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Is it safe? · Pregnancy Smart

Infliximab (Remicade) During Pregnancy

Assigned clinical reviewerMatt Stahl· PharmDDraft · pending clinical reviewUpdated

What does the evidence say about infliximab during pregnancy?

  1. MotherToBaby summarizes studies of hundreds of infliximab or TNF-inhibitor exposures without a clear increase in miscarriage, major birth differences, preterm birth, poor fetal growth, or newborn complications. It notes that underlying illness can confound these outcomes. 1
  2. The current Remicade label states that infliximab crosses the placenta during the third trimester and has been detected in infant serum for up to six months. It directs that live vaccines not be given to exposed infants for six months after birth. 2
  3. In a U.S. inflammatory bowel disease registry cited in the Remicade label, 294 infliximab-exposed pregnancies were compared with 515 pregnancies not exposed to biologics. The registry did not identify higher major birth-difference, pregnancy-loss, low-birth-weight, small-for-gestational-age, or infant-infection rates. 2
  4. A manufacturer postmarketing analysis described 1,850 prospectively reported infliximab pregnancies with known outcomes, including 1,526 live births. Reported congenital-anomaly and preterm-birth proportions showed no unexpected pattern, but missing outcomes, absent comparator analyses, and sponsor involvement limit inference. 3
  5. The prospective PIANO cohort followed 1,490 pregnancies in people with inflammatory bowel disease, including 869 biologic exposures and 421 infliximab exposures. Drug classes were not associated with higher major birth-difference, pregnancy-loss, preterm-birth, low-birth-weight, or infant-infection risk, while active disease was associated with worse outcomes. 4

Is infliximab safe in each trimester?

  • First trimester. MotherToBaby reports little expected placental transfer in the first trimester, and observational studies have not identified a clear miscarriage or major birth-difference increase. Review disease control and all companion medicines with the prescribing and prenatal specialists.
  • Second trimester. Placental transfer begins to increase in the second trimester. Timing decisions should balance fetal exposure with the maternal and pregnancy risks of active inflammatory disease; there is no universal stop week that applies to every condition or patient.
  • Third trimester. Infliximab crosses the placenta efficiently late in pregnancy and can remain in infant serum after birth. Tell the pediatric team the last infusion date so the current six-month live-vaccine restriction in the U.S. label is followed.

Frequently asked questions

Can you stay on Remicade during pregnancy?

Some patients continue infliximab with gastroenterology, rheumatology, and obstetric oversight because active inflammatory disease also carries pregnancy risks. The decision depends on condition, prior flares, infusion timing, companion medicines, and response. Do not change an infusion schedule without the prescriber.

When should infliximab be stopped before the third trimester?

There is no universal stop week. Placental transfer increases in the second and third trimesters, but stopping too early can permit disease activity. The specialist plan should weigh late fetal exposure against the individual's flare history and the consequences of uncontrolled illness.

Does infliximab cross the placenta?

Yes. MotherToBaby describes little expected transfer in the first trimester and increasing transfer later. In the PIANO concentration subset, infant or cord infliximab levels were often higher than maternal levels, but those blood levels alone do not establish birth-outcome safety.

Does infliximab increase the chance of birth defects?

Large observational datasets have not identified a clear increase in major birth differences. These are not randomized comparisons, and disease severity, other medicines, incomplete reporting, and wide confidence intervals limit certainty. They support counseling but do not prove zero risk.

Why do babies exposed to infliximab need to delay live vaccines?

Infliximab can remain in infant serum after late-pregnancy exposure. The current U.S. Remicade label directs no live vaccines for six months after birth. Tell the pediatric clinician about pregnancy exposure and the last infusion before vaccines are scheduled.

Which infant vaccines are affected after infliximab exposure?

The restriction applies to live vaccines. MotherToBaby notes that rotavirus is the routinely offered live vaccine in the first year in the United States. The pediatric team should apply the current schedule and exposure timing; nonlive vaccines are not covered by this label restriction.

Does infliximab exposure increase infant infections?

The PIANO cohort did not find biologic exposure associated with higher infant infection rates during the first year, and measured infant drug concentration was not linked to infections. Follow-up and disease-confounding limits remain, so this does not cancel the live-vaccine restriction.

Can infliximab be used while breastfeeding?

MotherToBaby reports that infliximab is a large protein found in breast milk in small amounts and is expected to be poorly absorbed from the infant gut. Published reports have not identified clear negative infant effects, but feeding plans still belong in the specialist discussion.

What information should the baby's clinician receive?

Provide the exact medicine, the last pregnancy infusion date, whether other immune-modifying medicines were used, gestational age at the final dose, and the current Remicade label's six-month live-vaccine restriction. This lets the pediatric team plan vaccines from the actual exposure.

Related in the library

References

  1. Infliximab

    MotherToBaby via NCBI Bookshelf · https://www.ncbi.nlm.nih.gov/books/NBK582763/?report=printable

  2. REMICADE (infliximab) prescribing information

    U.S. Food and Drug Administration · https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/103772s5412lbl.pdf

  3. Exposure to Infliximab During Pregnancy: Post-Marketing Experience

    PubMed Central · https://pmc.ncbi.nlm.nih.gov/articles/PMC7007430/

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.