ts during pregnancyhave not reported a clear association with infliximab products and adverse pregnancyoutcomes. Infliximab products cross the placenta and infants exposed in utero should not beadministered live vaccines for at least 6 months after birth [see Clinical Considerations]. In adevelopment study conducted in mice using an analogous antibody, no evidence of maternaltoxicity, embryotoxicity or teratogenicity was observed [see Data].
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Theestimated background risk of major birth defects and miscarriage for the indicatedpopulations is unknown. In the U.S. general population, the estimated background risk ofmajor birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%,respectively.
Clinical Considerations
Fetal/Neonatal adverse reactions Infliximab products cross the placenta, and have been detected in the serum of infants up to 6months following birth. Consequently, these infants may be at increased risk of infection,including disseminated infection which can become fatal. At least a six month waiting periodfollowing birth is recommended before the administration of live vaccines (e.g., BCG vaccineor other live vaccines, such as the rotavirus vaccine) to these infants [see Warnings and
Precautions (5.15)]. Cases of agranulocytosis in infants exposed in utero have also beenreported [see Adverse Reactions (6.2)].
Data
Animal Data
Because infliximab products do not cross-react with TNFα in species other than humans andchimpanzees, animal reproduction studies have not been conducted with infliximab products.
An embryofetal development study was conducted in pregnant mice using an analogousantibody that selectively inhibits the functional activity of mouse TNFα. This antibody,administered during the period of organogenesis on gestation day 6 and 12 at IV doses up to40 mg/kg produced no evidence of maternal toxicity, embryotoxicity, or teratogenicity. Dosesof 10 to 15 mg/kg in pharmacodynamic animal models with the anti-TNF analogous antibodyproduced maximal pharmacologic effectiveness.
8.2 Lactation
Risk Summary
Available information is insufficient to inform the amount of infliximab products present inhuman milk, and the effects on the breastfed infant. There are no data on the effects ofinfliximab products on milk production.
The developmental and health benefits of breastfeeding should be considered along with themother’s clinical need for an infliximab product and any potential adverse effects on thebreastfed infant from infliximab products or from the underlying maternal condition.
8.4 Pediatric Use
The safety and effectiveness of infliximab products have been established in pediatricpatients 6 to 17 years of age for induction and maintenance treatment of Crohn’s disease.
However, infliximab products have not been studied in children with Crohn’s disease orulcerative colitis <6 years of age.
Pediatric Crohn’s Disease
RENFLEXIS is indicated for reducing signs and symptoms and inducing and maintainingclinical remission in pediatric patients with moderately to severely active Crohn’s diseasewho have had an inadequate response to conventional therapy [see Boxed Warnings,Warnings and Precautions (5), Indications and Usage (1.2), Dosage and Administration (2.2),Clinical Studies (14.2) and Adverse Reactions (6. |
