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Remdesivir Pregnancy and Breastfeeding Warnings

Remdesivir is also known as: Veklury

Medically reviewed by Drugs.com. Last updated on Nov 20, 2020.

Remdesivir Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-According to some authorities: Patients of childbearing potential must use effective contraception during therapy.
-Pregnant patients hospitalized with coronavirus disease 2019 (COVID-19) are at risk for serious morbidity and mortality.

Animal studies have failed to reveal evidence of embryofetal toxicity. In rats and rabbits, this drug showed no adverse effect on embryofetal development when administered to pregnant animals at systemic exposures (AUC) of the main circulating metabolite of this drug (GS-441524) that were up to 4 times the exposure in humans at the recommended human dose. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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

Remdesivir Breastfeeding Warnings

LactMed: Based on limited data, it does not appear that mothers using this drug need to avoid breastfeeding; however, until more data are available, this drug should be used with careful infant monitoring during breastfeeding.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-According to some authorities: Breastfeeding patients with coronavirus disease 2019 (COVID-19) should follow practices according to clinical guidelines to avoid exposing infants to COVID-19.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

This drug is administered IV as it is poorly absorbed orally; infants are not likely to absorb clinically significant amounts of the drug from milk. In addition, neonates have received this drug IV for Ebola with no serious adverse drug reactions.

The most common side effects reported after IV infusion included elevated aminotransferase and bilirubin levels and other liver function tests; diarrhea, rash, renal dysfunction, and hypotension have also been reported.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Veklury (remdesivir)." Gilead Sciences, Foster City, CA.

References for breastfeeding information

  1. "Product Information. Veklury (remdesivir)." Gilead Sciences, Foster City, CA.
  2. National Library of Medicine (US) "Drugs and Lactation Database (LactMed) Available from: URL: https://www.ncbi.nlm.nih.gov/books/NBK501922/" (2006):
  3. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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