Lagevrio (molnupiravir)

Important Lagevrio Updates

October 21, 2022: Shelf-Life Extension for All Lots of Lagevrio (molnupiravir)

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

Transcript

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

Download Lagevrio Information Sheet 372KB PDF

What is Lagevrio?

Lagevrio (molnupiravir) is an oral antiviral authorized for treatment of mild-moderate COVID-19 illness.

Patients take 4 capsules twice a day for 5 days. Lagevrio should be administered as early as possible following the diagnosis of COVID-19 and needs to be initiated within 5 days of symptom onset.

What is an oral antiviral?

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.

Who is eligible for Lagevrio?

Lagevrio is for adults 18 years and older who are at high risk for developing serious COVID-19 disease including hospitalization and/or death. Lagevrio should be considered for non-hospitalized patients who meet all of the following criteria:

Test positive for SARS-CoV-2 (with PCR or antigen test, including at-home tests)
Have symptoms consistent with mild-to-moderate COVID-19
Have one or more risk factors for severe COVID
Alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

Please see the FDA Fact Sheet for Healthcare Providers for additional information on Lagevrio eligibility criteria and risks associated with use.

Who is considered to have a risk factor for severe COVID-19?

Per the current CDC’s Interim Clinical Considerations for COVID-19 Treatment in Outpatient guidelines, risk factors include:

Age over 50 years, with risk increasing substantially at age ≥ 65 years
Being unvaccinatedor not being up to date on COVID-19 vaccinations
Specific medical conditions and behaviors

Does Lagevrio work? Why prescribe a medication for mild-moderate COVID-19?

Antiviral treatment of outpatients at risk for severe COVID-19 may reduce the risk of hospitalization and death.

In clinical trials done prior to authorization, Lagevrio was associated with an adjusted relative risk reduction of 30% in all-cause hospitalization or death through Day 29¹.

Observational data, including from Israel² and Hong Kong³, is consistent with benefit in high-risk patients:

46% risk reduction in hospitalizations and death compared to the untreated for patients 75 and older²
49% risk reduction in death compared to non-users³

References

https://www.nejm.org/doi/full/10.1056/NEJMoa2116044
Ronza Najjar-Debbiny et al. Clinical Infectious Diseases, 2022;, ciac781, https://doi.org/10.1093/cid/ciac781
Carlos K.H. et al. Lancet Infectious Disease 2022; doi: https://doi.org/10.1016/S1473-3099(22)00507-2

Do I need a prescription from a healthcare provider to receive treatment?

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

What is the current supply of Lagevrio? Do I need to prioritize prescribing based on supply?

There is currently ample supply of Lagevrio.

Lagevrio should be considered as a therapeutic alternative for any COVID-19 positive patient who meets the eligibility criteria and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

How will the U.S. Department of Health and Human Services determine how much Lagevrio is allocated to state and territorial health departments?

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.

Is Lagevrio available now?

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

How does a patient obtain Lagevrio if they need it?

An individual’s healthcare provider is the best first option for assessment and prescribing for patients who test positive for SARS-CoV-2.

Oral antivirals, including Lagevrio, are now available at more than 40,000 locations nationwide.

For individuals who do not have timely access to their own healthcare provider, there are more than 2,700 “Test-to-treat” sites where patients can get tested, assessed for COVID-19 therapeutic eligibility, and have their prescription filled. Telehealth options are also widely available.

How can I find Lagevrio in my area?

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.

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.

Are there any warnings or precautions that should be taken when prescribing Lagevrio?

Yes, health care providers and patients must be aware of the following warnings and precautions:

Lagevrio is not recommended for use during pregnancy because of risk it may cause fetal harm. Prior to initiating treatment with Lagevrio, health care providers should assess whether an individual of childbearing potential is pregnant or not, if clinically indicated.
Individuals of reproductive potential are advised to use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for appropriate time after the last dose per section 8.3 in the Fact Sheet for Healthcare Providers.
Breastfeeding is not recommended during treatment with Lagevrio and for 4 days after final dose.
Hypersensitivity reactions, including anaphylaxis, have been reported with Lagevrio. Please refer to the Lagevrio fact sheet for health care providers for additional information on warnings and precautions.

Are lab results required before a patient can be prescribed Lagevrio?

Patients must test positive for SARS-CoV-2 to be eligible; PCR or antigen tests, including at-home tests, are acceptable.

Licensed physicians and advanced practice providers are not required to perform additional laboratory testing when prescribing Lagevrio. Providers should use clinical judgement to determine if labs are necessary.