REMSIMA® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

**Dosage and Administration** REMSIMA® treatment is to be administered under the supervision and monitoring of specialized physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis. REMSIMA® should be administered intravenously. During REMSIMA® treatment, other concomitant therapies, e.g., corticosteroids and immunosuppressants should be optimized. **Adults (≥ 18 years)** _**Rheumatoid Arthritis**_ 3 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. 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 this time period. _**Moderately to Severely, Active Crohn’s Disease**_ 5 mg/kg given as an intravenous infusion over a 2-hour period. Available data do not support further infliximab treatment, in patients not responding within 2 weeks to the initial infusion. In responding patients, the strategy for continued treatment is. - Maintenance: Additional infusions of 5 mg/kg at 2 and 6 weeks after the initial dose, followed by infusions every eight weeks. _**Fistulising Crohn’s Disease**_ An initial 5 mg/kg infusion given over a 2-hour period is to be followed with additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion. If a patient does not respond after these 3 doses, no additional treatment with infliximab should be given. In responding patients, the strategies for continued treatment are: - Additional infusions of 5 mg/kg every 8 weeks or - Readministration if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see _Readministration_ below and _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Ulcerative Colitis**_ 5mg/kg given as intravenous infusion over a 2-hour period followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. three doses. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period. _**Ankylosing Spondylitis**_ 5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. If a patient does not respond by 6 weeks (i.e. after 2 doses), no additional treatment with infliximab should be given. _**Psoriatic Arthritis**_ 5 mg/kg given as intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Efficacy and safety have been demonstrated in combination with methotrexate. _**Psoriasis**_ 5mg/kg given as intravenous over a 2-hour period followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment with infliximab should be given. _**Readministration for Crohn’s Disease and Rheumatoid Arthritis**_ If the signs and symptoms of disease recur, REMSIMA® can be readministered within 16 weeks following the last infusion. In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after drug free intervals of less than 1 year (see _Warnings and Precautions_ and _Adverse Reactions: Delayed Hypersensitivity_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). After a drug free interval of 16 weeks to 2 years, the risk of delayed hypersensitivity following readministration is not known. Therefore, after a drug free interval of 16 weeks, readministration is not recommended. _**Readministration for Ulcerative Colitis**_ The safety and efficacy of readministration, other than every 8 weeks, has not been established. (see _Warnings and Precautions_ and _Adverse Reactions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_Readministration for Ankylosing Spondylitis_** The safety and efficacy of readministration, other than every 6 to 8 weeks, has not been established. (see _Warnings and Precautions_ and _Adverse Reactions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Readministration for Psoriatic Arthritis**_ The safety and efficacy of readministration, other than every 8 weeks, has not been established. (see _Warnings and Precautions_ and _Adverse Reactions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Readministration for Psoriasis**_ Limited experience from retreatment with one single 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 _Pharmacodynamic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Pediatrics** **_Crohn’s Disease (6 to 17 years)_** 5mg/kg given as intravenous infusion over a 2-hour period followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. For some patients a longer dosing interval may be sufficient. Available data do not support further infliximab treatment in paediatric patients not responding within the first 10 weeks of treatment. Pediatric Crohn’s disease patients who have had their dose adjusted to greater than 5 mg/kg every 8 weeks, may be at greater risk for adverse reactions. Continued therapy with the adjusted dose should be carefully considered in patients who show no evidence of additional therapeutic benefit after dose adjustment. _**Ulcerative Colitis (6 to 17 years)**_ 5mg/kg given as intravenous infusion over a 2-hour period followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. **Administration** REMSIMA® should be administered intravenously over a 2-hour period. All patients administered REMSIMA® 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 (see _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Shortened Infusions Across Adult Indications**_ In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of REMSIMA® (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 >6mg/kg have not been studied. For preparation and administration instructions, see _Instructions for Use and Handling and Disposal_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.