The content provided by this website is intended only for Australian healthcare professionals.
Please leave this site if you are not an Australian healthcare professional.
-
Dosing schedules for using subcutaneous Remsima® in adults1
When initiating with Remsima®1
Treatment with Remsima® administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab.
- Administer IV infliximab at week 0 and 2, according to specific dose for each condition.
- Continue with SC infliximab (Remsima® ) from week 6, every 2 weeks.
When switching from infliximab IV maintenance therapy1
When switching from maintenance therapy of intravenous infliximab to the subcutaneous formulation of Remsima®, the subcutaneous formulation may be administered 8 weeks after the last administration of the intravenous infusions of infliximab, then, every 2 weeks.
-
Dosing for each indication1
Moderate to severe Crohn's disease1
Posology
* Available data do not support further infliximab treatment, in patients not responding within 6 weeks of the initial infusion.1
Refractory fistulising Crohn's disease1
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.
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 severe 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.Re-administration for ulcerative colitis
From experience with intravenous infliximab, the safety and efficacy of re-administration, after an interval of more than every 8 weeks, has not been established.
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.
Re-administration for ankylosing spondylitis
From experience with intravenous infliximab, the safety and efficacy of re-administration, after an interval of more than 6 to 8 weeks, has not been established.
Rheumatoid arthritis
Posology
Must be given concomitantly with methotrexate.
* Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment
Re-administration for rheumatoid arthritis1
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
May be administered in combination with methotrexate.
Re-administration for psoriatic arthritis
From experience with intravenous infliximab, the safety and efficacy of re-administration after an interval of more than 8 weeks, has not been established.
Moderate 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.
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.
-
Important dosing information1
MISSED
DOSEMissed dose for up to 7 days1If patients miss an injection of Remsima® subcutaneous formulation, they should be instructed to take the missed dose immediately if this happens within 7 days from the missed dose, and then remain on their original fortnightly dosing schedule.1
Missed dose for 8 days or more1If 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 fortnightly dosing schedule.1
RE-
ADMINISTRATIONRe-administration across indications1In case maintenance therapy is interrupted, 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.
-
Special populations1
-
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.
-
Safety and efficacy not established for children and adolescents under age 18. Therefore, subcutaneous use of Remsima® is recommended for use only in adults.
-
Authority required. Refer to PBS Schedule for full authority information.
Reference
1. Remsima® Australian Product Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-PI-02540-1&d=202103141016933&d=20221121172310101. Last accessed: Nov 2022.
Abbreviations
IV, intravenous; MTX, methotrexate; SC, subcutaneous;