December 23, 2021
The U.S. FDA has issued emergency use authorization (EUA) for molnupiravir, manufactured by Merck, to treat mild-to-moderate COVID-19 in adults 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 the FDA are not accessible or clinically appropriate. Patients must have positive results of direct SARS-CoV-2 viral testing.
- The FDA has emphasized that molnupiravir is not authorized for use in patients younger than 18 years of age, as it may affect bone and cartilage It is also not recommended for use during pregnancy, as there is a risk of fetal harm.
- In addition, the FDA stresses that molnupiravir is not authorized for pre- or post-exposure prevention of COVID-19 and is not a substitute for vaccination to protect against COVID-19.
- Recommended dosing is four 200mg capsules taken by mouth every 12 hours for five days. The drug is not authorized for use for longer than five days. The EUA fact sheet recommends that treatment be initiated as soon as possible after a COVID-19 diagnosis and within five days of symptom onset.
- Molnupiravir is an investigational antiviral medication that works by introducing errors into SARS- CoV-2’s genetic code that prevent the virus from replicating.