Molnupiravir Information

What is this drug used for?

• It is used to treat COVID-19 in those infected by SARS-CoV-2.

Adverse Effects

1-10%

• Diarrhea (2%)
• Nausea (1%)
• Dizziness (1%)

≤2%

• Selected Grade 3 and 4 laboratory abnormalities in chemistry (ALT, AST, creatinine, and lipase) and hematology (hemoglobin, platelets, and leukocytes)

Cautions

• There are limited clinical data available; serious and unexpected adverse events may occur that have yet to be reported.
• May cause fetal harm when administered to pregnant females.

Bone and cartilage toxicity

• Not authorised for use in patients aged <18 years owing to possible effects on bone and cartilage growth
• Bone and cartilage toxicity was observed in rats after repeated dosing
• Safety and efficacy have not been established in pediatric patients

Pregnancy

• Not recommended during pregnancy

Dosage Modifications

Renal impairment

• Mild or moderate (eGFR >30 mL/min): No dosage adjustment necessary
• Severe (eGFR <30 mL/min), end-stage renal disease, or patients on dialysis: Pharmacokinetics not evaluated; not expected to have a significant effect on NHC (N4-hydroxycytidine) exposure

Hepatic impairment

• Mild to severe (Child-Pugh Class A to C): No dosage adjustment required
• Preclinical data indicate that hepatic elimination is not expected to be a major route of NHC elimination

Dosing Considerations

Verify pregnancy status in females of childbearing potential before initiating

Limitations of use

• Not authorised for use in patients aged <18 years
• Not authorised for initiation of treatment in patients requiring hospitalization owing to COVID-19
• Not authorised for use for >5 consecutive days
• Not authorised for preexposure or postexposure prophylaxis for prevention of COVID-19

Administration