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Remdesivir Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on May 12, 2022.

Remdesivir is also known as: Veklury

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:
-A pregnancy exposure registry is available.
-According to some authorities: Patients of childbearing potential should use effective contraception during therapy.
-There are maternal and fetal risks associated with untreated coronavirus disease 2019 (COVID-19) in pregnancy.

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.

To monitor the pregnancy outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Pregnant and recently pregnant patients can enroll at covid-pr.pregistry.com or call 1-800-616-3791 for information about the registry.

COVID-19 in pregnancy is associated with adverse maternal and fetal outcomes (including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death).

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.

Excreted into human milk: Yes (very low [parent drug and its active metabolite])

Comments:
-Limited data available on the use of this drug during breastfeeding; information from 1 patient indicates that milk levels of this drug and its active metabolite are very low.
-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 poorly absorbed orally, and the metabolite is only partially 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 and for coronavirus disease 2019 (COVID-19) with no serious adverse drug reactions.

The most common side effects reported after IV infusion included elevated aminotransferase levels, elevated bilirubin levels, other liver enzyme elevations, diarrhea, rash, renal dysfunction, and hypotension.

A woman was diagnosed with a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection 2 days after delivery; she was given 200 mg of this drug on the first day of therapy, then 100 mg once a day for 4 more days (route not provided; presumed IV). Milk was collected on the fifth day of therapy, just before the dose and 1, 3, 6, and 24 hours after the last dose; the parent drug and its metabolite (GS-441524) were measured in milk. Parent drug milk level was 1.29 mcg/L an hour before administration on day 5, but undetectable (less than 0.5 mcg/L) in the other samples; GS-441524 milk levels were 13.5 mcg/L before the fifth dose, 285 mcg/L at 3 hours after the dose, and 64.3 mcg/L at 24 hours after the dose. According to author estimation, the relative infant doses of the parent drug and GS-441524 in breast milk were 0.007% and 1.6%, respectively. The half-life of GS-441524 in milk was 9.3 hours (estimated).

See references

References for pregnancy information

  1. "Product Information. Veklury (remdesivir)." Gilead Sciences Pty Ltd (2022):
  2. "Product Information. Veklury (remdesivir)." Gilead Sciences (2022):

References for breastfeeding information

  1. "Product Information. Veklury (remdesivir)." Gilead Sciences (2022):
  2. National Library of Medicine (US), National Center for Biotechnology Information "Remdesivir - Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK556881/"

Further information

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