Mild-to-moderate COVID-19 infection in non-hospitalized patients 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 FDA are not accessible or clinically appropriate.
An Emergency Use Authorization (EUA) has been issued for this use of molnupiravir; this drug is not FDA-approved for the above indication.
Contraind./Precautions⬆⬇
Contraindicated in:
Pedi: Children <18 yr (may affect bone and cartilage growth);
Lactation: Lactation.
Use Cautiously in:
Rep: Women and men of reproductive potential;
OB: Use during pregnancy only if the potential maternal benefit outweighs potential fetal risk (has caused fetal harm in animal studies).
PO (Adults ): 800 mg every 12 hr for 5 days. Should be started as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
US Brand Names⬆⬇
Lagevrio
Action⬆⬇
As a prodrug, molnupiravir is metabolized to the active cytidine nucleoside analogue, NHC, which distributes into cells where NHC is phosphorylated to the active ribonucleoside triphosphate (NHC-TP). NHC-TP is incorporated as NHC-monophosphate into SARS-CoV-2 RNA by the viral RNA polymerase which results in inhibition of viral RNA replication.
Distribution: Widely distributed to extravascular tissues.
Metabolism/Excretion: Molnupiravir is a prodrug that is metabolized intracellularly to the active metabolite, NHC-TP. 3% excreted in urine.
Half-Life: 3.3 hr.
Time/Action Profile⬆⬇
(plasma concentrations)
ROUTE
ONSET
PEAK
DURATION
PO
unknown
1.5 hr
12 hr
Patient/Family Teaching⬆⬇
Instruct patient to take molnupiravir as directed for full course of therapy. If dose is missed within 10 hr of usual time take it as soon as possible and resume normal dosing schedule. If dose is missed by >10 hours, omit dose and take next dose at the regularly scheduled time. Do not double dose to make up for a missed dose.
Advise patient to discontinue therapy and notify health care professional promptly at first sign of hypersensitivity reaction (skin rash, hives or other skin reactions, rapid heartbeat, difficulty swallowing or breathing, swelling of the lips, tongue, face, tightness of the throat, hoarseness).
Advise patient to continue isolation in accordance with public health recommendations to maximize viral clearance and minimize transmission of SARS-CoV-2.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during therapy and avoid breastfeeding during and for 4 days after last dose. Advise males with female partners of reproductive potential to use effective contraception during and for 3 months after last dose. If patient decides to take molnupiravir during pregnancy, prescribing health care professional must document that the known and potential benefits and potential risks of using molnupiravir during pregnancy were communicated to the pregnant individual. Pregnancy registry monitors pregnancy outcomes in individuals exposed to molnupiravir during pregnancy. Encourage patient to enroll in pregnancy registry at https://covid-pr.pregistry.com or 1-800-616-3791.
