Patient profiles

Treating adult patients at high risk for progressing to severe COVID-19?
Consider LAGEVRIO (molnupiravir)

For certain adult patients with mild-to-moderate COVID-19, their medications and co-morbidities can impact COVID-19 treatment decisions. For these patients, consider LAGEVRIO.

Review several hypothetical patient cases below.

Jose – Atrial Fibrillation

Age: 64 | Sex: Male | Mild COVID-19

Clinical Scenario:

High risk for progressing to severe
COVID-19 due to multiple
comorbidities1

Takes daily medications primarily metabolized by CYP3A2-5

Presentation and diagnostic test:

  • Mild COVID-19 symptoms for 2-3 days
  • Positive test for SARS-CoV-2

Comorbidities:

  • Atrial fibrillation
  • BMI >30
  • Hypertension
  • Hypercholesterolemia

Current therapies:

  • Rivaroxabana 20 mg/day
  • Amiodaronea 400 mg/day
  • Amlodipinea 10 mg/day
  • Simvastatina 20 mg/day

aMetabolism depends on CYP3A.2-5

BMI, body mass index; COVID-19, coronavirus disease 2019; NHC, N4-hydroxycytidine; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

References:

  1. Centers for Disease Control and Prevention. Underlying medical conditions associated with higher risk for severe COVID-19: Information for healthcare professionals. Updated February 9, 2023. Accessed November 21, 2023. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html
  2. Cordarone. Prescribing Information. Pfizer; 2018.
  3. Xarelto. Prescribing Information. Janssen Pharmaceuticals; 2023.
  4. Zocor. Prescribing Information. Janssen Pharmaceuticals; 2023.
  5. Norvasc. Prescribing Information. Viatris Specialty LLC; 2023.

Lin – Coronary Artery Disease

Age: 59 | Sex: Female | Mild COVID-19

Clinical Scenario:

High risk for progressing to severe
COVID-19 due to underlying CAD1

Takes daily medications primarily
metabolized by CYP3A2,3

Presentation and diagnostic test:

  • Mild COVID-19 symptoms for 2-3 days
  • Positive test for SARS-CoV-2

Comorbidities:

  • CAD with recent PCI 
  • Hypertension
  • Hypercholesterolemia
  • Generalized anxiety disorder

Current therapies:

  • Clopidogrela 75 mg/day
  • Aspirin 81 mg/day
  • Metoprolol 50 mg/day
  • Rosuvastatin 10 mg/day
  • Alprazolama 2 mg/day

aMetabolism depends on CYP3A.2,3

CAD, coronary artery disease; COVID-19, coronavirus disease 2019; NHC, N4-hydroxycytidine; PCI, percutaneous coronary intervention; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

References:

  1. Centers for Disease Control and Prevention. Underlying medical conditions associated with higher risk for severe COVID-19: Information for healthcare professionals. Updated February 9, 2023. Accessed November 21, 2023. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html
  2. Plavix. Prescribing Information. Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership; 2022.
  3. Xanax. Prescribing Information. Pfizer; 2021.

Alan – Chronic Kidney Disease

Age: 70 | Sex: Male | Mild COVID-19

Clinical Scenario:

High risk for progressing to severe COVID-19 due to underlying CKD1

Takes daily medications primarily
metabolized by CYP3A2,3

Presentation and diagnostic test:

  • Mild COVID-19 symptoms for 2-3 days
  • Positive test for SARS-CoV-2

Comorbidities:

  • Chronic kidney disease 
  • Type 2 diabetes mellitus
  • Hypertension
  • Hypercholesteremia
  • BPH – benign prostatic hyperplasia

Current therapies:

  • Metformin 1,000 mg/day
  • Lisinopril 10 mg/day
  • Atorvastatina 40 mg/day
  • Tamsulosina 0.4 mg/day

aMetabolism depends on CYP3A.2,3

CKD, chronic kidney disease; COVID-19, coronavirus disease 2019; COVID-19, coronavirus disease 2019; NHC, N4-hydroxycytidine; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

References:

  1. Centers for Disease Control and Prevention. Underlying medical conditions associated with higher risk for severe COVID-19: Information for healthcare professionals. Updated February 9, 2023. Accessed November 21, 2023. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html
  2. Lipitor. Prescribing Information.Viatris Specialty LLC; 2024.
  3. Flomax. Prescribing Information. Astellas Pharma Inc; 2023.

For adult patients at risk for severe COVID-19, LAGEVRIO may be an appropriate option if their medications make other treatments clinically inappropriate*

*No clinical drug-drug interaction trials of LAGEVRIO with concomitant medications have been conducted

Help your patients understand how to take LAGEVRIO

The Dosing Brochure for LAGEVRIO is a convenient reference to help your patients with questions about dosing of LAGEVRIO.

Download the Dosing Brochure for LAGEVRIO.

EUA, emergency use authorization; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; COVID-19, coronavirus disease 2019.

Authorized Use

  • LAGEVRIO™ (molnupiravir) is authorized for use under an Emergency Use Authorization (EUA) 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 alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate
  • LAGEVRIO is not approved for any use, including the treatment of COVID-19, but is authorized for emergency use by the FDA under an Emergency Use Authorization (EUA).
  • The emergency use of LAGEVRIO is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the declaration is terminated or authorization revoked sooner.

