Lagevrio

Lagevrio is an experimental medicine being studied to treat mild-to-moderate COVID-19. This drug is still under investigation, and not all of its risks are known yet.

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

• who are at high risk for developing severe COVID-19, which includes hospitalization or death; and
• for whom other COVID-19 treatment options are not available or suitable.

Lagevrio is not authorized for use:

• in anyone younger than 18 years old;
• to start treatment in people who need to be hospitalized due to COVID-19;
• for prevention before or after exposure to COVID-19; or
• for more than 5 consecutive days.

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

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.

The contents of the open capsules may also be given through a feeding tube. Read and carefully follow the instructions provided on how to prepare a mixture of the open capsules. Ask your doctor or pharmacist if you do not understand these instructions.

Take this medicine as soon as possible after being diagnosed with COVID-19 and within 5 days of when symptoms first appear. Do not stop the medicine without your doctor's advice.

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 a protective face covering, disinfecting surfaces you touch often, and not sharing personal items with others.

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

Tell your doctor if you have any allergies or other medical conditions.

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 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.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, trouble swallowing, rapid heartbeat, 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.

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 help or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions regarding any limitations on food, drinks, or activities.

Other drugs may affect Lagevrio, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.