Mild to moderate COVID-19 infection in nonhospitalized patients with positive results of direct 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.
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, dyspnea, wheezing, 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. DNC: Do not open, break, or crush capsules. Start as soon as possible after COVID-19 diagnosis and within 5 days of symptom onset.
Administration via nasogastric (NG) or orogastric (OG) tube (≥12F): Open four 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 min. 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 provider's discretion.
Patient/Family Teaching⬆⬇
Explain the purpose and side effects of the medication to the patient. Instruct patient to take 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 hr, 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 read Patient Information before starting therapy.
Advise patient to discontinue therapy and notify health care provider 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, or 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 women of reproductive potential to use effective contraception during therapy and avoid breastfeeding during therapy and for 4 days after last dose. Advise men with female partners of reproductive potential to use effective contraception during therapy and for 3 mo after last dose. If patient decides to take molnupiravir during pregnancy, prescribing health care provider must document that the known and potential benefits and risks of using molnupiravir during pregnancy were communicated to the pregnant individual. Encourage patient to enroll in pregnancy registry that monitors outcomes by visiting https://covid-pr.pregistry.com or calling 1-800-616-3791.
Evaluation/Desired Outcomes⬆⬇
Reduction in hospitalization or mortality.
US Brand Names⬆⬇
Lagevrio
Code⬆
NDC Code
0006- Merck Sharp & Dohme LLC
0006-5055- LAGEVRIO
0006-5055-06- 40 CAPSULE in 1 BOTTLE, PLASTIC (0006-5055-06)
0006- Merck Sharp & Dohme LLC
0006-5055- LAGEVRIO
0006-5055-07- 40 CAPSULE in 1 BOTTLE, PLASTIC (0006-5055-07)
0006- Merck Sharp & Dohme LLC
0006-5055- LAGEVRIO
0006-5055-09- 40 CAPSULE in 1 BOTTLE, PLASTIC (0006-5055-09)
