Active Ingredient: Infliximab
Infliximab, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
3 - 7.5 mg per kg of body weight
From 3 To 7.5 mg per kg of body weight once every 56 day(s)
3 mg per kg of body weight
3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Infliximab must be given concomitantly with methotrexate.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
If a patient has an inadequate response or loses response after this period, consideration may be given to increase the dose step-wise by approximately 1.5 mg/kg, up to a maximum of 7.5 mg/kg every 8 weeks. Alternatively, administration of 3 mg/kg as often as every 4 weeks may be considered. If adequate response is achieved, patients should be continued on the selected dose or dose frequency. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment or after dose adjustment.
If the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last infusion. In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year. The safety and efficacy of re-administration after an infliximab-free interval of more than 16 weeks has not been established. This applies to both Crohn’s disease patients and rheumatoid arthritis patients.
Infliximab should be administered intravenously over a 2 hour period. All patients administered infliximab are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available. Patients may be pre-treated with e.g. an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously.
Shortened infusions across adult indications
In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of infliximab (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour. If an infusion reaction occurs in association with a shortened infusion, a slower infusion rate may be considered for future infusions if treatment is to be continued. Shortened infusions at doses >6 mg/kg have not been studied.
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