FULL FACT SHEET FOR HEALTHCARE PROVIDERS

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product LAGEVRIO™ for treatment of adults with mild-to-moderate coronavirus disease 2019 (COVID-19):

• who are at high risk for progression to severe COVID-19, including hospitalization or death. Refer to CDC website1 for additional details, and for
• whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

LIMITATIONS OF AUTHORIZED USE

• LAGEVRIO is not authorized for use in patients who are less than 18 years of age [see Warnings and Precautions (5.3)].
• LAGEVRIO is not authorized for initiation of treatment in patients hospitalized due to COVID-192. Benefit of treatment with LAGEVRIO has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19 [see Dosing and Administration (2.1)].
• LAGEVRIO is not authorized for use for longer than 5 consecutive days.
• LAGEVRIO is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

LAGEVRIO may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which LAGEVRIO belongs (i.e., anti-infectives).

LAGEVRIO is not approved for any use, including for use for the treatment of COVID-19.

Prior to initiating treatment with LAGEVRIO, carefully consider the known and potential risks and benefits [see Warnings and Precautions (5.1, 5.3), Use in Specific Populations (8.1, 8.3) and Nonclinical Toxicology (13.1)].

LAGEVRIO is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of LAGEVRIO under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Justification for Emergency Use of Drugs During the COVID-19 Pandemic

There is currently an outbreak of Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2, a novel coronavirus. The Secretary of HHS has:

• Determined that there is a public health emergency, or significant potential for a public health emergency, related to COVID-193.
• Declared that circumstances exist justifying the authorization of emergency use of drugs and biological products for the prevention or treatment of COVID-194.

An EUA is a FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that there is a public health emergency that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include:

• The biological agent(s) can cause a serious or life-threatening disease or condition;
• Based on the totality of the available scientific evidence (including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that
  • the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition; and
  • the known and potential benefits of the product - when used to diagnose, prevent, or treat such disease or condition - outweigh the known and potential risks of the product, taking into consideration the material threat posed by the biological agent(s);
• There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the serious or life-threatening disease or condition.

APPROVED AVAILABLE ALTERNATIVES

Veklury (remdesivir) is FDA-approved for the treatment of COVID-19 in adults and pediatric patients (at least 28 days old and weighing at least 3 kg) who are not hospitalized and have mild-to-moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Veklury is administered via intravenous infusion for a total treatment duration of 3 days.

Although Veklury is an approved alternative to LAGEVRIO for the treatment of mild-to-moderate COVID-19 in adults and who are at high risk for progression to severe COVID-19, including hospitalization or death, FDA does not consider Veklury to be an adequate alternative to LAGEVRIO for this authorized use because it may not be feasible or clinically appropriate for certain patients (e.g., it requires a 3-day intravenous treatment duration).

Paxlovid (nirmatrelvir tablets; ritonavir tablets co-packaged for oral use) is FDA-approved for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is administered orally for a total treatment duration of 5 days. Although Paxlovid is an approved alternative to LAGEVRIO for the treatment of mild-to-moderate COVID-19 in adults and who are at high risk for progression to severe COVID-19, including hospitalization or death, FDA does not consider Paxlovid to be an adequate alternative to LAGEVRIO for this authorized use because it may not be clinically appropriate for patients on medications that are primarily metabolized by CYP3A and/or that are strong CYP3A inducers.

For additional information on all products authorized for treatment or prevention of COVID-19, please see https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization .

For information on clinical studies of LAGEVRIO and other therapies for the treatment of COVID-19, see www.clinicaltrials.gov.

1

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html . Healthcare providers should consider the benefit-risk for an individual patient.

2

Should a patient require hospitalization after starting treatment with LAGEVRIO, the patient may complete the full 5 day treatment course per the healthcare provider’s discretion.

3

See U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020; https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency. See also U.S. Department of Health and Human Services, Amended Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b). March 15, 2023 (“Amended Determination”); https://www.federalregister.gov/documents/2023/03/20/2023-05609/covid-19-emergency-use-authorization-declaration.

4

See U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250 (April 1, 2020); https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration. See also Amended Determination (“The declarations issued pursuant to section 564(b)(1) of the FD&C Act that circumstances exist justifying the authorization of emergency use of certain in vitro diagnostics, personal respiratory protective devices, other medical devices and drugs and biological products, as set forth in those declarations, and that are based on the February 4, 2020 determination, remain in effect until those declarations are terminated in accordance with section 564 of the FD&C Act.”).

