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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.

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. 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.

See references

Golimumab Breastfeeding Warnings

No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.

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

See references

References for pregnancy information

  1. "Product Information. Simponi (golimumab)." Centocor Inc, Malvern, PA.

References for breastfeeding information

  1. "Product Information. Simponi (golimumab)." Centocor Inc, Malvern, PA.

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