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Golimumab Pregnancy and Breastfeeding Warnings

Golimumab is also known as: Simponi, Simponi Aria

Golimumab Pregnancy Warnings

Use is not recommended AU TGA pregnancy category: C US FDA pregnancy category: B Comments: Women of childbearing potential should use adequate contraception and continue its use for at least 6 months after the last treatment. 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.

Animal studies have revealed no evidence of harm to maternal animals or fetuses. In utero exposure to the drug produced no developmental defects to the fetus. There are no controlled data in human pregnancy. IgG antibodies cross the placenta. Consequently, infants born of treated women may be at an increased risk of infection. Administration of live vaccines to infants exposed to this antibody in utero is not recommended for 6 months after the mother's last dose during pregnancy.

Golimumab Breastfeeding Warnings

In monkey breast milk, the mean breast milk to plasma concentration ratio was 0.002:1.

Use is not recommended. Breastfeeding should be withheld for at least 6 months after the last treatment. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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