How does it work?

Orencia infusion contains the active ingredient abatacept, which is a type of medicine called a selective immunosuppressant. It is used to treat severe forms of rheumatoid arthritis. Rheumatoid arthritis is known as an autoimmune disease, because the inflammation and damage to the joints results from overactivity in the immune system. Abatacept works by suppressing part of the immune system and modifying the process of inflammation.

Abatacept works by binding to cells called antigen presenting cells, which are important cells in the immune system. By binding to the surface of these, abatacept prevents them from binding with other important immune cells called T-lymphocytes. Normally when antigen presenting cells bind with T-lymphocytes, this activates the T-cells, setting off a chain reaction that results in inflammation.

The activated T-lymphocytes multiply in numbers and directly cause inflammation themselves. They also produce substances that cause inflammation, such as interleukins and TNF alfa, as well as activating other inflammatory cells.

By preventing the antigen presenting cells from binding to the T lymphocytes, abatacept stops them activating the T-lymphocytes. This stops the T-lymphocytes from producing these inflammatory responses.

In arthritic conditions, treatment with abatacept reduces the movement of inflammatory cells into inflamed areas of the joints. This reduces the signs and symptoms of the arthritis, improves physical function of the joints and reduces the rate of joint damage. It also reduces the presence of other inflammatory markers. When treating arthritis, abatacept is referred to as a disease-modifying antirheumatic drug or DMARD.

Abatacept is only given under the supervision of specialists. It is given as a drip into a vein (intravenous infusion) over a 30 minute period. This is repeated two and four weeks after the first infusion and then at further intervals of four weeks. If no improvements in symptoms have been seen after six months, it may be necessary to stop the treatment.

What is it used for?

• Moderate to severe rheumatoid arthritis.
• Arthritis with no known cause affecting several joints, in children aged six years and over (polyarticular juvenile idiopathic arthritis).

Abatacept is used in combination with methotrexate, when otherdisease modifiying antirheumatic drugs (DMARDs, eg sulfasalazine, infliximab)have not been effective or are not tolerated. This medicinehas not been studied in children under six years of age.

Warning!

• This medicine can compromise the body's ability to fight infections. Cases of other serious infections, including tuberculosis (TB), 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. If you develop a serious infection, treatment with this medicine should be stopped until the infection is controlled.
• 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 14 weeks after their last treatment. Seek medical advice from your doctor.
• This medicine contains maltose, which is a type of sugar that can give a falsely high blood glucose reading with certain types of blood glucose monitors. Your doctor or pharmacist will be able to check this for you.

Use with caution in

• Elderly people.
• Carriers 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.
• Multiple sclerosis.
• History of or current cancer.
• People on a low sodium diet.

Not to be used in

• Active tuberculosis.
• Severe and uncontrolled infections.
• 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).
• Breastfeeding.
• This medicine is not recommended for children under six years of age.

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

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

Pregnancy and breastfeeding

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

• The safety of this medicine for use during pregnancy has not been established. The manufacturer states that it should not be used during pregnancy unless considered essential by your doctor. Women who could get pregnant should use effective contraception to avoid pregnancy during treatment, and for at least 14 weeks after their last treatment.
• It is not known whether this medicine passes into breast milk. Women should not breastfeed during treatment with this medicine, or for at least 14 weeks after their last dose.

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.

Very common (affect more than 1 in 10 people)

• Headache.

Common (affect between 1 in 10 and 1 in 100 people)

• Increase in blood pressure.
• Alteration in results of liver function tests.
• Dizziness.
• Cough.
• Disturbances of the gut such as diarrhoea, indigestion, nausea, vomiting or abdominal pain.
• Flushing.
• Skin reactions, such as itchy rash, dermatitis.
• Fatigue, weakness or loss of strength (asthenia).
• Respiratory tract infections, such as bronchitis.
• Urinary tract infections.
• Cold sores.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Decrease in blood pressure.
• Hot flushes.
• Weight gain.
• Faster or slower than normal heart rate.
• Palpitations.
• Pins and needles sensations (paraesthesia).
• Decrease in the number of white blood cells or platelets in the blood (leucopenia or thrombocytopenia).
• Conjunctivitis.
• Inflammation of the lining of the mouth (stomatitis) or mouth ulcers.
• Increased hair loss (alopecia).
• Dry skin.
• Increased tendency to bruise.
• Sensation of spinning (vertigo).
• Tightness of the throat.
• Tooth infection.
• Infected skin ulcers.
• Flu-like symptoms.
• Stopping of menstrual periods.
• Depression, anxiety.
• Joint pain (arthralgia).
• Migraine.
• Pneumonia.
• Nettle-type rash.
• Basal cell carcinoma.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Infection of the blood or body tissues with pus-forming or other pathogenic organisms (sepsis).

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

For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Abatacept is not recommended for use with the following medicines, as the combination may increase the risk of serious infections, without an increase in effectiveness against arthritis:

• adalimumab
• anakinra
• etanercept
• infliximab
• rituximab.

There may be an increased risk of infections if this medicine is used to treat 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 or medicines to prevent transplant rejection.

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 or within three months of stopping this medicine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain abatacept as the active ingredient.