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:
For:
Intravenous, 3 milligrams infliximab per kilogram of body weight, one dose, over the duration of 2 weeks. Afterwards, intravenous, 3 milligrams infliximab per kilogram of body weight, one dose, over the duration of 4 weeks. Afterwards, intravenous, 3 milligrams infliximab per kilogram of body weight, once every 8 weeks.
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.
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:
Regimen A
Subcutaneous, 120 milligrams infliximab, once weekly, 5 doses in total, over the duration of 4 weeks. Afterwards, subcutaneous, 120 milligrams infliximab, once every 2 weeks.
Regimen B
Intravenous, 3 milligrams infliximab per kilogram of body weight, one dose, over the duration of 2 weeks. Afterwards, intravenous, 3 milligrams infliximab per kilogram of body weight, one dose, over the duration of 4 weeks. Afterwards, subcutaneous, 120 milligrams infliximab, once every 2 weeks.
Treatment with infliximab subcutaneous formulation should be initiated with loading doses of infliximab which may be intravenous or subcutaneous. When subcutaneous loading is used, infliximab 120 mg should be given as a subcutaneous injection followed by additional subcutaneous injections at 1, 2, 3 and 4 weeks after the first injection, then every 2 weeks thereafter. If intravenous loading doses of infliximab are given to initiate treatment, 2 intravenous infusions of infliximab 3 mg/kg should be given 2 weeks apart. The first treatment with infliximab administered subcutaneously should be initiated as maintenance therapy 4 weeks after the second intravenous administration. The recommended maintenance dose for infliximab subcutaneous formulation is 120 mg once every 2 weeks.
Infliximab must be given concomitantly with methotrexate.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment.
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. This applies to both Crohn's disease patients and rheumatoid arthritis patients.
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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