What is this drug used for?
- It is used to treat COVID-19 in those infected by SARS-CoV-2.
- Diarrhea (2%)
- Nausea (1%)
- Dizziness (1%)
- Selected Grade 3 and 4 laboratory abnormalities in chemistry (ALT, AST, creatinine, and lipase) and hematology (hemoglobin, platelets, and leukocytes)
- 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
- Not recommended during pregnancy
- 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
- 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
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
Take orally, with or without food
- <10 hours: Take missed dose as soon as possible, and resume normal dosing schedule
- >10 hours: Skip dose, and take the next dose at the regularly scheduled time
- Do not double dose to make up for missed dose
Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)