INDICATION & USAGE:
BAXDELA is a fluoroquinolone antibacterial indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be used only to treat ABSSSI that are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION:
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, and EXACERBATION OF MYASTHENIA GRAVIS
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including:
- Tendinitis and tendon rupture
- Peripheral neuropathy
- Central nervous system effects
Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions.
Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid BAXDELA in patients with known history of myasthenia gravis.
BAXDELA is contraindicated in patients with known hypersensitivity to BAXDELA or other fluoroquinolones.
Warnings and Precautions
Risk of tendinitis, tendon rupture, peripheral neuropathy, and central nervous system effects is increased with use of fluoroquinolones. Discontinue BAXDELA immediately at the first signs or symptoms of any of these serious adverse reactions.
Avoid BAXDELA in patients with known history of myasthenia gravis.
Hypersensitivity reactions may occur after first or subsequent doses of BAXDELA. Discontinue BAXDELA at the first sign of hypersensitivity.
Clostridium difficile-associated diarrhea has been reported in users of nearly all systemic antibacterial drugs, including BAXDELA. Evaluate if diarrhea occurs.
Prescribing BAXDELA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse ReactionsThe most common adverse reactions in patients treated with BAXDELA were nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%), and vomiting (2%).
Use in Specific Populations
In patients with severe renal impairment (eGFR of 15-29 mL/min/1.73 m2), the dosage of BAXDELA should be decreased to 200 mg IV every 12 hours or 450 mg orally every 12 hours. BAXDELA is not recommended in patients with End Stage Renal Disease [ESRD] (eGFR of <15 mL/min/1.73 m2) due to insufficient information to provide dosing recommendations.
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 U.S Food and Drug Administration at 1-888-INFO-FDA (1-888-463-6332)
©2017 All rights reserved PP-BAX-US-0072 v1.0