Molnupiravir photo
Photo source: Merck
Last updated 26 December 2021. Information on this topic is rapidly changing and may render the following incomplete or inaccurate.
KEY POINTS
- Molnupiravir (Lagevrio, MK-4482, EIDD-2801) is a ribonucleoside analog antiviral medication that inhibits the replication of SARS-CoV-2
- Molnupiravir is a prodrug that is metabolised to the ribonucleoside analogue N-hydroxycytidine (NHC) which distributes into cells where it is phosphorylated to form the pharmacologically active ribonucleoside triphosphate (NHC-TP). NHC-TP acts by a mechanism known as viral error catastrophe. NHC-TP incorporation into viral RNA by the viral RNA polymerase, results in an accumulation of errors in the viral genome leading to inhibition of replication.
- Molnupiravir was approved for use in the UK on 4 November 2021 to treat mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness
- Molnupiravir gained FDA Emergency Use Authorization on 23 December 2021 for treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.
- FDA held an Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment
- Voted 13 yes, 10 no to move forward with EUA release
- FDA held an Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment
- Should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset
- Dosed as 800 mg BID x5 days
- Comes in a 200 mg capsules, so is 4 pills per dose and 40 pills per course
- No renal or hepatic dose adjustment required
- May be taken with or without food, should not be crushed
- Dosed as 800 mg BID x5 days
- Under FDA EUA may be continued if patient hospitalized during treatment
- Under FDA EUA may be initiated in a hospitalized person who is not in the hospital for COVID-19 (see FAQ)
- No drug-drug interactions known
- Has warnings for embryo-fetal toxicity as well as bone and cartilage toxicity
- Pregnancy data is lacking, use during pregnancy is not recommended
- There is a pregnancy surveillance program
- Note FDA only for persons 18 years and older
- Pregnancy data is lacking, use during pregnancy is not recommended
- The most commonly reported adverse reactions have been diarrhea (3%), nausea (2%), dizziness (1%) and headache (1%)
- See HCP Fact Sheet for more details
RESOURCES
- Molnupiravir Fact Sheet for Healthcare Providers
- Molnupiravir Fact Sheet for Patients and Caregivers
- FDA’s Frequently Asked Questions on the Emergency Use Authorization for Molnupiravir for Treatment of COVID-19
- US HHS Public Health Emergency Webpage on Molnupiravir
- US HHS ASPR Frequently Asked Questions – Molnupiravir
- FDA Letter of Emergency Use Authorization for Molnupiravir
- Regulatory approval of Lagevrio (molnupiravir) – UK Government Website
- November 30, 2021: Antimicrobial Drugs Advisory Committee Meeting Announcement – FDA
- Unmet need for COVID-19 therapies in community settings – Lancet ID
- β-D–N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells – JID
- COVID antiviral pills: what scientists still want to know – NATURE news explainer
- Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives First Authorization in the World News Release
- Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study News Release