Capsules: 200 mg, Swedish Orange opaque size 0 capsules. The capsules have the corporate logo and “82” printed in white ink.

No contraindications have been identified based on the limited available data on the emergency use of LAGEVRIO authorized under this EUA.

There are limited clinical data available for LAGEVRIO. Serious and unexpected adverse events may occur that have not been previously reported with LAGEVRIO use.

No drug interactions have been identified based on the limited available data on the emergency use of LAGEVRIO authorized under this EUA. No clinical drug-drug interaction trials of LAGEVRIO with concomitant medications, including other treatments for mild-to-moderate COVID-19, have been conducted [see Clinical Pharmacology (12.3)].

There is no human experience of overdosage with LAGEVRIO. Treatment of overdose with LAGEVRIO should consist of general supportive measures including the monitoring of the clinical status of the patient. Hemodialysis is not expected to result in effective elimination of NHC.

LAGEVRIO capsules contain molnupiravir, a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis and is the 5´-isobutyrate ester of the ribonucleoside analog N4-hydroxycytidine (NHC).

The chemical name for molnupiravir is {(2R,3S,4R,5R)-3,4-Dihydroxy-5-[(4Z)-4-(hydroxyimino)-2-oxo-3,4-dihydropyrimidin-1(2H)-yl]oxolan-2-yl}methyl 2-methylpropanoate. It has an empirical formula of C13H19N3O7 and its molecular weight is 329.31 g/mol. Its structural formula is:

Molnupiravir is a white to off-white powder that is soluble in water.

Each LAGEVRIO capsule, for oral use, contains 200 mg of molnupiravir and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose and purified water. The capsule shell is made of hypromellose, red iron oxide and titanium dioxide. The capsule is printed with white ink made of butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide.

Clinical data supporting this EUA are based on data from 1,433 randomized subjects in the Phase 3 MOVe-OUT trial (NCT04575597). MOVe-OUT is a randomized, placebo-controlled, double-blind clinical trial studying LAGEVRIO for the treatment of non-hospitalized patients with mild-to-moderate COVID-19 who are at risk for progressing to severe COVID-19 and/or hospitalization. Eligible subjects were 18 years of age and older and had one or more pre-defined risk factors for disease progression: over 60 years of age, diabetes, obesity (BMI ≥30), chronic kidney disease, serious heart conditions, chronic obstructive pulmonary disease, or active cancer. The study included symptomatic subjects not vaccinated against SARS-CoV-2 and who had laboratory confirmed SARS-CoV-2 infection and symptom onset within 5 days of randomization. Subjects were randomized 1:1 to receive 800 mg of LAGEVRIO or placebo orally twice daily for 5 days.

At baseline, in all randomized subjects, the median age was 43 years (range:18 to 90); 17% of subjects were over 60 years of age and 3% were 75 years of age or older; 49% of subjects were male; 57% were White, 5% Black or African American, 3% Asian, 50% Hispanic or Latino. The majority of subjects were enrolled from sites in Latin America (46%) and Europe (33%); 12% were enrolled in Africa, 6% were enrolled in North America and 3% were enrolled in Asia. Forty-eight percent of subjects received LAGEVRIO or placebo within 3 days of COVID-19 symptom onset. The most common risk factors were obesity (74%), over 60 years of age (17%), and diabetes (16%). Among 792 subjects (55% of total randomized population) with available baseline SARS-CoV-2 variant/clade identification results, 58% were infected with Delta (B.1.617.2 and AY lineages), 20% were infected with Mu (B.1.621), 11% were infected with Gamma (P.1), and the remainder were infected with other variants/clades. Overall, baseline demographic and disease characteristics were well balanced between the treatment arms.

Table 3 provides the results of the primary endpoint (the percentage of subjects who were hospitalized or died through Day 29 due to any cause). The efficacy results are based on unvaccinated adults who were 18 years of age and older and had one or more pre-defined risk factors for disease progression: over 60 years of age, diabetes, obesity (BMI ≥30), chronic kidney disease, serious heart conditions, chronic obstructive pulmonary disease, or active cancer. Please refer to Figure 1 for results by certain subgroups. These subgroup analyses are considered exploratory. Data are not available in certain subgroups of subjects who are at high risk for progression to severe COVID-19 as defined by CDC.

