MOLNUPIRAVIR – Oral Antiviral Treatment for COVID-19
The FDA has recently granted emergency use authorization (EUA) for molnupiravir (Lagevrio). Molnupiravir is an antiviral agent. In a recent clinical trial, molnupiravir reduced the risk of hospitalization and death by 30%.
The EUA specifies that Molnupiravir is for the treatment of mild-to-moderate coronavirus disease 2019 (COVID19) 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. Molnupiravir is not authorized for use in patients less than 18 years of age. It is not authorized for initiation of treatment in patients requiring hospitalization due to COVID-19 or for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days, with or without food.
Initiate treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
Swallow capsules whole; do not open, break, or crush.
If a dose is missed within 10 hours of usual administration time, administer the missed dose as soon as possible, and resume normal dosing schedule. If a dose is missed by more than 10 hours, do not administer the missed dose, and resume dosing at the next scheduled administration time. Do not double the dose to make up for a missed dose (FDA 2021).
Reduced renal function or hepatic impairment:
No dose adjustment necessary.
Refer to EUA for information regarding reporting adverse reactions (FDA 2021). Adverse reactions reported in adults: Diarrhea, Nausea, dizziness.
Warnings and Precautions:
Embryo-Fetal Toxicity: Molnupiravir is not recommended for use during pregnancy.
(5.1, 8.1, 8.3) • 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.
No contraindications have been identified based on the limited available data on the emergency use of molnupiravir authorized under the EUA.
No drug interactions have been identified based on the limited available data on the emergency use of molnupiravir authorized under the EUA.
Distribution of this medication is being managed by state and federal agencies.