Pronunciation:

mol-nue-PIR-a-vir

Brand Names:

• Lagevrio

Dosage Forms:

• Capsule

Warnings:

In order to mitigate the risks of using this unapproved product under the EUA and to optimize the potential benefit of molnupiravir, the following steps are required. Use of molnupiravir under this EUA is limited to the following (all requirements must be met):Treatment of mild-to-moderate COVID-19 in adults with a positive result of direct severe acute respiratory syndrome coronavirus 2 (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.As the prescribing healthcare provider, review the information contained within the “Fact Sheet for Patients and Caregivers” with your patient or caregiver prior to the patient receiving molnupiravir. Healthcare providers must provide the patient/caregiver with an electronic or hard copy of the “Fact Sheet for Patients and Caregivers” prior to the patient receiving molnupiravir and must document that the patient/caregiver has been given an electronic or hard copy of the “Fact Sheet for Patients and Caregivers”.The prescribing healthcare providers must inform the patient/caregiver that: Molnupiravir is an unapproved drug that is authorized for use under this Emergency Use Authorization. Other therapeutics are currently approved or authorized for the same use as molnupiravir. There are benefits and risks of taking molnupiravir as outlined in the “Fact Sheet for Patients and Caregivers.” Merck Sharp & Dohme has established a pregnancy surveillance program. Females of childbearing potential should use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for 4 days after the last dose of molnupiravir. Males of reproductive potential who are sexually active with females of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose.The prescribing healthcare provider must assess whether a female of childbearing potential is pregnant or not, if clinically indicated.Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. If molnupiravir is used during pregnancy, prescribing healthcare providers must communicate to the patient the known and potential benefits and the potential risks of molnupiravir use during pregnancy, as outlined in the “Fact Sheet for Patients and Caregivers”.If the decision is made to use molnupiravir during pregnancy, the prescriber must document that the known and potential benefits and the potential risks of molnupiravir use during pregnancy, as outlined in the “Fact Sheet for Patients and Caregivers,” were discussed with the patient.The prescribing healthcare provider must document that a pregnant individual was made aware of Merck Sharp & Dohme’s pregnancy surveillance program at 1-877-888-4231 or pregnancyreporting.msd.com. If the pregnant individual agrees to participate in the pregnancy surveillance program and allows the prescribing healthcare provider to disclose patient specific information to Merck Sharp & Dohme, the prescribing healthcare provider must provide the patient’s name and contact information to Merck Sharp & Dohme.The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all medication errors and serious adverse events potentially related to molnupiravir within 7 calendar days from the healthcare provider’s awareness of the event.For information on clinical studies of molnupiravir and other therapies for the treatment of COVID-19, see www.clinicaltrials.gov .

Classifications:

Therapeutic—

Antiviral

Uses of This Medicine:

Molnupiravir is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in non-hospitalized patients who are at high risk for progression to severe COVID-19 (eg, hospitalization, death) or in patients for whom other authorized or approved COVID-19 vaccines are not accessible or appropriate.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of molnupiravir in the pediatric population. Molnupiravir may affect bone growth and cartilage formation in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of molnupiravir in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Fact Sheet for Patients and Caregivers. Read and follow the information in the Fact Sheet carefully. Ask your doctor if you have any questions.

Take this medicine within 5 days of the onset of COVID-19 symptoms.

Swallow the capsule whole with a glass of water. Do not crush, open, or chew it. You may take this medicine with or without food.

You may also give the medicine through a nasogastric tube or orogastric tube:

• You may open the capsule in a container with a lid and mix with 40 mL of water.
• Put the lid back and shake the mixture for 3 minutes. The contents may not dissolve completely.
• Flush the tube with 5 mL of water. Using a syringe, draw the mixture from the container and give it right away. Do not keep the mixture for later use.
• Add 10 mL of water into the container. Repeat this step until no capsule contents are left in the container or syringe. Flush the tube with 5 mL of water 2 times after giving the mixture.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For treatment of mild to moderate COVID-19:
    • Adults—800 milligrams (mg) (4 capsules) every 12 hours for 5 days.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is within 10 hours of the time it is usually taken, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is more than 10 hours, skip the missed dose and take your next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for any unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 4 days after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Diarrhea

dizziness

headache

hives, itching, skin rash

nausea

redness of the skin

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.