BAXDELA™ is well tolerated
The most common side effects were nausea and diarrhea and were generally mild/moderate, of limited duration, and did not lead to discontinuation of drug
aThe data are not an adequate basis for comparison of rates between the study drug and the active control.
bPooled reports include hypertransaminasaemia, increased transaminases, and increased ALT and AST.
Discontinuation rate is not statistically significant.
QT prolongation was not observed in patients taking BAXDELA in a definitive QT study
Photosensitivity was not observed in patients taking BAXDELA in a photosafety study
aHy's law is a rule of thumb that a patient is at high risk of a fatal drug-induced liver injury if given a medication that causes hepatocellular injury with jaundice.
Melinta Therapeutics, Inc. - The Antibiotics Company
For additional information about BAXDELA, call Melinta Therapeutics at 1-844-MELINTA (1-844-635-4682) or contact the US Food and Drug Administration at 1-888-INFO-FDA (1-888-463-6332).