Figure 1. Subgroup Efficacy Results in Non-Hospitalized Adults with COVID-19 - All-Randomized Subjects

The corresponding confidence interval is based on Miettinen & Nurminen method.

The modified intent-to-treat population is the efficacy analysis population.

Baseline serum samples were evaluated with the Roche Elecsys anti-N assay to test for the presence of antibodies (IgM, IgG and IgA) against the SARS-CoV-2 nucleocapsid protein.

The findings of these subgroup analyses are considered exploratory.

Product: 50090-6841

NDC: 50090-6841-0 40 CAPSULE in a BOTTLE, PLASTIC

As a prescribing healthcare practitioner, you must communicate to the patient and/or caregiver information consistent with the “FACT SHEET FOR PATIENTS AND CAREGIVERS” and document that information was provided. A copy of this Fact Sheet should be provided to the patient and/or caregiver prior to receiving LAGEVRIO [see Box].

Hypersensitivity Reactions

Inform patients that hypersensitivity reactions have been reported, even following a single dose of LAGEVRIO, and to discontinue the drug and to inform their healthcare provider at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction [see Warnings and Precautions (5.2)].

Risk of Fetal Toxicity

Advise patients that LAGEVRIO is not recommended for use in pregnancy because it may cause fetal harm. Advise individuals of childbearing potential to inform their healthcare provider of a known or suspected pregnancy [see Box, Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Advise individuals of childbearing potential to use effective contraception correctly and consistently while taking LAGEVRIO and for 4 days after the last dose.

While the risk is regarded as low, there is a theoretical risk for LAGEVRIO to affect offspring of treated males based on its mechanism of action. Advise sexually active individuals with partners of childbearing potential to use a reliable method of contraception correctly and consistently while taking LAGEVRIO and for at least 3 months after the last dose of LAGEVRIO. The risk beyond 3 months after the last dose of LAGEVRIO is unknown [see Use in Specific Populations (8.3)].

Risk of Bone and Cartilage Toxicity

LAGEVRIO is not authorized for use in patients less than 18 year of age as it may affect bone growth and cartilage formation [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4)].

Pregnancy Registry

There is a pregnancy registry that monitors pregnancy outcomes in individuals exposed to LAGEVRIO during pregnancy. Encourage participation and advise patients about how they may enroll in the pregnancy registry at https://covid-pr.pregistry.com or 1-800-616-3791 [see Use in Specific Populations (8.1)].

Lactation

Breastfeeding is not recommended while taking LAGEVRIO and for 4 days after the last dose of LAGEVRIO. Advise lactating individuals to consider interrupting breastfeeding and to consider pumping and discarding breast milk during treatment and for 4 days after the last dose of LAGEVRIO [see Use in Specific Populations (8.2)].

Administration Instructions

Inform patients to take LAGEVRIO with or without food. Advise patients to swallow LAGEVRIO capsules whole, and to not open, break, or crush the capsules. Instruct patients that if they miss a dose of LAGEVRIO and it is within 10 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If the patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. Advise the patient to not double the dose to make up for a missed dose [see Dosage and Administration (2.2)].

LAGEVRIO capsule contents can be mixed with water and given via NG/OG, G and GJ tubes. Inform patients to follow the instructions as described in the fact sheet for patients and caregivers [see Dosage and Administration (2.3)].

Alert the patient of the importance of completing the full 5-day treatment course and to continuing isolation in accordance with public health recommendations to maximize viral clearance and minimize transmission of SARS-CoV-2 [see Dosage and Administration (2.1)].

For additional information visit: www.molnupiravir.com

If you have questions, please contact
1-800-672-6372

Manuf. for: Merck Sharp & Dohme LLC
Rahway, NJ 07065, USA

For patent information: www.msd.com/research/patent
Copyright © 2021-2024 Merck & Co., Inc., Rahway, NJ, USA and its affiliates.
All rights reserved.
usfshcp-mk4482-c-2406r010

What is the most important information I should know about LAGEVRIO?

