Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 6.1 Adverse Reactions from Clinical Studies The following adverse reactions have been observed in the clinical study of LAGEVRIO that supported the EUA.
The adverse reaction rates observed in these clinical trials cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Additional adverse events associated with LAGEVRIO may become apparent with more widespread use.
Overall, more than 900 subjects have been exposed to LAGEVRIO 800 mg twice daily in clinical trials.
The safety assessment of LAGEVRIO is primarily based on an analysis from subjects followed through Day 29 in the Phase 3 study in non-hospitalized subjects with COVID-19 (MOVe-OUT) [see Clinical Studies (14) ] .
The safety of LAGEVRIO was evaluated based on an analysis of a Phase 3 double-blind trial (MOVe-OUT) in which 1,411 non-hospitalized subjects with COVID-19 were randomized and treated with LAGEVRIO (N=710) or placebo (N=701) for up to 5 days.
Adverse events were those reported while subjects were on study intervention or within 14 days of study intervention completion/discontinuation.
Discontinuation of study intervention due to an adverse event occurred in 1% of subjects receiving LAGEVRIO and 3% of subjects receiving placebo.
Serious adverse events occurred in 7% of subjects receiving LAGEVRIO and 10% receiving placebo;
most serious adverse events were COVID-19 related.
5 WARNINGS AND PRECAUTIONS There are limited clinical data available for LAGEVRIO.
Serious and unexpected adverse events may occur that have not been previously reported with LAGEVRIO use.
5.1 Embryo-Fetal Toxicity Based on findings from animal reproduction studies, LAGEVRIO may cause fetal harm when administered to pregnant individuals.
There are no available human data on the use of LAGEVRIO in pregnant individuals to evaluate the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes;
therefore, LAGEVRIO is not recommended for use during pregnancy.
Like all medications, Lagevrio can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: