Remsima Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Remsima treatment.
Pregnancy: The moderate number (approximately 450) of prospectively collected pregnancies exposed to infliximab with known outcomes, including a limited number (approximately 230) exposed during the first trimester, does not indicate unexpected effects on pregnancy outcome. Due to its inhibition of TNF_α, infliximab administered during pregnancy could affect normal immune responses in the newborn. In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNF_α, there was no indication of maternal toxicity, embryotoxicity or teratogenicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
The available clinical experience is too limited to exclude a risk, and administration of infliximab is therefore not recommended during pregnancy.
Infliximab crosses the placenta and has been detected up to 6 months in the serum of infants born to women treated with infliximab during pregnancy. Consequently, these infants may be at increased risk for infection. Administration of live vaccines to infants exposed to infliximab in utero is not recommended for 6 months following the mother's last infliximab infusion during pregnancy (see Precautions and Interactions).
Breast-feeding: It is unknown whether infliximab is excreted in human milk or absorbed systemically after ingestion. Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Remsima treatment.
Fertility: There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see Pharmacology: Toxicology: Preclinical safety data under Actions).