Adverse reactions1

Serious adverse reactions and adverse reactions leading to discontinuation
Adverse reaction Fetrojaa
(n=300)
Imipenem/
cilastatinb
(n=148)
Serious adverse reactions 4.7% 8.1%
Death 0.3% 0%
Discontinuation of treatment due to adverse reaction 1.7% 2.0%
In patients who received Fetroja, discontinuation of treatment due to adverse reaction included diarrhea (0.3%), drug hypersensitivity (0.3%), and increased hepatic enzymes (0.3%).
Selected adverse reactions occurring in ≥2% of patients receiving Fetroja in the cUTI trial
Diarrhea 4% 6%
Infusion site reactionsc 4% 5%
Constipation 3% 4%
Rashd 3% <1%
Candidiasise 2% 3%
Cough 2% <1%
Elevations in liver testsf 2% <1%
Headache 2% 5%
Hypokalemiag 2% 3%
Nausea 2% 4%
Vomiting 2% 1%
Swipe table for more
a 2 grams IV over 1 hour every 8 hours (with dosing adjustment based on renal function).
b 1 gram IV over 1 hour every 8 hours (with dosing adjustment based on renal function and body weight).
c Infusion site reactions include infusion site erythema, inflammation, pain, pruritus, injection site pain, and phlebitis.
d Rash includes rash macular, rash maculopapular, erythema, skin irritation.
e Candidiasis includes oral or vulvovaginal candidiasis, candiduria.
f Elevations in liver tests include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, blood alkaline phosphatase, hepatic enzyme increased.
g Hypokalemia includes blood potassium decreased.