In the DISCOVER trials

2 dose DALVANCE® provided early clinical response rates and proven clinical success at follow-up similar to standard of care

Early clinical response rates at 48 to 72 hours similar to standard of care3

DISCOVER Program pooled analysis of ITT population at 48 to 72 hours3

Primary endpoint: Cessation of lesion spread and absence of fever*

Key secondary endpoint: ≥20% reduction in lesion area

  • DALVANCE was shown to be noninferior to vancomycin/linezolid in these trials for the treatment of ABSSSI

Primary endpoint1,3: Clinical response rate, where responders were defined as patients who had no increase from baseline in lesion area 48 to 72 hours after initiation of therapy, and had a temperature consistently at or below 37.6°C upon repeated measurement.

Secondary endpoint1: This key secondary endpoint evaluated the percentage of ITT patients achieving a 20% or greater reduction in lesion area from baseline at 48 to 72 hours after initiation of therapy.

Clinical success rates at Days 26 to 303

Pooled analysis in the ITT population

Decrease in Lesion Size, Stable Temperature, Absent or Mild and Improved Local Signs

Comparisons of clinical success at follow-up cannot be used to establish noninferiority.§

Secondary endpoint3: Another secondary endpoint was the clinical success rate assessed at a follow-up visit occurring between Days 26 and 30. Clinical success at this visit was defined as having a decrease in lesion size (both length and width measurements), a temperature of 37.6°C or lower, and meeting prespecified criteria for local signs: purulent discharge and drainage absent or mild and improved from baseline, heat/warmth and fluctuance absent, swelling/induration and tenderness to palpation absent or mild.

There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at the follow-up visit.

DALVANCE was also studied in ABSSSI patients with baseline bacteremia1

  • In ABSSSI patients with baseline bacteremia, 85% (34/40) were clinical responders at 48 to 72 hours and 80% (32/40) were clinical successes at Day 26 to 301

In the 1 dose trial and DISCOVER trials, all patients had blood cultures obtained at baseline. A total of 40 ABSSSI patients who received DALVANCE had bacteremia at baseline caused by 1 or more of the following bacteria: S. aureus (n=26 [21 MSSA; 5 MRSA]), S. agalactiae (n=6), S. pyogenes (n=7), S. anginosus group (n=2), and E. faecalis (n=1).1

Next: Dosage & Administration

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INDICATION & USAGE

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, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin-susceptible strains).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT SAFETY INFORMATION
Contraindications

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

Warnings and Precautions

Hypersensitivity Reactions

Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DALVANCE should be discontinued.

Infusion-related Reactions

Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.

Hepatic Effects

ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

Development of Drug-resistant Bacteria

Prescribing DALVANCE 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 Reactions

The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%).

Use in Specific Populations

Please see Full Prescribing Information.

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IMPORTANT SAFETY INFORMATION
Contraindications

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

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Warnings and Precautions

Hypersensitivity Reactions

Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DALVANCE should be discontinued.

Infusion-related Reactions

Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.

Hepatic Effects

ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

Development of Drug-resistant Bacteria

Prescribing DALVANCE 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 Reactions

The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%).

Use in Specific Populations
  • There have been no adequate and well-controlled studies with DALVANCE in pregnant or nursing women. DALVANCE should only be used if the potential benefit justifies the potential risk in these 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 regimen of DALVANCE is 1125 mg, administered as a single dose, or 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.
  • Caution should be exercised when prescribing DALVANCE to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients.

Please see Full Prescribing Information.