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Authorized for emergency use in the treatment of COVID-19

  • LAGEVRIO™ (molnupiravir) has not been approved, but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA), for the treatment of adults with mild-to-moderate COVID-19, who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
  • The emergency use of LAGEVRIO is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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What is LAGEVRIO™ (molnupiravir)?

  • LAGEVRIO™ (molnupiravir) is an investigational medicine used to treat adults with mild-to-moderate COVID-19:
    • who are at risk for progression to severe COVID-19 including hospitalization or death, and for
    • whom other COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate

What is COVID-19?

COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through close contact with another person who has the virus.

COVID-19 illnesses have ranged from very mild-to-severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. Older people and people of all ages with severe, long lasting (chronic) medical conditions like heart disease, lung disease and diabetes, for example seem to be at higher risk of being hospitalized for COVID-19.

EUA, emergency use authorization; COVID-19, coronavirus disease 2019.

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Authorized Use

  • LAGEVRIO™ (molnupiravir) is an investigational medicine used to treat adults with mild-to-moderate COVID-19:
    • who are at risk for progression to severe COVID-19 including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
  • LAGEVRIO is not authorized:
    • For use in people less than 18 years of age
    • For prevention of COVID-19
    • For patients needing hospitalization for COVID-19
    • For use for longer than 5 consecutive days

Important Safety Information

  • 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 and has not been studied in pregnancy.
  • You and your healthcare provider may decide that you should take LAGEVRIO during pregnancy if there are no other COVID-19 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.
  • Individuals who are able to become pregnant should use a reliable method of birth control (contraception) correctly and consistently during treatment with LAGEVRIO and for 4 days after the last dose of LAGEVRIO. Talk to your healthcare provider about reliable birth control methods and tell your healthcare provider right away if you become pregnant or think you may have become pregnant during treatment with LAGEVRIO. Before starting treatment with LAGEVRIO your healthcare provider may do a pregnancy test to see if you are not pregnant.
  • There 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.
  • It is not known if LAGEVRIO can affect sperm, but the risk is regarded as low, based on animal studies. A reliable method of birth control (contraception) should be used correctly and consistently during treatment with LAGEVRIO and for at least 3 months after the last dose. The risk to sperm beyond 3 months is not known. Talk to your healthcare provider about reliable birth control methods or if you have questions or concerns about how LAGEVRIO may affect sperm.
  • Before taking LAGEVRIO, tell your healthcare provider about all of your medical conditions including if you have any allergies, serious illnesses, or are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Allergic reactions can happen in people taking LAGEVRIO even after only 1 dose. Stop taking LAGEVRIO and call your healthcare provider right away if you get any of the following symptoms of an allergic reaction: hives, rapid heartbeat, trouble swallowing or breathing, swelling of the mouth, lips, or face, throat tightness, hoarseness, or skin rash.
  • The most common side effects of LAGEVRIO are diarrhea, nausea, and dizziness. These are not all the possible side effects of LAGEVRIO. Serious and unexpected side effects may happen. This medicine is still being studied, so it is possible that all of the risks are not known at this time. Contact your healthcare provider if you have any side effects that bother you or do not go away.
  • Breastfeeding is not recommended during treatment with LAGEVRIO and for 4 days after the last dose of LAGEVRIO. If you are breastfeeding or plan to breastfeed, talk to your healthcare provider about your options and specific situation before taking LAGEVRIO.
  • Take LAGEVRIO exactly as your healthcare provider tells you to take it. Take LAGEVRIO for 5 days. It is important that you complete the full 5 days of treatment with LAGEVRIO. Do not stop taking LAGEVRIO before you complete the full 5 days of treatment, even if you feel better.
  • Contact your healthcare provider if you have any side effects that bother you or do not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088)

Please read the accompanying Fact Sheet for Patients and Caregivers for LAGEVRIO™ (molnupiravir) and discuss it with your doctor.
The Fact Sheet for Healthcare Providers also is available.

Authorized Use
Important Safety Information for LAGEVRIO (molnupiravir)

  • LAGEVRIO™ (molnupiravir) is an investigational medicine used to treat adults with mild-to-moderate COVID-19:
    • who are at risk for progression to severe COVID-19 including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
  • LAGEVRIO is not authorized:
    • For use in people less than 18 years of age
    • For prevention of COVID-19
    • For patients needing hospitalization for COVID-19
    • For use for longer than 5 consecutive days

Important Safety Information for LAGEVRIO (molnupiravir)

  • 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 and has not been studied in pregnancy.
  • You and your healthcare provider may decide that you should take LAGEVRIO during pregnancy if there are no other COVID-19 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.
  • Individuals who are able to become pregnant should use a reliable method of birth control (contraception) correctly and consistently during treatment with LAGEVRIO and for 4 days after the last dose of LAGEVRIO. Talk to your healthcare provider about reliable birth control methods and tell your healthcare provider right away if you become pregnant or think you may have become pregnant during treatment with LAGEVRIO. Before starting treatment with LAGEVRIO your healthcare provider may do a pregnancy test to see if you are not pregnant.
  • There 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.
  • It is not known if LAGEVRIO can affect sperm, but the risk is regarded as low, based on animal studies. A reliable method of birth control (contraception) should be used correctly and consistently during treatment with LAGEVRIO and for at least 3 months after the last dose. The risk to sperm beyond 3 months is not known. Talk to your healthcare provider about reliable birth control methods or if you have questions or concerns about how LAGEVRIO may affect sperm.
  • Before taking LAGEVRIO, tell your healthcare provider about all of your medical conditions including if you have any allergies, serious illnesses, or are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Allergic reactions can happen in people taking LAGEVRIO even after only 1 dose. Stop taking LAGEVRIO and call your healthcare provider right away if you get any of the following symptoms of an allergic reaction: hives, rapid heartbeat, trouble swallowing or breathing, swelling of the mouth, lips, or face, throat tightness, hoarseness, or skin rash.
  • The most common side effects of LAGEVRIO are diarrhea, nausea, and dizziness. These are not all the possible side effects of LAGEVRIO. Serious and unexpected side effects may happen. This medicine is still being studied, so it is possible that all of the risks are not known at this time. Contact your healthcare provider if you have any side effects that bother you or do not go away.
  • Breastfeeding is not recommended during treatment with LAGEVRIO and for 4 days after the last dose of LAGEVRIO. If you are breastfeeding or plan to breastfeed, talk to your healthcare provider about your options and specific situation before taking LAGEVRIO.
  • Take LAGEVRIO exactly as your healthcare provider tells you to take it. Take LAGEVRIO for 5 days. It is important that you complete the full 5 days of treatment with LAGEVRIO. Do not stop taking LAGEVRIO before you complete the full 5 days of treatment, even if you feel better.
  • Contact your healthcare provider if you have any side effects that bother you or do not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088)

Please read the accompanying Fact Sheet for Patients and Caregivers for LAGEVRIO™ (molnupiravir) and discuss it with your doctor.
The Fact Sheet for Healthcare Providers also is available.