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​​​​​L​agevrio (mo​lnupiravir)

Important Information About Lagevrio

Lagevrio (molnupiravir, MK-4482) is authorized for the treatment of mild to moderate COVID-19 in adults age 18 years and older, who are at high risk for progressing to severe COVID-19 and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. Lagevrio is an oral antiviral drug that is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

Emergency Use Authorization of Lagevrio

The Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS)​ will oversee the fair and equitable allocation of Lagevrio to state and territorial health departments and, select Health Resources and Services Administration (HRSA)-funded health centers.

HHS has purchased about 3 million courses of Lagevrio. An initial 300,000 courses of Lagevrio was shipped to states and territories arrived at dispensing sites by the end of December. Initial allocations of Lagevrio were determined on a pro rata basis and is provided to state and territorial health departments for free.

State and territorial health departments will allocate product to dispensing sites across their jurisdictions, and the distributor will ship product directly to sites, which include pharmacies, doctors’ offices, clinics, hospitals, urgent care centers, and local health departments.

Equity remains a top priority in the nation’s COVID-19 response. As part of our commitment to equitable access, HHS will identify a subset of 200 Health Resources and Services Administration (HRSA)-funded health centers across all 50 states to receive a direct allotment of Lagevrio each distribution cycle. This allotment will equal about 15% of the total product available to HHS in a given distribution period, and allocation of product to these centers will be separate from the pool of product allocated to states and territories. Health departments will have insight into selected HRSA-funded health centers and their product allocations and reporting. This effort will complement the focus health departments are already placing on equity by helping ensure Lagevrio is accessible to some of the most vulnerable communities and hard-hit populations around the country.

Lagevrio FDA EUA Resources

Lagevrio

 

Lagevrio (molnupiravir)

Hello, I’m Dr. Colin Shepard. I serve as the CDC Liaison to the HHS Assistant Secretary for Preparedness and Response, also called ASPR. I want to talk about one of the therapeutics that can help people with COVID-19—Lagevrio, also known as molnupiravir.

What is Lagevrio?

Lagevrio is an oral antiviral used to help fight the coronavirus infection by stopping the coronavirus from replicating in the body. This lowers the viral load, reducing the chances of the illness progressing to more serious symptoms and hospitalization.

Who is eligible for Lagevrio?

Lagevrio is for adults who are at high risk for developing serious symptoms of COVID-19 that may lead to hospitalization or death. For more information about who is at high risk, please see the resources provided in the description. Lagevrio is for people who have a positive COVID-19 rapid or PCR test with mild to moderate symptoms and who are not in the hospital. It should be administered as early as possible but needs to be given within 5 days of symptom onset.

How is Lagevrio administered?

Lagevrio requires a prescription. It is available through a pharmacy or health care clinic, including Test to Treat locations where these antivirals are being distributed for use at home. Patients will take pills twice a day for 5 days.

What are the limitations of use for Lagevrio?

Lagevrio is not for everyone. The medication is not for anyone under the age of 18 or pregnant women. It is not appropriate to start Lagevrio if you are already hospitalized for COVID-19. There are no known drug interactions with Lagevrio.

Lagevrio is one of several COVID-19 therapeutic options. Watch the other Outpatient COVID-19 Therapeutics Videos in this series for more information. Visit us online at https://aspr.hhs.gov/COVID-19 and please see the resources linked in the description to learn more. You can connect with ASPR on social media platforms to stay up to date on our latest posts and information that we share. Please email any questions to COVID19therapeutics@hhs.gov.

Thank you for your time.

Watch this video, featuring Colin Shepard, MD, CDC liaison to ASPR, as he discusses Lagevrio (molnupiravir), an oral antiviral authorized for the treatment of mild to moderate COVID‑19 for certain adults whom alternative COVID‑19 treatment options are not clinically appropriate

​Lagevrio Frequently Asked Questions

Oral antivirals are used to treat chronic or severe viral infections that cannot be eliminated by an individual’s natural immune response. Antivirals can function in a variety of ways to treat a virus, depending on the therapy and virus type.

Lagevrio is authorized for the treatment of mild to moderate COVID-19 in adults age 18 years and older, who are at high risk for progressing to severe COVID-19 and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. Pregnant individuals or women who may become pregnant should speak with a healthcare provider regarding any treatment limitations.

Yes; a prescription from a qualified healthcare provider is required to be treated with Lagevrio.

Initial allocations were determined on a pro rata basis (based on adult population) and will be provided to state and territorial health departments for free.

A subset of HHS Health Resources Services Administration (HRSA)-funded health centers across all 50 states will also receive direct product allocation to help increase equitable access to this product in vulnerable and hard-hit communities.

Yes. State and territorial health departments can order product through the HHS Health Partners Ordering Portal. Dispensing sites began receiving product in December 2021.

A Test to Treat locator is available to help find participating sites. A call center is also available at 1-800-232-0233 (TTY 1-888-720-7489) to get help in English, Spanish, and more than 150 other languages – 8:00 am to midnight ET, 7 days a week. The Disability Information and Access Line (DIAL) is also available to specifically help people with disabilities access services. To get help, call 1-888-677-1199, Monday-Friday from 9:00 am to 8:00 pm ET or email DIAL@usaginganddisability.org.

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