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Infliximab Pregnancy and Breastfeeding Warnings

Infliximab is also known as: Remicade

Infliximab Pregnancy Warnings

-Animal studies have not been conducted with this drug because it does not cross react with TNF alpha in species other than humans and chimpanzees. -The approximately 450 human pregnancies exposed to this drug 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 alpha, if this drug is administered during pregnancy it could affect normal immune responses in the newborn. In a study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNF alpha, there was no indication of maternal toxicity, embryotoxicity, or teratogenicity. -It is not known whether this drug can affect reproductive capacity or can cause fetal harm when administered to a pregnant woman. The available clinical experience is too limited to exclude a risk during pregnancy. -This drug crosses the placenta and has been detected up to 6 months in the serum of infants born to women treated during pregnancy. These infants may be at increased risk for infection. Administration of live vaccines to infants exposed in utero is not recommended for 6 months following the mother's last infusion during pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is not recommended unless clearly needed. AU TGA pregnancy category: C US FDA pregnancy category: B Comments: -Women of childbearing potential should use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last treatment. As with other IgG antibodies, this drug crosses the placenta and has been detected up to 6 months in the serum of infants born to female patients treated with during pregnancy. These infants may be at increased risk of infection, and caution is advised in the administration of live vaccines to these infants.

Infliximab Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Because human immunoglobulins are excreted in milk, women should not breast feed for at least 6 months after treatment is discontinued.

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