In order to mitigate the risks of using this unapproved product under the EUA and to optimize the potential benefit of LAGEVRIO, use of LAGEVRIO under this EUA has certain requirements. For more information, please review "Mandatory Requirements for Administration of LAGEVRIO Under Emergency Use Authorization" in the Fact Sheet for Healthcare Providers.
The dosage in adult patients is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days, with or without food. Take LAGEVRIO as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of symptom onset.
Completion of the full 5-day treatment course and continued isolation in accordance with public health recommendations are important to maximize viral clearance and minimize transmission of SARS-CoV-2.
LAGEVRIO is not authorized for use for longer than 5 consecutive days because the safety and efficacy have not been established.1
If the patient misses a dose of LAGEVRIO within 10 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If the patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.
Should a patient require hospitalization after starting treatment with LAGEVRIO, the patient may complete the full 5 day treatment course per the healthcare provider’s discretion.
Before prescribing LAGEVRIO, please read the accompanying Fact Sheet for Healthcare Providers, including Mandatory Requirements for Administration of LAGEVRIO Under Emergency Use Authorization. The FDA Letter of Authorization and the Fact Sheet for Patients and Caregivers are also available.
As a prescribing healthcare practitioner, you must communicate to the patient and/or caregiver information consistent with the “FACT SHEET FOR PATIENTS AND CAREGIVERS” and document that information was provided. A copy of this Fact Sheet should be provided to the patient and/or caregiver prior to receiving LAGEVRIO.
Inform patients that hypersensitivity reactions have been reported, even following a single dose of LAGEVRIO, and to discontinue the drug and to inform their healthcare provider at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.
Risk of Fetal Toxicity
Advise patients that LAGEVRIO is not recommended for use in pregnancy because it may cause fetal harm. Advise individuals of childbearing potential to inform their healthcare provider of a known or suspected pregnancy.
Advise individuals of childbearing potential to use effective contraception correctly and consistently while taking LAGEVRIO and for 4 days after the last dose.
While the risk is regarded as low, nonclinical studies to fully assess the potential for LAGEVRIO to affect offspring of treated males have not been completed. Advise sexually active individuals with partners of childbearing potential to use a reliable method of contraception consistently and correctly while taking LAGEVRIO and for at least 3 months after the last dose of LAGEVRIO. The risk beyond 3 months after the last dose of LAGEVRIO is unknown. Studies to understand the risk beyond three months are ongoing.
Risk of Bone and Cartilage Toxicity
LAGEVRIO is not authorized for use in patients less than 18 year of age as it may affect bone growth and cartilage formation.
Pregnancy Surveillance Program
There is a pregnancy surveillance program that monitors pregnancy outcomes in individuals exposed to LAGEVRIO during pregnancy. Encourage participation and advise patients about how they may enroll in the pregnancy surveillance program. Advise patients who have taken LAGEVRIO during pregnancy to report their pregnancy to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA at 1-877-888-4231 or pregnancyreporting.msd.com.
Breastfeeding is not recommended while taking LAGEVRIO and for 4 days after the last dose of LAGEVRIO. Advise lactating individuals to consider interrupting breastfeeding and to consider pumping and discarding breast milk during treatment and for 4 days after the last dose of LAGEVRIO.
Inform patients to take LAGEVRIO with or without food. Advise patients to swallow LAGEVRIO capsules whole, and to not open, break, or crush the capsules. Instruct patients that if they miss a dose of LAGEVRIO and it is within 10 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If the patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. Advise the patient to not double the dose to make up for a missed dose.
Alert the patient of the importance of completing the full 5-day treatment course and to continuing isolation in accordance with public health recommendations to maximize viral clearance and minimize transmission of SARS-CoV-2.
An EUA is a FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that there is a public health emergency that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include:
For information on clinical trials that are testing the use of LAGEVRIO for COVID-19, please visit www.clinicaltrials.gov.
No amino acid substitutions in SARS-CoV-2 associated with resistance to NHC have been identified in Phase 2 clinical trials evaluating LAGEVRIO for the treatment of COVID-19.
Studies to evaluate selection of resistance to NHC with SARS-CoV-2 in cell culture have not been completed.
Resistance selection studies have been conducted with other coronaviruses (MHV and MERS-CoV) and showed a low likelihood of resistance development to NHC.
Following 30 passages in cell culture, only a 2-fold decrease in susceptibility was observed and no NHC resistance-associated amino acid substitutions were identified. NHC retained activity in cell culture against virus with polymerase (nsp 12) substitutions (e.g., F480L, V557L and E802D) associated with decreased remdesivir sensitivity, indicating a lack of cross-resistance.
In clinical trials, encoded amino acid changes (substitutions, deletions or insertions) were more likely to be detected in viral sequences in subjects treated with LAGEVRIO compared to placebo. In a small number of subjects, amino acid changes in the spike protein occurred at positions targeted by monoclonal antibodies and vaccines. The clinical and public health significance of these changes are unknown.
The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events* and medication errors potentially related to LAGEVRIO within 7 calendar days from the healthcare provider’s awareness of the event, using FDA Form 3500 (for information on how to access this form, see below). The FDA requires that such reports, using FDA Form 3500, include the following:
Submit adverse event and medication error reports, using Form 3500, to FDA MedWatch using one of the following methods:
In addition, please provide a copy of all FDA MedWatch forms to:
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA
The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory responses to requests from FDA for information about adverse events and medication errors following receipt of LAGEVRIO.
*Serious adverse events are defined as:
Other therapeutics are currently authorized or approved for the same use as LAGEVRIO. For additional information on all products authorized for treatment or prevention of COVID-19, please see https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
The U. S. government is currently allocating the product. Dispensing sites should contact their state’s department of health or their eligible jurisdiction’s department of health for ordering instructions.
AmerisourceBergen will only ship what is allocated by the states. Ordering facilities that do not receive all the product they requested will have to contact their state's health department or eligible jurisdiction's health department regarding any additional quantities available.
Please contact your state’s or eligible jurisdiction’s department of health for ordering instructions.
No. Please set up an account with your state’s or eligible jurisdiction’s department of health, which will be placing orders for the time being.
Yes. Under the authorization, LAGEVRIO may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which LAGEVRIO belongs (i.e., anti-infectives).
To find U.S. Government-procured COVID-19 therapeutics, visit the U.S. Department of Health and Human Services' (HHS).a
aThis link will take you to a database that is owned and operated by HHS. Merck is not responsible for the content or maintenance of this site.
Yes. To fill a prescription for LAGEVRIO, patients require positive results from a direct SARS-CoV-2 viral test.