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.
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.
Therapeutic effects:
Reduction in hospitalization or mortality.
Pharmacokinetics⬆⬇
Absorption: Well absorbed.
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
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.
Availability⬆⬇
Capsules: 200 mg
Assessment⬆⬇
Assess COVID-19 symptoms (fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea) during therapy.
Lab Test Considerations:
Verify negative pregnancy test before starting therapy.
Implementation⬆⬇
PO: Administer twice daily without regard to food for 5 days.
Administration via nasogastric (NG) or orogastric (OG) tube (≥12F), open four (4) capsules and transfer contents into a clean container with a lid. Add 40 mL of water to container. Put lid on container and shake to mix the capsule contents and water thoroughly for 3 minutes. Capsule contents may not dissolve completely; prepared mixture may have visible undissolved particulates and are acceptable for administration. Flush NG/OG tube with 5 mL of water before administration. Using a catheter tip syringe, draw up entire contents from container and administer immediately through the NG/OG tube. Do not keep mixture for future use. If any portion of capsule contents are left in container, add 10 mL of water to container, mix, and using the same syringe draw up entire contents of the container and administer through the NG/OG. Repeat as needed until no capsule contents are left in container or syringe. Flush NG/OG tube with 5 mL of water twice (10 mL total) after administration of mixture.
If patient requires hospitalization after starting therapy, patient may complete the full 5 day course per the health care professional's discretion.
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.
