Active Ingredient: Infliximab
Infliximab is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 5 milligrams infliximab per kilogram of body weight, one dose, over the duration of 2 weeks. Afterwards, intravenous, 5 milligrams infliximab per kilogram of body weight, one dose, over the duration of 4 weeks. Afterwards, intravenous, 5 milligrams infliximab per kilogram of body weight, once every 8 weeks.
5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Available data do not support further infliximab treatment in children and adolescents not responding within the first 10 weeks of treatment.
Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient. Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions. Continued therapy with a shortened interval should be carefully considered in those patients who show no evidence of additional therapeutic benefit after a change in dosing interval.
The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years.
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.
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