Golimumab Pregnancy and Breastfeeding Warnings

Brand names: Simponi, Simponi Aria

Medically reviewed by Drugs.com. Last updated on Jun 6, 2023.

Golimumab Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk summary: There are no adequate and well-controlled trials in pregnant women. Monoclonal antibodies, such as golimumab, are transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant.

Comments:
-There are no adequate and well-controlled data in human pregnancy.
-Women of childbearing potential should use adequate contraception during therapy and for at least 6 months after the last dose.
-This drug crosses the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant.
-TNF-blocking monoclonal antibodies administered during pregnancy have been detected for up to 6 months in the serum of infants.
-If this drug is administered during pregnancy, it could affect normal immune response in the newborn due to its inhibition of TNF.
-Women of childbearing potential should use adequate contraception during therapy and for at least 6 months after the last dose.
-Administration of live vaccines to infants exposed to this drug in utero is not recommended for 6 months following the mother's last dose.

Animal studies have failed to reveal evidence of fetal malformations or embryotoxicity. There is no evidence of maternal toxicity. Umbilical cord blood samples collected at the end of the second trimester have demonstrated that fetuses were exposed to golimumab during gestation. This drug was present in fetal serum at the end of the second trimester and in neonatal serum from birth to 6 months postpartum.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

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 dose.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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