LAGEVRIO may cause serious side effects, including:

• LAGEVRIO may cause harm to your unborn baby. It is not known if LAGEVRIO will harm your baby if you take LAGEVRIO during pregnancy.
  • LAGEVRIO is not recommended for use in pregnancy.
  • LAGEVRIO has not been studied in pregnancy. LAGEVRIO was studied in pregnant animals only. When LAGEVRIO was given to pregnant animals, LAGEVRIO caused harm to their unborn babies.
  • You and your healthcare provider may decide that you should take LAGEVRIO during pregnancy if there are no other COVID-19 treatment options approved or authorized by the FDA that are accessible or clinically appropriate for you.
  • If you and your healthcare provider decide that you should take LAGEVRIO during pregnancy, you and your healthcare provider should discuss the known and potential benefits and the potential risks of taking LAGEVRIO during pregnancy.

For individuals who are able to become pregnant:

• You should use a reliable method of birth control (contraception) correctly and consistently during treatment with LAGEVRIO and for 4 days after the last dose of LAGEVRIO. Talk to your healthcare provider about reliable birth control methods.
• Before starting treatment with LAGEVRIO your healthcare provider may do a pregnancy test to see if you are pregnant before starting treatment with LAGEVRIO.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LAGEVRIO.

Pregnancy Registry:

• There is a pregnancy registry for individuals who take LAGEVRIO during pregnancy. The purpose of this program is to collect information about the health of you and your baby.
• If you are pregnant or become pregnant during treatment with LAGEVRIO, you are encouraged to report your use of LAGEVRIO during pregnancy to this pregnancy registry at https://covid-pr.pregistry.com or 1-800-616-3791.

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

• It is not known if LAGEVRIO can affect sperm, but the risk is regarded as low based on animal studies.
• You should use a reliable method of birth control (contraception) correctly and consistently during treatment with LAGEVRIO and for at least 3 months after the last dose. Talk to your healthcare provider about reliable birth control methods.
• The risk to sperm beyond 3 months is not known. Talk to your healthcare provider if you have questions or concerns about how LAGEVRIO may affect sperm.

You are being given this fact sheet because your healthcare provider believes it is necessary to provide you with LAGEVRIO for the treatment of adults with mild-to-moderate coronavirus disease 2019 (COVID-19) who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom other COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make LAGEVRIO available during the COVID-19 pandemic (for more details about an EUA please see “What is an Emergency Use Authorization?” at the end of this document). LAGEVRIO is not an FDA-approved medicine in the United States. Read this Fact Sheet for information about LAGEVRIO. Talk to your healthcare provider about your options if you have any questions. It is your choice to take LAGEVRIO.

What is COVID-19?

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.

What is LAGEVRIO?

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

• who are at high risk for progression to severe COVID-19 including hospitalization or death, and for
• whom other COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

The FDA has authorized the emergency use of LAGEVRIO for the treatment of mild-to-moderate COVID-19 in adults under an EUA. For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.

LAGEVRIO is not authorized:

• for use in people less than 18 years of age.
• for prevention of COVID-19.
• for people needing hospitalization for COVID-19.
• for use for longer than 5 consecutive days.

What should I tell my healthcare provider before I take LAGEVRIO?

Tell your healthcare provider if you:

• have any allergies
• are breastfeeding or plan to breastfeed
• have any serious illnesses
• take any medicines including prescription, over-the-counter medicines, vitamins, and herbal products.

How do I take LAGEVRIO?

• Take LAGEVRIO exactly as your healthcare provider tells you to take it.
• Take 4 capsules of LAGEVRIO every 12 hours (for example, at 8 am and at 8 pm)
• Take LAGEVRIO for 5 days. It is important that you complete the full 5 days of treatment with LAGEVRIO. Do not stop taking LAGEVRIO before you complete the full 5 days of treatment, even if you feel better.
• Take LAGEVRIO with or without food.
• You should stay in isolation for as long as your healthcare provider tells you to. Talk to your healthcare provider if you are not sure about how to properly isolate while you have COVID-19.
• Swallow LAGEVRIO capsules whole. Do not open, break, or crush the capsules. If you cannot swallow capsules whole, tell your healthcare provider.
• If your healthcare provider prescribes LAGEVRIO and tells you to take or give a dose through a nasogastric (NG), orogastric (OG), gastrostomy (G) or gastrojejunostomy (GJ) feeding tube, follow the instructions below: “How to take or give a dose of LAGEVRIO through a nasogastric (NG), orogastric (OG), gastrostomy (G) or gastrojejunostomy (GJ) feeding tube.” You must have an NG, OG, or G feeding tube that is size 12 French or larger, or a GJ feeding tube that is 14 French or larger.
• If you miss a dose of LAGEVRIO:
  • If it has been less than 10 hours since the missed dose, take it as soon as you remember.
  • If it has been more than 10 hours since the missed dose, skip the missed dose and take your dose at the next scheduled time.
• Do not double the dose of LAGEVRIO to make up for a missed dose.

