LAGEVRIO may cause serious side effects, including:<\/strong><\/p>\n\n\n\n\n For individuals who are able to become pregnant:<\/strong><\/p>\n\n\n\n Pregnancy Registry:<\/strong><\/p>\n\n\n\n For individuals who are sexually active with partners who are able to become pregnant:<\/strong><\/p>\n\n\n\n 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 \u201cWhat is an Emergency Use Authorization (EUA)?\u201d<\/strong> section in the Fact Sheet for Patients & Caregivers<\/a>.) LAGEVRIO is not an FDA-approved medicine in the United States. Read the Fact Sheet for Patients & Caregivers<\/a> for information about LAGEVRIO. Talk to your healthcare provider about your options if you have any questions. It is your choice to take LAGEVRIO.<\/p><\/div><\/div>\n<\/div><\/details><\/div>\n\n\n\n <\/p>\n<\/div><\/details><\/div>\n\n\n\n The United States FDA has made LAGEVRIO available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify emergency use of drugs and biological products during the COVID-19<\/span> pandemic. LAGEVRIO for the treatment of mild-to-moderate COVID-19<\/span> in adults with positive results of direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19<\/span>, including hospitalization or death, and for whom alternative COVID-19<\/span> treatment options approved or authorized by FDA are not accessible or clinically appropriate, has not undergone the same type of review as an FDA-approved product. In issuing an EUA under the COVID-19<\/span> public health emergency, the FDA has determined, among other things, that based on the total amount of scientific evidence available including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19<\/span>, or a serious or life-threatening disease or condition caused by COVID-19<\/span>; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved, and available alternatives. <\/p>\n\n\n\n All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19<\/span> pandemic. The EUA for LAGEVRIO is in effect for the duration of the COVID-19<\/span> declaration justifying emergency use of LAGEVRIO, unless terminated or revoked (after which LAGEVRIO may no longer be used under the EUA).<\/p>\n<\/div><\/details><\/div>\n\n\n\n LAGEVRIO is an investigational medicine used to treat mild-to-moderate COVID-19<\/span> in adults:<\/p>\n\n\n\n The FDA has authorized the emergency use of LAGEVRIO for the treatment of mild-to-moderate COVID-19 in adults under an EUA. For more information on EUA, see the \u201cWhat is an Emergency Use Authorization (EUA)?\u201d<\/strong> section in the Fact Sheet for Patients & Caregivers<\/a>.<\/p><\/div><\/div>\n\n\n\n LAGEVRIO is not authorized:<\/p>\n\n\n\n No, it is not a vaccine. LAGEVRIO is an investigational medicine used to treat mild-to-moderate COVID-19<\/span> in certain adults.<\/p>\n<\/div><\/details><\/div>\n\n\n\n Yes, LAGEVRIO is a prescription medication.<\/p>\n<\/div><\/details><\/div>\n\n\n\n Tell your healthcare provider if you:<\/p>\n\n\n\n Yes. Eligible, privately insured patients may pay as little as $10 per prescription, up to a maximum program savings of $300 per patient. Coupon may be redeemed before the expiration date printed on the coupon, on each qualifying prescription up to a 5-day supply. Click here to view the savings offer<\/a>.<\/p><\/div><\/div>\n\n\n\n Patients must have private insurance with coverage for LAGEVRIO in order to be eligible for the coupon.<\/p>\n\n\n\n Not valid for patients who are uninsured or patients with Medicare or other Government Program insurance. Not all patients are eligible. Certain restrictions apply. Please see Terms and Conditions<\/a>.<\/p><\/div><\/div>\n<\/div><\/details><\/div>\n\n\n\n LAGEVRIO may cause harm to your unborn baby. It is not known if LAGEVRIO will harm your baby if you take LAGEVRIO during pregnancy.<\/strong><\/p>\n\n\n\n For individuals who are able to become pregnant:<\/strong><\/p>\n\n\n\n Pregnancy Registry:<\/strong><\/p>\n\n\n\n For individuals who are sexually active with partners who are able to become pregnant:<\/strong><\/p>\n\n\n\nHas LAGEVRIO been approved by the FDA?<\/strong><\/h3><\/summary>
What is an Emergency Use Authorization (EUA)?<\/strong><\/h3><\/summary>
What is LAGEVRIO?<\/strong><\/h3><\/summary>
Is LAGEVRIO the same as a COVID-19<\/span> vaccine?<\/strong><\/h3><\/summary>
Do I need a prescription to get LAGEVRIO?<\/strong><\/h3><\/summary>
What should I tell my healthcare provider before I take LAGEVRIO?<\/strong><\/h3><\/summary>
Is there a coupon offer available for LAGEVRIO?<\/strong><\/h3><\/summary>
What if I am pregnant?<\/strong><\/h3><\/summary>