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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 (IV formulation) US FDA pregnancy category: Not assigned. (subcutaneous formulation) Risk Summary: This drug crosses the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. Another TNF-blocking monoclonal antibody administered during pregnancy was detected for up to 6 months in the serum of infants. When administered subcutaneously in animal studies during the period of organogenesis at doses 360 times the maximum recommended human dose (MRHD), no adverse fetal effects were noted. Comments: -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 last dose.

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. 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

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Simponi (golimumab)." Centocor Inc, Malvern, PA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Simponi (golimumab)." Centocor Inc, Malvern, PA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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