How does it work?

Remicade infusion contains the active ingredient infliximab,which is a type of medicine called a monoclonal antibody. It works bysuppressing part of the immune system and modifying the process ofinflammation.

Monoclonal antibodies are manufactured antibodies that arespecifically designed to recognise and bind to unique proteins in the body.Infliximab works by binding to and preventing the activity of a specificprotein produced by the body, called tumour necrosis factor alpha (TNF alpha).TNF alpha is involved in producing inflammation. It controls the activity ofother inflammatory chemicals.

TNF alpha is involved in various inflammatory conditions. It isfound in the inflamed joints of people with rheumatoid arthritis. It is alsoinvolved in a form of arthritis affecting the spine, called ankylosingspondilitis, and a form of arthritis that affects the skin as well as thejoints, called psoriatic arthritis.

TNF alpha is also found in the inflamed lining of the intestineof people with Crohn's disease and ulcerative colitis, and is also involved inplaque psoriasis.

By preventing the action of TNF alpha, infliximab prevents theinflammatory responses it causes. In all the conditions mentioned, it reducesthe inflammation and related symptoms.

In arthritic conditions, treatment with infliximab 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.

In Crohn's disease and ulcerative colitis, treatment withinfliximab reduces the movement of inflammatory cells into inflamed areas ofthe intestines. In ulcerative colitis it encourages ulcers on the walls of theintestines to heal.

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

Infliximab is only given under the supervision of specialists inthese diseases. It is given as a drip into a vein (intravenous infusion) over atwo hour period. This is repeated two and six weeks after the first infusionand then at further intervals of six to eight weeks, depending on the conditiontreated and the response to the first doses.

What is it used for?

• Rheumatoid arthritis.

Infliximab is used in combination with methotrexate, whendisease 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 withDMARDs.

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

Infliximab is used for patients who have severe symptoms and who have responded inadequately toconventional therapy.

• A form of arthritis affecting the joints and the skin (psoriatic arthritis).

Infliximab is used for active progressive disease that has notresponded adequately to treatment with disease modifiying antirheumatic drugs(DMARDs, eg sulfasalazine, methotrexate). It can be used in combination withmethotrexate, or on its own for people who cannot takemethotrexate.

• Moderate to severe plaque psoriasis.

Infliximab is used to treat adults with this condition who havefailed to respond to, or who cannot take other sytemic therapies includingciclosporin, methotrexate or PUVA.

• Severe active Crohn's disease in adults and children aged six years and over.

Infliximab is used when conventional treatment with acorticosteroid and an immunosuppressant has been ineffective, or is notappropriate for the patient.

• Crohn's disease with fistula formation.

Infliximab is used for people who have not responded toconventional treatment, including antibiotics, drainage and immunosuppressivetherapy.

• Moderate to severe active ulcerative colitits.

Infliximab is used when conventional treatment, includingcorticosteroids and mercaptopurine or azathioprine, has been ineffective, or isnot appropriate for the patient.

Warning!

• Allergic reactions may develop during or within two hours of infliximab infusion. This is most likely to occur during the first and second infusions. The reactions may be mild, or more severe requiring medical treatment and discontinuation of the infusion. Your doctor can explain more about this. You may be given medicines such as hydrocortisone, paracetamol or an antihistamine before the infusion to prevent allergic reactions. All people receiving infliximab infusions must be medically observed for one to two hours following the infusion in case these reactions develop.
• Administration of this medicine after prolonged periods without treatment can cause a delayed allergic reaction. Symptoms of delayed allergic reactions include muscle and/or joint pain with fever and/or rash, itching, swelling of the hands, lips or face, difficulty swallowing, nettle-type rash, sore throat and/or headache. You should seek immediate medical advice if you experience any of these symptoms. If you have not received an infusion for 16 weeks or more, further readministration is not recommended.
• This medicine can compromise the body's ability to fight infections, and cases of tuberculosis (TB) have been seen. For this reason, you should be tested for TB prior to treatment. Tell your doctor immediately if you experience persistent coughing, weight loss or fever, as these can be symptoms of TB. It is important to try and avoid exposure to infections during your treatment. Let your doctor as soon as possible if you get any symptoms of any infection so that it can be treated without delay. This applies for up to six months after finishing treatment, as this is how long it may take for the medicine to be removed from the body. Be aware that this medicine can mask some of the usual symptoms of infection, such as a high temperature (fever), so it is important to be extra vigilant. If you develop a serious infection, further treatment with this medicine should not be given.
• 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.
• This medicine may very rarely cause liver problems. Consult your doctor promptly if you develop unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms.
• If you are due to have any surgery or dental procedures, it is important to inform your doctor or dentist that you are having treatment with this medicine.
• Women who could get pregnant should use effective contraception to prevent pregnancy both during treatment with this medicine, and for at least six months after their last treatment. Seek medical advice from your doctor.

Use with caution in

• Elderly people.
• Liver disease.
• Carriers of hepatitis B.
• Kidney disease.
• 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.
• Multiple sclerosis.
• Swelling of the optic nerve which results in blurring of vision (optic neuritis).
• People who have had a joint surgically repaired.
• History of or current cancer.
• Heavy smokers.
• Psoriasis patients who have had extensive immunosuppressant therapy or prolonged PUVA treatment.
• Ulcerative colitis patients who have had the disease for several years, or who have a history of cell changes or colon cancer.

Not to be used in

• Allergy to mouse protein.
• Tuberculosis.
• Severe infections, eg abscesses.
• 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 one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor 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, and it is not recommended for use during pregnancy. Women who could get pregnant should use effective contraception to avoid pregnancy during treatment, and for at least six months 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 six months 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.

• Bacterial, viral or fungal infections, sometimes serious.
• Headache.
• Dizziness or loss of balance.
• Difficulty in breathing (dyspnoea).
• Flushing.
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
• Itchy rash (urticaria).
• Increased sweating.
• Fatigue.
• Chest pain.
• Depression.
• Confusion.
• Agitation.
• Memory loss.
• Disturbance in the normal numbers of blood cells in the blood.
• Abnormal heart beats (arrhythmias).
• Fainting.
• Pain in the muscles and joints.
• Worsening heart failure.
• Lupus syndrome.
• Allergic reactions.
• Injection site reactions.
• Changes in blood pressure.
• Liver disorders.

The side effects listed above may not include all of the sideeffects reported by the drug'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?

Since this is a relatively new medicine, there is limitedinformation about its potential interactions with other medicines. Always tellyour doctor if you are taking any other medicines, including over-the-counterand herbal medicines, before starting treatment with infliximab. Similarly,always seek advice from your doctor or pharmacist before taking any newmedicines while you are receiving treatment with infliximab, so they can checkthat thecombination is safe.

Infliximab 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 infliximab as the active ingredient.