Patient FAQs for LAGEVRIO™ (molnupiravir)

LAGEVRIO may cause serious side effects, including:

For individuals who are able to become pregnant:

Pregnancy Registry:

For individuals who are sexually active with partners who are able to become pregnant:

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 pandemic. LAGEVRIO for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 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 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, or a serious or life-threatening disease or condition caused by COVID-19; 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.

All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. The EUA for LAGEVRIO is in effect for the duration of the COVID-19 declaration justifying emergency use of LAGEVRIO, unless terminated or revoked (after which LAGEVRIO may no longer be used under the EUA).

LAGEVRIO is an investigational medicine used to treat mild-to-moderate COVID-19 in adults:

LAGEVRIO is not authorized:

No, it is not a vaccine. LAGEVRIO is an investigational medicine used to treat mild-to-moderate COVID-19 in certain adults.

Yes, LAGEVRIO is a prescription medication.

Tell your healthcare provider if you:

Patients must have private insurance with coverage for LAGEVRIO in order to be eligible for the coupon.

LAGEVRIO may cause harm to your unborn baby. It is not known if LAGEVRIO will harm your baby if you take LAGEVRIO during pregnancy.

For individuals who are able to become pregnant:

Pregnancy Registry:

For individuals who are sexually active with partners who are able to become pregnant:

Breastfeeding is not recommended during treatment with LAGEVRIO and for 4 days after the last dose of LAGEVRIO. If you are breastfeeding or plan to breastfeed, talk to your healthcare provider about your options and specific situation before taking LAGEVRIO.

LAGEVRIO can be taken with or without food. Take LAGEVRIO exactly as your healthcare provider tells you to take it.

The most common side effects of LAGEVRIO are:

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.

Like LAGEVRIO, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization for more information.

It is your choice to be treated or not to be treated with LAGEVRIO. Should you decide not to take it, it will not change your standard medical care.

COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through close contact with another person who has the virus.

COVID-19 illnesses have ranged from very mild-to-severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. Older people and people of all ages with severe, long lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example seem to be at higher risk of being hospitalized for COVID-19.