Mandatory requirements for administration of molnupiravir under emergency use authorization.

In order to mitigate the risks of using this unapproved product under the EUA and to optimize the potential benefit of molnupiravir, the following steps are required. Use of molnupiravir under this EUA is limited to the following (all requirements must be met):

1. Treatment of mild-to-moderate COVID-19 in adults with a positive result of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate [see LIMITATIONS OF AUTHORIZED USE (1)].
2. As the prescribing healthcare provider, review the information contained within the “Fact Sheet for Patients and Caregivers” with your patient or caregiver prior to the patient receiving molnupiravir. Healthcare providers must provide the patient/caregiver with an electronic or hard copy of the “Fact Sheet for Patients and Caregivers” prior to the patient receiving molnupiravir and must document that the patient/caregiver has been given an electronic or hard copy of the “Fact Sheet for Patients and Caregivers”.
3. The prescribing healthcare providers must inform the patient/caregiver that:
   1. Molnupiravir is an unapproved drug that is authorized for use under this Emergency Use Authorization.
   2. Other therapeutics are currently approved or authorized for the same use as molnupiravir. [see EMERGENCY USE AUTHORIZATION (1) - INFORMATION REGARDING AVAILABLE ALTERNATIVES FOR THE EUA AUTHORIZED USE].
   3. There are benefits and risks of taking molnupiravir as outlined in the “Fact Sheet for Patients and Caregivers.”
   4. Merck Sharp & Dohme has established a pregnancy surveillance program.
   5. Females of childbearing potential should use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for 4 days after the last dose of molnupiravir.
   6. Males of reproductive potential who are sexually active with females of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose.
4. The prescribing healthcare provider must assess whether a female of childbearing potential is pregnant or not, if clinically indicated [see WARNINGS AND PRECAUTIONS (5.1) and USE IN SPECIFIC POPULATIONS (8.3)].
5. Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. If molnupiravir is used during pregnancy, prescribing healthcare providers must communicate to the patient the known and potential benefits and the potential risks of molnupiravir use during pregnancy, as outlined in the “Fact Sheet for Patients and Caregivers” [see WARNINGS AND PRECAUTIONS (5.1, 5.3), USE IN SPECIFIC POPULATIONS (8.1, 8.3) and NONCLINICAL TOXICOLOGY (13.1)].
6. If the decision is made to use molnupiravir during pregnancy, the prescriber must document that the known and potential benefits and the potential risks of molnupiravir use during pregnancy, as outlined in the “Fact Sheet for Patients and Caregivers,” were discussed with the patient.
7. The prescribing healthcare provider must document that a pregnant individual was made aware of Merck Sharp & Dohme’s pregnancy surveillance program at 1-877-888-4231 or pregnancyreporting.msd.com.
   1. If the pregnant individual agrees to participate in the pregnancy surveillance program and allows the prescribing healthcare provider to disclose patient specific information to Merck Sharp & Dohme, the prescribing healthcare provider must provide the patient’s name and contact information to Merck Sharp & Dohme.
8. The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all medication errors and serious adverse events potentially related to molnupiravir within 7 calendar days from the healthcare provider’s awareness of the event [see ADVERSE REACTIONS (6.4)].

For information on clinical studies of molnupiravir and other therapies for the treatment of COVID-19, see WWW.CLINICALTRIALS.GOV.