Lagevrio (EUA)

Molnupiravir is a product that the FDA is allowing to be given for emergency use to treat COVID-19. It is used by adults 18 years of age and older who have recently tested positive for coronavirus, have had mild to moderate symptoms for no more than 5 days and are not hospitalized. To receive this product you must also be at high risk for COVID-19 complications due to older age, obesity, or ongoing medical conditions (such as lung or heart disease or diabetes, among others). Talk to your doctor about the risks and benefits of treatment with molnupiravir.

Molnupiravir works by preventing the growth of the virus that causes COVID-19. More information about molnupiravir is available from the FDA Fact Sheet for Patients, Parents, and Caregivers for Emergency Use.

There is limited information about how safe and effective molnupiravir is for treating COVID-19. Study results show that molnupiravir may help people who have recently tested positive for coronavirus stay out of the hospital. This product is not for use by people who are hospitalized due to COVID-19.

The information in this document reflects emerging data, which is evolving and subject to reassessment. Users should be aware of these considerations in their review of molnupiravir, and it is always the responsibility of treating practitioners to exercise independent judgement in making care decisions.

Take this medication by mouth with or without food as directed by your doctor, usually every morning and evening, 12 hours apart, for 5 days. Swallow the capsules whole. Do not open, break, or crush the capsules. Let your doctor know if you cannot swallow the capsules whole. The dosage is based on your medical condition and response to treatment.

Continue to take this medication for the full time prescribed. Stopping the medication too early may allow the virus to continue to grow, which may result in a return of the infection or failure to protect you from the virus.

Tell your doctor if your condition lasts or gets worse.

Diarrhea, nausea, and dizziness may occur. If any of these effects last or get worse, tell your health care professional promptly.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Information is limited and it is unknown at this time if molnupiravir cause other serious side effects. This is not necessarily a complete list of possible side effects.

Contact your doctor for medical advice about side effects.

Before taking this medication, tell your doctor if you have any allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems.

Limited information is known at this time about other medical conditions that may affect how molnupiravir work, or how molnupiravir may affect other medical conditions.

Before using this medication, tell your doctor or pharmacist your medical history.

To avoid spreading the virus, you should continue to take precautions such as self-isolation, wearing a mask, social distancing (physical distancing), washing hands, and not sharing personal items.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while taking molnupiravir. Molnupiravir may harm an unborn baby. Your doctor may do a pregnancy test before you start taking this medication. Ask about reliable forms of birth control while using this medication and for 4 days after the last dose of molnupiravir. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is not known if this medication affects the sperm. Men with female partners of childbearing age should ask about the use of reliable forms of birth control while using this medication and for 3 months after stopping treatment.

It is unknown if molnupiravir passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 4 days after stopping the drug. Ask your doctor if you should pump and discard your breast milk during treatment and for 4 days after the last dose of this drug.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. Information is limited and it is unknown at this time if molnupiravir has drug interactions. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, take it as soon as you remember if it is less than 10 hours after the time you would usually take it. If more than 10 hours have passed, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

Lab and/or medical tests (such as pregnancy tests) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.