Limitations of Authorized Use

  • LAGEVRIO is not authorized:
    • for use in patients who are less than 18 years of age
    • for initiation of treatment in patients hospitalized due to COVID-19. Benefit of treatment with LAGEVRIO has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19
    • for use for longer than 5 consecutive days
    • 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 (ie, anti-infectives).

Selected Safety Information

Contraindications

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

Warnings and Precautions

  • There are limited clinical data available for LAGEVRIO. Serious and unexpected adverse events may occur that have not been previously reported with LAGEVRIO use.
  • LAGEVRIO is not recommended for use during pregnancy. Based on findings from animal reproduction studies, LAGEVRIO may cause fetal harm when administered to pregnant individuals. There are no available human data on the use of LAGEVRIO in pregnant individuals to evaluate the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • LAGEVRIO is authorized to be prescribed to a pregnant individual only after the healthcare provider has determined that the benefits would outweigh the risks for that individual patient. If the decision is made to use LAGEVRIO during pregnancy, the prescribing healthcare provider must document that the known and potential benefits and the potential risks of using LAGEVRIO during pregnancy were communicated to the pregnant individual.
  • There is a pregnancy registry that monitors pregnancy outcomes in individuals exposed to LAGEVRIO during pregnancy. The prescribing healthcare provider must document that a pregnant individual was made aware of the pregnancy registry at https://covid-pr.pregistry.com or 1-800-616-3791. Pregnant individuals exposed to LAGEVRIO or their healthcare providers can also report the exposure by contacting Merck Sharp & Dohme LLC, Rahway, NJ, USA at 1-877-888-4231.
  • Advise individuals of childbearing potential of the potential risk to a fetus and to use an effective method of contraception correctly and consistently during treatment with LAGEVRIO and for 4 days after the final dose.
  • Prior to initiating treatment with LAGEVRIO, assess whether an individual of childbearing potential is pregnant or not, if clinically indicated.
  • Hypersensitivity reactions, including anaphylaxis, have been reported with LAGEVRIO. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue LAGEVRIO and initiate appropriate medications and/or supportive care.
  • LAGEVRIO is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. The safety and efficacy of LAGEVRIO have not been established in pediatric patients.

Adverse Reactions

  • The most common adverse reactions occurring in ≥1% of subjects in the LAGEVRIO treatment group in the Phase 3 double-blind MOVe-OUT study were diarrhea (2% versus placebo at 2%), nausea (1% versus placebo at 1%), and dizziness (1% versus placebo at 1%) all of which were Grade 1 (mild) or Grade 2 (moderate).

     

    Serious adverse events occurred in 7% of subjects receiving LAGEVRIO and 10% receiving placebo; most serious adverse events were COVID-19 related. Adverse events leading to death occurred in 2 (<1%) of the subjects receiving LAGEVRIO and 12 (2%) of subjects receiving placebo.

Drug interactions

  • No drug interactions have been identified based on the limited available data on the emergency use of LAGEVRIO. No clinical drug-drug interaction trials of LAGEVRIO with concomitant medications, including other treatments for mild-to-moderate COVID-19, have been conducted.

Pregnancy/Breastfeeding

  • There are no data on the presence of LAGEVRIO or its metabolites in human milk. It is unknown whether LAGEVRIO has an effect on the breastfed infant or effects on milk production. Based on the potential for adverse reactions in the infant from LAGEVRIO, breastfeeding is not recommended during treatment with LAGEVRIO and for 4 days after the final dose. A lactating individual may consider interrupting breastfeeding and may consider pumping and discarding breast milk during treatment and for 4 days after the last dose of LAGEVRIO.

Males of Reproductive Potential

  • Nonclinical studies to fully assess the potential for LAGEVRIO to affect offspring of treated males have not been completed. Advise sexually active individuals with partners of childbearing potential to use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose of LAGEVRIO. The risk beyond three months after the last dose of LAGEVRIO is unknown.

Required Reporting for Serious Adverse Events and Medication Errors

  • The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to LAGEVRIO within 7 calendar days from the healthcare provider’s awareness of the event.

     

    Submit adverse event and medication error reports, using FDA Form 3500, to FDA MedWatch using one of the following methods:

In addition, please provide a copy of all FDA MedWatch forms to:
Merck Sharp & Dohme LLC, Rahway, NJ, USA by:
Fax: 215-616-5677
Email: dpoc.usa@merck.com

 

Before prescribing LAGEVRIO, please read the accompanying Fact Sheet for Healthcare Providers, including Mandatory Requirements for Administration of LAGEVRIO Under Emergency Use Authorization. The FDA Letter of Authorization and the Fact Sheet for Patients and Caregivers also are available.

Authorized Use

  • LAGEVRIO™ (molnupiravir) is authorized for use under an Emergency Use Authorization (EUA) 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 alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate
  • LAGEVRIO is not approved for any use, including the treatment of COVID-19, but is authorized for emergency use by the FDA under an Emergency Use Authorization (EUA).
  • The emergency use of LAGEVRIO is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the declaration is terminated or authorization revoked sooner.

