REMSIMA SOLUTION FOR SUBCUTANEOUS INJECTION 120 MG/ML IN PRE-FILLED PEN

INJECTION, SOLUTION

**4.2 Posology and method of administration** Remsima treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Remsima is indicated. Patients treated with Remsima should be given the patient information leaflet. Instruction for use is provided in the patient information leaflet. For subsequent injections and after proper training in subcutaneous injection technique, patients may self-inject with Remsima if their physician determines that it is appropriate and with medical follow-up as necessary. Suitability of the patient for subcutaneous home use should be assessed and patients should be advised to inform their healthcare professional if they experience symptoms of an allergic reaction before administering the next dose. Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). During Remsima treatment, other concomitant therapies, e.g., corticosteroids and immunosuppressants should be optimised. It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous) is being administered to the patient, as prescribed. Remsima subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only. Posology _Adults (≥18 years)_ _Rheumatoid arthritis_ Treatment with Remsima subcutaneous formulation should be initiated with loading doses of infliximab which may be intravenous or subcutaneous. When subcutaneous loading is used, Remsima 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 Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the second intravenous administration. The recommended maintenance dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. Remsima 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 (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Moderately to severely active Crohn’s disease_ Treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. If a patient does not respond within 2 weeks to the initial infusion, no additional treatment with infliximab should be given. _Fistulising Crohn’s disease_ Treatment with Remsima 120 mg administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. If a patient does not respond after 6 doses (i.e. 2 intravenous infusions and 4 subcutaneous injections), no additional treatment with infliximab should be given. _Ulcerative colitis_ Treatment with Remsima 120 mg administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. 2 intravenous infusions and 4 subcutaneous injections (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period. _Ankylosing spondylitis_ Treatment with Remsima 120 mg administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose of Remsima subcutaneous formulation is 120 mg once every 2 weeks. If a patient does not respond by 6 weeks (i.e. after 2 intravenous infusions), no additional treatment with infliximab should be given. _Psoriatic arthritis_ Treatment with Remsima 120 mg administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. _Psoriasis_ Treatment with Remsima 120 mg administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. If a patient shows no response after 14 weeks (i.e. 2 intravenous infusions and 5 subcutaneous injections), no additional treatment with infliximab should be given. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. _Re-administration for Crohn’s disease and rheumatoid arthritis_ 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 (see sections 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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. _Re-administration for ulcerative colitis_ From experience with intravenous infliximab, the safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Re-administration for ankylosing spondylitis_ From experience with intravenous infliximab, the safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Re-administration for psoriatic arthritis_ From experience with intravenous infliximab, the safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Re-administration for psoriasis_ Limited experience from retreatment with one single intravenous infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Switching to and from Remsima subcutaneous formulation across indications_ When switching from the maintenance therapy of infliximab intravenous formulation to the subcutaneous formulation of Remsima, the subcutaneous formulation may be administered 8 weeks after the last 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 Remsima. Information regarding switching patients from the subcutaneous formulation to the intravenous formulation of Remsima is not available. _Missed dose_ If patients miss an injection of Remsima 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 bi-weekly 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 bi-weekly dosing schedule. Special populations _Elderly_ 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 (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For more information about the safety of infliximab in elderly patients (see sections 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal and/or hepatic impairment_ Infliximab has not been studied in these patient populations. No dose recommendations can be made (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ The safety and efficacy of Remsima subcutaneous therapy in children aged below 18 years of age have not yet been established. No data are available. Therefore, subcutaneous use of Remsima is recommended for use only in adults. Method of administration Remsima 120 mg solution for injection in pre-filled syringe or in pre-filled pen are administered by subcutaneous injection only. Full instructions for use are provided in the patient information leaflet. 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 (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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.