recommended childhood vaccinations brought up to date before treatmentwith this medicine is started.

Other medicines containing the same active ingredient

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