FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults 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 the FDA are not accessible or clinically appropriate. Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth. It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19.
Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. Therefore, molnupiravir is not recommended for use during pregnancy. Molnupiravir is only authorized to be prescribed to a pregnant individual after the prescribing healthcare provider has determined that the benefits of being treated with molnupiravir would outweigh the risks for that individual patient and after the prescribing health care provider has communicated the known and potential benefits and the potential risks of using molnupiravir during pregnancy to the pregnant individual. Females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for four days after the final dose. Males of reproductive potential who are sexually active with females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for at least three months after the final dose. Questions and concerns about reliable birth control methods that are appropriate for use during treatment with molnupiravir, as well as how molnupiravir may affect sperm cells, should be directed at one’s healthcare provider.
Under the EUA, fact sheets that provide important information about using molnupiravir in the treatment of COVID-19 as authorized must be made available to healthcare providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects and information about who is able to prescribe molnupiravir.
|
