ABSSSI Safety & Tolerability
BAXDELA® (delafloxacin) Has a Demonstrated
Safety Profile in ABSSSI
Most Common Treatment-Emergent Adverse Events in ABSSSI Studies 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 elevationsb | 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) in ABSSSI Studies
Difference in discontinuation rate is not statistically significant.
Safety Observations from Clinical Studies
QT prolongation was not observed in patients taking BAXDELA in a QT study
- No evidence of QT prolongation was observed in patients taking BAXDELA 300 or 900 mg IV in a definitive QT study vs oral moxifloxacin 400 mg or placebo
Photosensitivity was not observed in patients taking BAXDELA in a photosafety study
- No clinically significant phototoxic potential was observed in BAXDELA 200 or 400 mg/day oral in a photosafety study vs lomefloxacin as the active comparator
No cases of Hy’s lawa were reported in the BAXDELA clinical trials1
The incidence of dysglycemia in the BAXDELA arm was similar to the incidence observed with vancomycin plus aztreonam in Phase 3 ABSSSI trials1
- Fluoroquinolones have been associated with disturbances of blood glucose. Severe cases of hypoglycemia resulting in coma or death have been reported with other fluoroquinolones. Monitor blood glucose carefully in diabetic patients receiving oral hypoglycemic agents or insulin. Discontinue BAXDELA and initiate appropriate therapy immediately if a hypoglycemic reaction occurs
Minimal potential for drug interactions demonstrated during development
- No drug-drug interactions due to CYP450
- Oral BAXDELA should be taken 2 hours before or 6 hours after antacids or multivitamins containing iron or zinc
- Do not administer any solution containing multivalent cations (eg, calcium and magnesium) through the same IV line
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions. Please refer to Important Safety Information.
1. Data on file. Melinta Therapeutics, LLC.
aHy's law is an indicator of a drug's potential to cause serious liver injury.
INDICATION & USAGE:
BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
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