Remdesivir

THE SAFETY OF REMDESIVIR DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION IS UNLIKELY TO CAUSE HARM TO YOUR BABY:

Remdesivir is an investigational antiviral medication used for treatment of severe COVID-19 positive illness. There is currently limited information available on the safety of remdesivir in pregnant women and women who are breastfeeding infants. Animal studies and case reports in pregnant women with Ebola found no evidence of adverse maternal or neonatal effects with remdesivir. However, it is recommended that you weigh the potential risks versus benefits before using this medication during pregnancy or while breastfeeding.

What is remdesivir?

Remdesivir is an investigational antiviral medication that has been given emergency approval for treatment of severe coronavirus disease 2019 (COVID-19). Remdesivir is given intravenously in hospitalized patients via infusion with a loading dose of 200 mg on day one, then 100 mg once daily thereafter in adults and children over 40 kg in weight. Treatment duration is 5 days in patients not on mechanical ventilation or extracorporeal membrane oxygenation, but can be extended up to 10 days in patients who fail to have clinical improvement at 5 days or patients who require mechanical ventilation or extracorporeal membrane oxygenation. Children less than 40 kg in weight require weight-based dosing of remdesivir. Remdesivir is available as a generic medication and is not commercially available. Expanded access is available through the FDA for nonpregnant, adult patients. Compassionate use is allowed for pregnant women and patients under 18 years of age with severe COVID-19. 

What is remdesivir used to treat?

Remdesivir has been granted emergency use authorization by the FDA to treat suspected or confirmed COVID-19 in adults and children with severe disease. The virus that causes this disease is known as the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is related to the SARS and Middle East Respiratory Syndrome (MERS) viruses reported in the 2000’s. SARS-CoV-2 spreads from person-to-person via close contact and respiratory droplets; however, contaminated surfaces may also be a vector for virus transmission. Symptoms of the virus appear 2-14 days after virus exposure, and it can produce a wide range of symptoms. Older patients and patients with comorbidities (other illnesses that make the reaction to the virus worse) are at a higher risk of complications. Social distancing, wearing cloth masks, frequently washing hands, and disinfecting contaminated surfaces are expected to reduce the spread of the virus. Pregnant women who are treated for COVID-19 with remdesivir are encouraged to enroll in the International Registry of Coronavirus Exposure in Pregnancy (IRCEP): https://corona.pregistry.com. The U.S. Centers for Disease Control and Prevention provide interim guidance on treating pregnant women with COVID-19.

You can find out more about the use of remdesivir in pregnant, COVID-19 positive patients here.

How does remdesivir work?

Remdesivir works by being broken down by the body into a form that is incorporated into viral RNA, and subsequently interferes with COVID-19 viral replication. 

If I am taking remdesivir, can it harm my baby?

There is limited information available on the safety of remdesivir in pregnant women. It is unknown if remdesivir crosses the human placenta to reach the developing baby. Remdesivir should only be given during pregnancy if the potential benefits outweigh the potential risks. 

Evidence from animal studies with remdesivir:

Pregnant rats and rabbits given intravenous remdesvir at doses up to 20 mg/kg/day during gestation had no adverse effects. 

Evidence for the risks of remdesivir in human babies:

A case report of remdesivir use in a critically ill, COVID-19 positive pregnant woman at 22 weeks gestation noted a nine day course of medication use, and only mild, transient elevations in liver enzymes. The patient was successfully discharged after 14 days of hospitalization and treatment with mechanical ventilation, remdesivir, convalescent plasma, and hydroxychloroquine. In trials of remdesivir use to treat Ebola, pregnant women and infants exposed to the medication had no reports of adverse events.

Bottom line: There is currently limited information available on the safety of remdesivir in pregnant women. Remdesivir should only be given during pregnancy if the potential benefits outweigh the potential risks.

If I am taking remdesivir and become pregnant, what should I do?

If you are taking remdesivir and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.

If I am taking remdesivir, can I safely breastfeed my baby?

Remdesivir is administered intravenously so it is not expected to be significantly absorbed by nursing infants. Animal studies suggest remdesivir exposure in nursing infants may be up to 1% of the mother’s dose of the medication. Nursing infants with exposure to Ebola have been administered redemesir without adverse events reported. There is limited information available on the impact of remdesivir on milk production. Current limited information suggests remdesivir is probably safe while breastfeeding; however, if remdesivir is used while breastfeeding, close infant monitoring is recommended. Potential adverse events associated with remdesivir could include elevated bilirubin or liver enzymes, diarrhea, rash, low blood pressure, or impairment in kidney function.The potential risks and benefits of remdesivir use while breastfeeding should be weighed before use. It is important to consider the potential for viral transmission of COVID-19 from mother to nursing infant as well as potential adverse effects of remdesivir use. The U.S. Centers for Disease Control and Prevention provide interim guidance on breastfeeding and nursing infants for women who are COVID-19 positive. 

Bottom line: There is currently limited information available on the safety of remdesivir in women who are breastfeeding infants. It is important to weigh the risks versus benefits of remdesivir before using it while breastfeeding.

If I am taking remdesivir, will it be more difficult to get pregnant?

Studies in male rats receiving two times the maximum recommended human doses of remdesivir had no negative effects on fertility. Female rats receiving 1.3 times the maximum recommended human dose of remdesivir during conception or mating were more likely to experience reproductive toxicity as well as negative changes in embryo viability. 

If I am taking remdesivir, what should I know?

There is currently limited information available on the safety of remdesivir in pregnant women and women who are breastfeeding infants. Animal studies and case reports of remdesivir in pregnant women with Ebola found no evidence of negative effects in the mother or baby. However, it is recommended to weigh the potential risks versus benefits before using this medication.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of remdesivir during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about the individual medications used to treat infections here, and our report about COVID-19 (coronavirus) here.   Additional information can also be found in the resources below. 

For more information about remdesivir during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links.

Gile
ad: Remdesivir Prescribing Information/EUA

U.S. Centers for Disease Control: Coronavirus disease 2019 (COVID-19)

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General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.