Limitations of Authorized Use

  • LAGEVRIO is not authorized:
    • for use in patients who are less than 18 years of age
    • for initiation of treatment in patients hospitalized due to COVID-19. Benefit of treatment with LAGEVRIO has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19
    • for use for longer than 5 consecutive days
    • 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 (ie, anti-infectives).
  • LAGEVRIO™ (molnupiravir) is authorized for use under an Emergency Use Authorization (EUA) for the treatment of adults…
  • LAGEVRIO™ (molnupiravir) is authorized for use under an Emergency Use Authorization (EUA) 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 alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate

Selected Safety Information for LAGEVRIO (molnupiravir)

Contraindications

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

Warnings and Precautions

  • There are limited clinical data available for LAGEVRIO. Serious and unexpected adverse events may occur that have not been previously reported with LAGEVRIO use.
  • LAGEVRIO is not recommended for use during pregnancy. Based on findings from animal reproduction studies, LAGEVRIO may cause fetal harm when administered to pregnant individuals. There are no available human data on the use of LAGEVRIO in pregnant individuals to evaluate the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • LAGEVRIO is authorized to be prescribed to a pregnant individual only after the healthcare provider has determined that the benefits would outweigh the risks for that individual patient. If the decision is made to use LAGEVRIO during pregnancy, the prescribing healthcare provider must document that the known and potential benefits and the potential risks of using LAGEVRIO during pregnancy were communicated to the pregnant individual.
  • There is a pregnancy registry that monitors pregnancy outcomes in individuals exposed to LAGEVRIO during pregnancy. The prescribing healthcare provider must document that a pregnant individual was made aware of the pregnancy registry at https://covid-pr.pregistry.com or 1-800-616-3791. Pregnant individuals exposed to LAGEVRIO or their healthcare providers can also report the exposure by contacting Merck Sharp & Dohme LLC, Rahway, NJ, USA at 1-877-888-4231.
  • Advise individuals of childbearing potential of the potential risk to a fetus and to use an effective method of contraception correctly and consistently during treatment with LAGEVRIO and for 4 days after the final dose.
  • Prior to initiating treatment with LAGEVRIO, assess whether an individual of childbearing potential is pregnant or not, if clinically indicated.
  • Hypersensitivity reactions, including anaphylaxis, have been reported with LAGEVRIO. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue LAGEVRIO and initiate appropriate medications and/or supportive care.
  • LAGEVRIO is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. The safety and efficacy of LAGEVRIO have not been established in pediatric patients.

Adverse Reactions

  • The most common adverse reactions occurring in ≥1% of subjects in the LAGEVRIO treatment group in the Phase 3 double-blind MOVe-OUT study were diarrhea (2% versus placebo at 2%), nausea (1% versus placebo at 1%), and dizziness (1% versus placebo at 1%) all of which were Grade 1 (mild) or Grade 2 (moderate).

     

    Serious adverse events occurred in 7% of subjects receiving LAGEVRIO and 10% receiving placebo; most serious adverse events were COVID-19 related. Adverse events leading to death occurred in 2 (<1%) of the subjects receiving LAGEVRIO and 12 (2%) of subjects receiving placebo.

Drug interactions

  • No drug interactions have been identified based on the limited available data on the emergency use of LAGEVRIO. No clinical drug-drug interaction trials of LAGEVRIO with concomitant medications, including other treatments for mild-to-moderate COVID-19, have been conducted.

Pregnancy/Breastfeeding

  • There are no data on the presence of LAGEVRIO or its metabolites in human milk. It is unknown whether LAGEVRIO has an effect on the breastfed infant or effects on milk production. Based on the potential for adverse reactions in the infant from LAGEVRIO, breastfeeding is not recommended during treatment with LAGEVRIO and for 4 days after the final dose. A lactating individual may consider interrupting breastfeeding and may consider pumping and discarding breast milk during treatment and for 4 days after the last dose of LAGEVRIO.

Males of Reproductive Potential

  • Nonclinical studies to fully assess the potential for LAGEVRIO to affect offspring of treated males have not been completed. Advise sexually active individuals with partners of childbearing potential to use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose of LAGEVRIO. The risk beyond three months after the last dose of LAGEVRIO is unknown.

Required Reporting for Serious Adverse Events and Medication Errors

  • The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to LAGEVRIO within 7 calendar days from the healthcare provider’s awareness of the event.

     

    Submit adverse event and medication error reports, using FDA Form 3500, to FDA MedWatch using one of the following methods:

In addition, please provide a copy of all FDA MedWatch forms to:
Merck Sharp & Dohme LLC, Rahway, NJ, USA by:
Fax: 215-616-5677
Email: dpoc.usa@merck.com

 

Before prescribing LAGEVRIO, please read the accompanying Fact Sheet for Healthcare Providers, including Mandatory Requirements for Administration of LAGEVRIO Under Emergency Use Authorization. The FDA Letter of Authorization and the Fact Sheet for Patients and Caregivers also are available.

Contraindications

  • No contraindications have been identified based on…

Contraindications

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

Warnings and Precautions

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