REMDESIVIR INJ,SOLN
Clinical Criteria Summary
Indication & Patient Population
- Emergency Use Authorization (EUA) for patients 18 years and older
- Mild-to-moderate COVID-19 at high risk for progression
- Use only if other alternatives are not accessible or clinically appropriate
Dosing & Administration
- 800 mg (4 capsules) twice daily for 5 days
- Can be administered with or without food
Contraindications & Warnings
- No contraindications listed
- Possible embryo-fetal toxicity
- Possible bone/cartilage toxicity in patients <18 years old
Adverse Reactions & Efficacy
- Adverse reactions: diarrhea, nausea, dizziness
- MOVe-OUT trial data: Death or hospitalization by day 29 was 6.8% (MOV) vs. 9.7% (placebo)
Special Populations & Precautions
- Not recommended in pregnancy and lactation due to potential embryo-fetal toxicity based on animal data
- If used, requires extensive discussion/documentation
- Requires reliable, consistent contraception during therapy and for 4 days after last dose in females of childbearing potential
- Requires reliable, consistent contraception for 3 months after last dose in males of reproductive potential
Renal/Hepatic Considerations
- No dose adjustment required for renal or hepatic dysfunction