Dalbavancin

1 INDICATION AND USAGE DALVANCE is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial drugs, DALVANCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Dalbavancin is an antibacterial drug.

Dosage in Adult Patients: Estimated Creatinine Clearance ( C L cr) Single Dose Regimen Two-D ose Regimen 30 mL/min and above or on regular hemodialysis 1,500 mg 1,000 mg followed one week later by 500 mg Less than 30 mL/min and not on regular hemodialysis 1,125 mg 750 mg followed one week later by 375 mg Administer by intravenous infusion over 30 minutes. See Full Prescribing Information for instructions on reconstitution of lyophilized powder and preparation of injection. Dosage in Pediatric Patients with CLcr 30 mL/min/1.73m 2 and above. Age Range Dosage (Single Dose Regimen) Birth to less than 6 years 22.5 mg/kg (maximum of 1,500 mg) 6 to less than 18 years 18 mg/kg (maximum of 1,500 mg) Dosage adjustment in pediatric patients with CLcr less than 30 mL/min has not been studied.

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin. Known hypersensitivity to dalbavancin

Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with DALVANCE. If an allergic reaction occurs, discontinue treatment with DALVANCE and institute appropriate therapy for the allergic reaction. Carefully monitor patients with known hypersensitivity to glycopeptides. Rapid intravenous infusion of DALVANCE can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessation of these reactions. Alanine Aminotransferase (ALT) elevations with DALVANCE treatment were reported in clinical trials. Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE. Evaluate if diarrhea occurs.

The following clinically significant adverse reactions are also discussed elsewhere in the labeling: Hypersensitivity Reactions Infusion Related Reactions Hepatic Effects Clostridioides difficile -associated Diarrhea The most common adverse reactions occurring in >4% of adult patients treated with DALVANCE were nausea, headache, and diarrhea. The most common adverse reaction that occurred in >1% of pediatric patients was pyrexia.

Drug-Laboratory Test Interactions Drug-laboratory test interactions have not been reported. DALVANCE at therapeutic concentrations does not artificially prolong prothrombin time (PT) or activated partial thromboplastin time (aPTT).

Storage of the reconstituted and diluted solutions of DALVANCE are described elsewhere in the prescribing information.