How to take or give a dose of LAGEVRIO through a nasogastric (NG), orogastric (OG), gastrostomy (G) or gastrojejunostomy (GJ) feeding tube:

• Wash your hands well with soap and water.
• Gather the supplies you will need to take or give the prescribed dose of LAGEVRIO.
  • 4 LAGEVRIO capsules
  • 1 liquid measuring cup with mL markings to measure 40 mL of room temperature water
  • 1 clean container with a lid
  • 1 syringe. Your healthcare provider should tell you what size syringe you will need to take or give a dose of LAGEVRIO.
• Place the needed supplies on a clean work surface.
• Follow your healthcare provider’s instructions on how to flush the feeding tube. Flush the feeding tube with 5 mL of water before taking or giving a dose of LAGEVRIO.
• Carefully open 4 LAGEVRIO capsules, one at a time, and empty the contents into a clean container. Discard (throw away) the capsules shells in the household trash.
• Use the liquid measuring cup to measure 40 mL of room temperature water and add to the container containing the capsule contents.
• Place the lid on the container. Shake to mix the capsule contents and water well for 3 minutes. The capsule contents may not dissolve completely.
• Remove the lid from the container and draw up all the LAGEVRIO and water mixture into a syringe.
• Give all of the mixture right away through the feeding tube. If using a GJ tube, give the mixture through the gastric port. Do not keep the mixture for future use.
• If any capsule contents are left in the container:
  • Add 10 mL of water to the container and mix to loosen any capsule contents that are left in the container.
  • Use the syringe to draw up all of the mixture in the container.
  • Give the mixture through the feeding tube.
  • Repeat this process as needed until you no longer see any capsule contents left in the container or syringe.
• Use the same syringe to flush the feeding tube 2 times with 5 mL of water (10 mL total).
• Rinse the container, lid and syringe well with clean water after use. Place on a clean paper towel until next use.

What are the important possible side effects of LAGEVRIO?

• See, “What is the most important information I should know about LAGEVRIO?”
• Allergic Reactions. Allergic reactions can happen in people taking LAGEVRIO, even after only 1 dose. Stop taking LAGEVRIO and call your healthcare provider right away if you get any of the following symptoms of an allergic reaction:
  • hives
  • rapid heartbeat
  • trouble swallowing or breathing
  • swelling of the mouth, lips, or face
  • throat tightness
  • hoarseness
  • skin rash

The most common side effects of LAGEVRIO are:

• diarrhea
• nausea
• dizziness

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.

What other treatment choices are there?

Veklury (remdesivir) is FDA-approved as an intravenous (IV) infusion for the treatment of mild-to-moderate COVID-19 in certain adults and children. Paxlovid (nirmatrelvir/ritonavir) is FDA-approved as tablets for the treatment of mild-to-moderate COVID-19 in certain adults. Talk with your doctor to see if Veklury or Paxlovid are appropriate for you.

Like LAGEVRIO, FDA may also 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.

What if I am breastfeeding?

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.

How do I report side effects with LAGEVRIO?

Contact your healthcare provider if you have any side effects that bother you or do not go away.

Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

How should I store LAGEVRIO?

• Store LAGEVRIO capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep LAGEVRIO and all medicines out of the reach of children.

How can I learn more about COVID-19?

• Ask your healthcare provider.
• Visit www.cdc.gov/COVID19.
• Contact your local or state public health department.
• Call Merck Sharp & Dohme at 1-800-672-6372 (toll free in the U.S.)
• Visit www.molnupiravir.com.

What Is an Emergency Use Authorization (EUA)?

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 is authorized for emergency use for the treatment of adults with mild-to-moderate COVID-19 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.

LAGEVRIO as a treatment for COVID-19, has not undergone the same type of review as an FDA-approved product. The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID-19 pandemic.

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).

Manuf. for: Merck Sharp & Dohme LLC
Rahway, NJ 07065, USA

For patent information: www.msd.com/research/patent
Copyright © 2021-2024 Merck & Co., Inc., Rahway, NJ, USA and its affiliates.
All rights reserved.

usfsp-mk4482-c-2406r006

Revised: June 2024