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Infliximab Pregnancy and Breastfeeding Warnings

Infliximab is also known as: Avsola, Inflectra, Ixifi, Remicade, Renflexis

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.

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.

Use is not recommended unless clearly needed.

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

Risk Summary: This drug is not associated with adverse pregnancy outcomes.

-This drug crosses the placenta and has been detected in the serum of infants up to 6 months following birth. These infants may be at increased risk of infection, including disseminated infection which can become fatal.
-At least a 6-month waiting period following birth is recommended before the administration of live vaccines (e.g., BCG vaccine or other live vaccines, such as the rotavirus vaccine) to infants exposed to this drug in utero.
-Cases of agranulocytosis in infants exposed to this drug in utero have been reported.
-Women of childbearing potential should use adequate contraception during therapy and for at least 6 months after.

See references

Infliximab Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

-Because human immunoglobulins are excreted in milk, women should not breast feed for at least 6 months after treatment is discontinued.

This drug is usually either not detectable in breastmilk or detectable at very low levels. Absorption by the infant is minimal. No adverse effects were noted in infants exposed in utero and breastfed during maternal therapy. Most experts consider this drug to be a low risk to the nursing infant.

See references

References for pregnancy information

  1. Product Information. Remicade (infliximab). Centocor Inc. 2001.
  2. Product Information. Inflectra (infliximab). Pfizer U.S. Pharmaceuticals Group. 2019.
  3. Product Information. Renflexis (infliximab). Merck & Co., Inc. 2019.

References for breastfeeding information

  1. Product Information. Remicade (infliximab). Centocor Inc. 2001.
  2. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.
  3. Product Information. Inflectra (infliximab). Pfizer U.S. Pharmaceuticals Group. 2019.
  4. Product Information. Renflexis (infliximab). Merck & Co., Inc. 2019.

Further information

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