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 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:
i. Molnupiravir is an unapproved drug that is authorized for use under this
Emergency Use Authorization.
ii. There are no adequate, approved, available products for the treatment of
COVID-19 in adults who have mild-to-moderate COVID-19 and are at high
risk for progressing to severe COVID-19, including hospitalization or death.
iii. Other therapeutics are currently authorized for the same use as molnupiravir.
For additional information on all products authorized for treatment or
prevention of COVID-19, please see
Page Not Found | FDA.
iv. There are benefits and risks of taking molnupiravir as outlined in the “Fact
Sheet for Patients and Caregivers.”
v. Merck Sharp & Dohme has established a pregnancy surveillance program.
vi. 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.
vii. 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, 5.2), 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.
a. 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)].