It is important to know that molnupiravir (Tradename LAGEVRIO) may cause harm to your unborn baby. It is not known if LAGEVRIO will harm your baby if you take LAGEVRIO during pregnancy.

• LAGEVRIO is not recommended for use in pregnancy.

• Molnupiravir has not been studied in pregnancy. It was studied in pregnant animals only. When given to pregnant animals, molnupiravir caused harm to their unborn babies.

• You and your healthcare provider may decide that you should take LAGEVRIO during pregnancy if there are not other treatment options approved or authorized by the FDA that are accessible or clinically appropriate for you.

• If you and your healthcare provider decide that you should take LAGEVRIO during pregnancy, you and your healthcare provider should discuss the known and potential benefits and the potential risks of taking LAGEVRIO during pregnancy.

For Individuals who are able to become Pregnant

Individuals who are able to become pregnant should use a reliable method of birth control (contraception) consistently and correctly during treatment with LAGEVRIO and for 4 days after the last dose of LAGEVRIO. Talk to your healthcare provider about reliable birth control methods.

Before starting treatment with LAGEVRIO your healthcare provider may do a pregnancy test to see if you are pregnant before starting treatment with LAGEVRIO.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LAGEVRIO.

COVID-PR is a pregnancy registry for individuals who take LAGEVRIO during pregnancy. The purpose of this program is to collect information about the health of you and your baby.

If you are pregnant or become pregnant during treatment with LAGEVRIO, you are encouraged to report your use of LAGEVRIO during pregnancy to this pregnancy registry at https://covid-pr.pregistry.com or 1-800-616-3791.

Overview and Background

In the US, molnupiravir (LAGEVRIO) is an investigational medicine that the FDA authorized (under an Emergency Use Authorization) for use for the treatment of adults with a current diagnosis of mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, and for whom other COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

LAGEVRIO is not authorized for use:

• In patients less than 18 years of age,

• For the prevention of COVID-19,

• For people needing to be hospitalized for COVID-19.

LAGEVRIO is taken by mouth (with or without food) as 4 capsules every 12 hours for 5 days. LAGEVRIO is not authorized for use for longer than 5 days.

Appropriate Patients for LAGEVRIO

LAGEVRIO is for adults who have mild or moderate COVID-19 and are at high risk for progressing to severe COVID-19, including hospitalization and death. In addition, to being high risk, these adults cannot take other treatments approved or authorized by the FDA because these other treatments may not be accessible or not clinically appropriate.

Conditions that increase risk for developing severe disease in adults include older age, obesity, kidney or liver disease, certain heart and neurologic conditions, lung disorders, and an immunocompromised state. Consult the US Centers for Disease Control and Prevention for a comprehensive list of these conditions at

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html

Pregnancy and being recently pregnant is also a risk factor for progression of mild to moderate COVID-19 to severe disease. Furthermore, COVID-19 puts your fetus at risk for premature birth and fetal death. As mentioned in the beginning of this document, molnupiravir is not recommended in pregnancy as it caused harm to unborn babies in animal studies (see section below).

Pregnancy and Lactation Issues for Molnupiravir (LAGEVRIO)

Molnupiravir was not studied in pregnant people. Molnupiravir was studied in pregnant animals. In pregnant rats, it caused harm to their unborn baby. When given to pregnant rats, molnupiravir resulted in loss of early pregnancy and birth defects. Based on the results in the animal studies, molnupiravir may cause harm to the human unborn baby and is therefore not recommended for use in pregnancy. This pregnancy registry is designed to collect information from people who became pregnant or used molnupiravir while pregnant.

It is not known if LAGEVRIO is present in human milk. It is also not known if LAGEVRIO may harm the breastfeeding infant. Breastfeeding is not recommended while taking LAGEVRIO and for 4 days after taking the last dose.

References

Centers for Disease Control and Prevention. People with Certain Medical Conditions. Accessed May 11, 2023.

Centers for Disease Control and Prevention. Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals. Accessed May 11, 2023.

National Institutes of Health. Coronavirus disease 2019 (COVID-19) treatment guidelines. Accessed May 11, 2023.

National Institutes of Health. COVID-19 Treatment Guidelines for Molnupiravir Updated: April 20, 2023. Accessed May 11, 2023.

US Food and Drug Administration. Fact sheet for healthcare providers: Emergency use authorization for Molnupiravir. Accessed August 13, 2023.

US Food and Drug Administration. Fact Sheet for Patients And Caregivers: Emergency Use Authorization (EUA) Of LAGEVRIO™ (molnupiravir) capsules For Coronavirus Disease 2019. Accessed May 11, 2023.