What are the important possible side effects of LAGEVRIO?
- See, “What is the most important information I should know about LAGEVRIO?” in the Fact Sheet for Patients & Caregivers.
- Allergic Reactions. 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
- Skin rash
The most common side effects of LAGEVRIO are:
- Diarrhea
- Nausea
- Dizziness
These are not all the possible side effects of LAGEVRIO. Not many people have taken 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.
What if I am pregnant?
- 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.
- LAGEVRIO has not been studied in pregnancy. LAGEVRIO was studied in pregnant animals only. When LAGEVRIO was given to pregnant animals, LAGEVRIO caused harm to their unborn babies.
- 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.
For individuals who are able to become pregnant:
- You 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.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LAGEVRIO.
Pregnancy Registry:
- 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.
For individuals who are sexually active with partners who are able to become pregnant:
- It is not known if LAGEVRIO can affect sperm. While the risk is regarded as low, animal studies to fully assess the potential for LAGEVRIO to affect the babies of males treated with LAGEVRIO have not been completed. A reliable method of birth control (contraception) should be used consistently and correctly during treatment with LAGEVRIO and for at least 3 months after the last dose. The risk to sperm beyond 3 months is not known. Studies to understand the risk to sperm beyond 3 months are ongoing. Talk to your healthcare provider about reliable birth control methods. Talk to your healthcare provider if you have questions or concerns about how LAGEVRIO may affect sperm.
- The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make LAGEVRIO available during the COVID-19 pandemic for the treatment of COVID-19. (For more details about an EUA, please see the “What is an Emergency Use Authorization (EUA)?” section in the Fact Sheet for Patients & Caregivers.) LAGEVRIO is not an FDA-approved medicine in the United States. Read the Fact Sheet for Patients & Caregivers for information about LAGEVRIO. Talk to your healthcare provider about your options if you have any questions. It is your choice to take LAGEVRIO.
COVID-19, coronavirus disease 2019.