Remsima 120 mg Dosage/Direction for Use

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 package leaflet and the patient reminder card. Instruction for use is provided in this monograph.
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 Precautions).
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 administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 3 mg/kg given 2 weeks apart. The recommended 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 Pharmacology: Pharmacodynamics under Actions).
Re-administration for 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 Precautions and Adverse Reactions). The safety and efficacy of re-administration after an infliximab-free interval of more than 16 weeks has not been established. This applies to rheumatoid arthritis patients.
Re-administration across indications: 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 (see Adverse Reactions). In this situation, infliximab should be re-initiated as a single dose of Remsima subcutaneous formulation followed by the maintenance dose recommendations described previously.
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 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 Pharmacology: Pharmacokinetics under Actions). For more information about the safety of infliximab in elderly patients, see Precautions and Adverse Reactions.
Renal and/or hepatic impairment: Infliximab has not been studied in these patient populations. No dose recommendations can be made (see Pharmacology: Pharmacokinetics under Actions).
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 pen are administered by subcutaneous injection only. Full instructions for use are provided in the package 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 Precautions). 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.