Lagevrio is an experimental medicine being studied for the treatment of mild-to-moderate COVID-19. This drug is still being studied and all of its risks are not yet known.

The US Food and Drug Administration (FDA) has authorized emergency use of molnupiravir for the treatment of mild-to-moderate COVID-19 in people 18 years of age and older:

• who are at high risk for progression to severe COVID-19, including hospitalization or death; and

• for whom other COVID-19 treatment options are not available or applicable.

Lagevrio is not authorized for use:

• for initiation of treatment in people needing hospitalization due to COVID-19;

• for prevention before or after exposure of COVID-19; or

• longer than 5 consecutive days.

Lagevrio may also be used for purposes not listed in this medication guide.

The US Food and Drug Administration (FDA) has authorized emergency use of molnupiravir for the treatment of mild-to-moderate COVID-19 in people 18 years of age and older.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Lagevrio (four capsules) every 12 hours for 5 consecutive days.

Take this medicine as soon as possible after diagnosis of COVID-19 and within 5 days of when symptoms first appear.

You may take Lagevrio with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Being treated with Lagevrio will not make you less contagious to other people. Keep using infection control methods such as self-isolation, social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

Lagevrio is still being studied and all of the risks are not yet known.

Tell your doctor if you have any serious or chronic disease.

Lagevrio may harm an unborn baby if the mother or father is using Lagevrio:

• If you are a woman, do not use Lagevrio if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 days after your last dose.

• If you are a man, use an effective birth control if your sex partner is pregnant or is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Lagevrio.

You may need to have a negative pregnancy test before starting this treatment.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of molnupiravir on the baby.

Do not breastfeed while using this medicine, and for at least 4 days after your last dose. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if you are more than 10 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have any new or worsening symptoms.

Common side effects of Lagevrio may include:

• diarrhea, nausea; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.