Safety & Tolerability

Straightforward Treatment in Patients
With Complications

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

Most Common Treatment-Emergent Adverse Events (TEAEs) Occurred in ≥2.0% (pooled data from phase 3 trials)

BAXDELA
N=741
Vancomycin
+ aztreonam
N=751
Nausea 8% 6%
Diarrhea 8% 3%
Headachea 3% 6%
Transaminase elevationsa 3% 4%
Vomiting 2% 2%
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.

Discontinuations Due to Treatment-Related Adverse Events (n/N)

BAXDELA Vancomycin + aztreonam
BAXDELA discontinuations chart due to treatment-related adverse events

Discontinuation rate is not statistically significant.

Important Additional Safety Information

QT prolongation was not observed in patients taking BAXDELA in a definitive QT study

  • Some fluoroquinolones have been associated with prolongation of the QT interval on electrocardiogram and infrequent cases of arrhythmia
  • A thorough QT study found no QT prolongation in patients taking BAXDELA compared with moxifloxacin

Photosensitivity was not observed in patients taking BAXDELA in a photosafety study

  • Fluoroquinolones have been associated with the potential for phototoxicity; however, a phase 1 study conducted in 52 healthy volunteers demonstrated no clinically relevant photosensitizing potential for BAXDELA compared with lomefloxacin
  • Potential for phototoxic reactions should always be considered when caring for patients taking BAXDELA or any other marketed fluoroquinolone

Hepatotoxicity

  • Postmarketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with fluoroquinolones
  • No cases of Hy’s lawa were reported in the BAXDELA clinical trials

Dysglycemia

  • Dysglycemia, including hypoglycemia, has been associated with all fluoroquinolones, which are believed to stimulate insulin release via interference with the K+/ATPase pump in pancreatic β cells
  • In phase 3 trials, the incidence of dysglycemia was similar to the incidence observed with vancomycin plus aztreonam

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.