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Indication for DALVANCE (dalbavancin) for injection
DALVANCE™ (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus).
Important Safety Information for DALVANCE (dalbavancin) for injection
DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.
WARNINGS and PRECAUTIONS
Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE; exercise caution in patients with known hypersensitivity to glycopeptides.
Rapid intravenous infusion of glycopeptide antibacterial agents can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.
ALT elevations with DALVANCE treatment were reported in clinical trials.
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE. Evaluate if diarrhea occurs.
The most common adverse reactions in patients treated with DALVANCE were nausea (5.5%), headache (4.7%), and diarrhea (4.4%).
USE IN SPECIFIC POPULATIONS
In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended two-dose regimen for DALVANCE is 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis.