reased risk of infection [see Drug Interactions (7.3)].
5.13 Switching between Biological Disease-Modifying Antirheumatic Drugs(DMARDs)Care should be taken when switching from one biologic to another, since overlapping
biological activity may further increase the risk of infection.
5.14 Autoimmunity
Treatment with infliximab products may result in the formation of autoantibodies and in thedevelopment of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupuslikesyndrome following treatment with RENFLEXIS, treatment should be discontinued [seeAdverse Reactions (6.1)].
5.15 Live Vaccines/Therapeutic Infectious Agents In patients receiving anti-TNF therapy, limited data are available on the response tovaccination with live vaccines or on the secondary transmission of infection by live vaccines.
Use of live vaccines can result in clinical infections, including disseminated infections. Theconcurrent administration of live vaccines with RENFLEXIS is not recommended.
Fatal outcome due to disseminated BCG infection has been reported in an infant whoreceived a BCG vaccine after in utero exposure to infliximab products. Infliximab productsare known to cross the placenta and have been detected up to 6 months following birth. Atleast a six month waiting period following birth is recommended before the administration ofany live vaccine to infants exposed in utero to infliximab products.
Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladderinstillation for the treatment of cancer) could result in clinical infections, includingdisseminated infections. It is recommended that therapeutic infectious agents not be givenconcurrently with RENFLEXIS.
It is recommended that all pediatric patients be brought up to date with all vaccinations priorto initiating RENFLEXIS therapy. The interval between vaccination and initiation ofRENFLEXIS therapy should be in accordance with current vaccination guidelines.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a drug cannot be directly compared to rates in the clinicaltrials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Adults
The data described herein reflect exposure to infliximab in 4779 adult patients (1304 patientswith rheumatoid arthritis, 1106 patients with Crohn’s disease, 202 with ankylosingspondylitis, 293 with psoriatic arthritis, 484 with ulcerative colitis, 1373 with plaque psoriasis,and 17 patients with other conditions), including 2625 patients exposed beyond 30 weeks and374 exposed beyond 1 year. [For information on adverse reactions in pediatric patients seeAdverse Reactions (6.1).] One of the most-common reasons for discontinuation of treatmentwas infusion-related reactions (e.g., dyspnea, flushing, headache and rash).
Infusion-related Reactions
An infusion reaction was defined in clinical trials as any adverse event occurring during aninfusion or within 1 hour after an infusion. In Phase 3 clinical studies, 18% of infliximabtreatedpatients experienced an infusion reaction compared to 5% of placebo-treated patients.
Of infliximab-treated patients who had an infusion reaction during the induction period, 27%experienced an infusion reaction during the maintenance period. Of patients who did not have |
