Active Ingredient: Infliximab
Infliximab is indicated for treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and 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 infusions at 2 and 6 weeks after the first infusion. If a patient does not respond after 3 doses, no additional treatment with infliximab should be given.
In responding patients, the alternative strategies for continued treatment are:
Although comparative data are lacking, limited data in patients who initially responded to 5 mg/kg but who lost response indicate that some patients may regain response with dose escalation. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
In Crohn's disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
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.
In case maintenance therapy is interrupted, and there is a need to restart treatment, use of a re-induction regimen is not recommended. In this situation, infliximab should be re-initiated as a single dose followed by the maintenance dose recommendations described above.
Specific studies of infliximab in elderly patients have not been conducted. No major age-related differences in clearance or volume of distribution were observed in clinical studies. No dose adjustment is required.
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.
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.
For:
Subcutaneous, 120 milligrams infliximab, once every 2 weeks.
The first treatment with infliximab administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of intravenous infusions. Before initiating treatment with infliximab subcutaneous formulation, 2 intravenous infusions of infliximab 5 mg/kg should be given at 2 weeks apart, and an additional intravenous infusion of infliximab 5 mg/kg may be given 4 weeks after the second infusion. The recommended maintenance dose for infliximab subcutaneous formulation is 120 mg once every 2 weeks. If a patient does not respond after loading doses of intravenous infliximab, no additional treatment with infliximab should be given. Available data do not support further infliximab treatment, in patients not responding within 14 weeks of the initial infusion.
Limited data in patients who initially responded to induction regimen with infliximab but who lost response indicate that some patients may regain response with dose escalation. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
In Crohn's disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
From experience with intravenous infliximab, if the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last administration. In clinical studies with intravenous infliximab, 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.
In case maintenance therapy is interrupted, and there is a need to restart treatment, use of a re-induction regimen of intravenous infliximab is not recommended. In this situation, infliximab should be re-initiated as a single dose of intravenous infliximab followed by the maintenance dose recommendations of subcutaneous infliximab described above given 4 weeks after the last administration of intravenous infliximab.
When switching from the maintenance therapy of infliximab intravenous formulation to the subcutaneous formulation of infliximab, the subcutaneous formulation may be administered at the time of next planned administration of the intravenous infusions of infliximab.
There is insufficient information regarding the switching of patients who received the intravenous infusions of infliximab higher than 3 mg/kg for rheumatoid arthritis or 5 mg/kg for Crohn's disease every 8 weeks to the subcutaneous formulation of infliximab.
Information regarding switching patients from the subcutaneous formulation to the intravenous formulation of infliximab is not available.
If patients miss an injection of infliximab subcutaneous formulation, they should be instructed to take the missed dose immediately in case this happens within 7 days from the missed dose, and then remain on their original dosing schedule. If the dose is delayed by 8 days or more, the patients should be instructed to skip the missed dose, wait until their next scheduled dose, and then remain on their original dosing schedule.
Specific studies of infliximab in elderly patients have not been conducted. No major age-related differences in clearance or volume of distribution were observed in clinical studies with infliximab intravenous formulations and the same is expected for subcutaneous formulation. No dose adjustment is required.
For the two initial intravenous infusions, 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. The physician should ensure appropriate follow-up of patients for any systemic injection reaction and localised injection site reaction after the initial subcutaneous injection is administered.
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