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Indications Dosing Administration Device Safety Information

Dosing

  • Dosing schedules1

    When initiating with Remsima® SC

    • 4 weeks after the last administration of the infliximab intravenous
    • Bi-weekly administration of Remsima® SC

    When switching from infliximab IV maintenance therapy

    • 8 weeks after the last administration of the infliximab intravenous
    • Bi-weekly administration of Remsima® SC
  • Important dosing information1

    MISSED
    DOSE
    Missed dose for up to 7 days

    If patients miss an injection of Remsima® SC, 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.1

    Missed dose for 8 days or more

    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.1

    RE-
    ADMINISTRATION
    Re-administration across indications

    In case maintenance therapy is interrupted, infliximab should be re-initiated as a single dose of intravenous infliximab followed by the maintenance dose commendations of subcutaneous infliximab described above given 4 weeks after the last administration of intravenous infliximab.

  • Special populations1

    • No dose adjustment is required in elderly patients (65+)

    • Safety and efficacy not established for children and adolescents under age 18

  • Dosing for each indication1

      Moderately to Severely Active Crohn’s Disease

      Posology

      * Available data do not support further infliximab treatment, in patients not responding within 6 weeks of the initial infusion.
      * Q2W, Every two weeks

      Re-administration for Crohn’s Disease

      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.

      Fistulising, Active Crohn’s Disease

      Posology

      * 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.
      * Q2W, Every two weeks

      Re-administration for Crohn’s Disease

      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.

      Moderately to Severely Active Ulcerative Colitis

      Posology

      * Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. 2 intravenous infusions and 4 subcutaneous injections.
      Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
      * Q2W, Every two weeks

      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.

      Severe, Active Ankylosing Spondylitis

      Posology

      * If a patient does not respond by 6 weeks (i.e. after 2 intravenous infusions), no additional treatment with infliximab should be given.
      * Q2W, Every two weeks

      Re-administration for Ankylosing Spondylitis

      From experience with intravenous infliximab, the safety and efficacy of re-administration, other than 6 to 8 weeks, has not been established.

      Moderately to Severely Active Rheumatoid Arthritis

      Posology

      Must be given concomitantly with MTX.

      * Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment
      * Q2W, Every two weeks; MTX, methotrexate

      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.

      Active and Progressive Psoriatic Arthritis

      Posology

      Should be administered in combination with MTX or alone in patients with Intolerance or contraindications to MTX.

      * Q2W, Every two weeks; MTX, methotrexate

      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.

      Moderately to Severe Plaque Psoriasis

      Posology

      * If a patient does not respond by 14 weeks (i.e. 2 intravenous infusions abd 5 subcutaneous injections), no additional treatment with Infliximab should be given.
      * Q2W, Every two weeks

      Re-administration for Plaque Psoriasis

      Limited experience from re-treatment 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.

References

1. Remsima® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/Remsima®-epar-product-information_en.pdf Accessed 4 Sep 2020.

Abbreviations

IFX, infliximab; IV, intravenous; MTX, methotrexate; SC, subcutaneous; Q2W, Every two weeks;