Information for Healthcare Professionals: remicade (infliximab) for intravenous (iv) injection: warnings and adverse reactions – labeling changes
WARNINGS
Hypersensitivity
- In rheumatoid arthritis, Crohn’s disease and psoriasis clinical trials, re-administration of Remicade after a period of no treatment resulted in a higher incidence of infusion reactions relative to regular maintenance treatment. In general, the benefitrisk of re-administration of Remicade after a period of no-treatment, especially as a reinduction regimen given at weeks 0, 2 and 6, should be carefully considered. In the case where Remicade maintenance therapy for psoriasis is interrupted, Remicade should be reinitiated as a single dose followed by maintenance therapy.
