Molnupiravir Emergency Use Authorization (EUA)

On December 23, 2021, the FDA issued an EUA for molnupiravir for the treatment of mild to moderate COVID 19 in eligible high-risk patients for whom alternative COVID - 19 treatment options are not accessible or clinically appropriate. Molupiravir is a nucleoside analogue that inhibits SARS-CoV-2 by viral mutagenesis. At this time, Molnupiravir is NOT authorized for individuals less than 18 years of age, for hospitalized patients, for use for longer than 5 days, or for individuals who are pregnant/and or breastfeeding.

Prescribers must comply with requirements of the US Food and Drug Administration's Fact Sheet for Healthcare Providers: Emergency Use Authorization for Molnupiravir and with the State of Michigan Priority Eligibility Criteria and prescribing requirements for this medication. Patients must have tested positive for SARS-CoV-2.

 

Molnupiravir is indicated for the treatment of mild-to-moderate (COVID-19) in adults (18 years of age), and

  • with positive results of direct (SARS-CoV-2) viral testing, and
  • who are at high risk for progression 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, and
  • who meet the current Priority Eligibility Criteria.

 

Dosing and Administration of Molnupiravir (see full Fact Sheet for Healthcare Providers)

  • 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days, with or without food.
  • Take molnupiravir as soon as possible after a diagnosis of COVID19 has been made, and within 5 days of symptom onset. 
  • Completion of the full 5-day treatment course and continued isolation in accordance with public health recommendations are important to maximize viral clearance and minimize transmission of SARS-CoV-2.
  • Molnupiravir is not authorized for use for longer than 5 consecutive days because the safety and efficacy have not been established.

 

Dosage Forms of Molnupiravir

  • Capsules: 200 mg

 

Warning and Precautions for Molnupiravir

  • Use in Pregnancy /Embryo-Fetal Toxicity: Molnupiravir is not recommended for use during pregnancy.
  • Bone and Cartilage Toxicity: Molnupiravir is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth.

 

Contraindications for Molnupiravir

  • No contraindications have been identified based on the limited available data on the emergency use of molnupiravir authorized under this EUA.
  • Not to be used in pregnancy

 

All adverse reactions and medication errors must be reported to the FDA using FDA form 3500 FDA ADVERSE REACTIONS.