Remicade

What is it?

A preparation of monoclonal antibody available as a powder containing 100mg of infliximab in vials, for reconstitution.

Medical Uses

Severe and active Crohn's disease, fistulising Crohn's disease in patients whose condition has failed to respond to treatment with corticosteroids and/or immunosuppressants. Combined with methotrexate, for rheumatoid arthritis which has not responded to other drugs.

Dosage

Adults and those aged over 17 years, for active Crohn's disease, 5mg per kg of body weight by intravenous infusion given over 2 hours. Fistulising Crohn's disease, same dose, then repeated after 2 weeks and 6 weeks. If necessary, a further infusion can be given within 14 weeks of last treatment. Rheumatoid arthritis, 3mg per kg of body weight by intravenous infusion over 2 hours, repeated after 2 weeks and 6 weeks and then every 8 weeks, with methotrexate given at same time.

Special Care

Elderly, liver or kidney disease. Patients should be screened for active and latent tuberculosis before and during treatment and re-assessed if latent disease is discovered. In event of active TB, treatment should be withdrawn. Patients must be monitored for acute allergic reactions while receiving infusion and for 2 hours afterwards, with emergency equipment being on hand. If necessary, infusion rate should be slowed or treatment discontinued. Delayed hypersensitivity reactions are possible hence periods between infusions must not exceed 15 weeks. Treatment should be withdrawn in event of symptoms of lupus. Women should use reliable contraception and avoid pregnancy or breastfeeding for 6 months after treatment has stopped.

Avoid Use

Children, pregnancy, breasfeeding, allergy to mouse protein, tuberculosis, sepsis, abscess or other opportunistic infections.

Known Side Effects

Gastrointestinal upset, fatigue, pains in chest, dizziness, fever, vertigo, viral infections, headaches, flushing, abnormal liver function, respiratory tract and urinary tract infections, shortness of breath, sinusitis. Any adverse side effects should be reported to the Committee on the Safety of Medicines (CSM).