Remicade infusion contains the active ingredient infliximab, which is a type of medicine called a monoclonal antibody. It works by suppressing part of the immune system and modifying the process of inflammation.
Monoclonal antibodies are manufactured antibodies that are specifically designed to recognise and bind to unique proteins in the body. Infliximab works by binding to and preventing the activity of a specific protein produced by the body, called tumour necrosis factor alpha (TNF alpha). TNF alpha is involved in producing inflammation. It controls the activity of other inflammatory chemicals.
TNF alpha is involved in various inflammatory conditions. It is found in the inflamed joints of people with rheumatoid arthritis. It is also involved in a form of arthritis affecting the spine, called ankylosing spondilitis, and a form of arthritis that affects the skin as well as the joints, called psoriatic arthritis.
TNF alpha is also found in the inflamed lining of the intestine of people with Crohn's disease and ulcerative colitis, and is also involved in plaque psoriasis.
By preventing the action of TNF alpha, infliximab prevents the inflammatory responses it causes. In all the conditions mentioned, it reduces the inflammation and related symptoms.
In arthritic conditions, treatment with infliximab 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.
In Crohn's disease and ulcerative colitis, treatment with infliximab reduces the movement of inflammatory cells into inflamed areas of the intestines. In ulcerative colitis it encourages ulcers on the walls of the intestines to heal.
In plaque psoriasis, infliximab reduces the skin inflammation and thickened scaly plaques of skin.
Infliximab is only given under the supervision of specialists in these diseases. It is given as a drip into a vein (intravenous infusion) over a two hour period. This is repeated two and six weeks after the first infusion and then at further intervals of six to eight weeks, depending on the condition treated and the response to the first doses.
Infliximab is used in combination with methotrexate, when disease modifiying antirheumatic drugs (DMARDs, eg sulfasalazine, methotrexate) have not been effective. It can also be used for people with severe active progressive rheumatoid arthritis who have not previously been treated with DMARDs.
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, raised markers of inflammatory activity, and who have responded inadequately to conventional therapy.
A form of arthritis affecting the joints and the skin (psoriatic arthritis).
Infliximab is used for active progressive disease that has not responded adequately to treatment with disease modifiying antirheumatic drugs (DMARDs, eg sulfasalazine, methotrexate). It can be used in combination with methotrexate, or on its own for people who cannot take methotrexate.
Infliximab is used to treat adults with this condition who have failed to respond to, or who cannot take other sytemic therapies including ciclosporin, methotrexate or PUVA.
Infliximab is used when conventional treatment with a corticosteroid and an immunosuppressant has been ineffective, or is not appropriate for the patient.
Infliximab is used when conventional treatment, including corticosteroids and mercaptopurine or azathioprine, has been ineffective, or is not 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.
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.
This medicine should not be used if you are allergic to one or 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.
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 individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or 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 side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
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