A long-acting agent with no known drug-drug interactions and a proven safety and tolerability profile

Minimal drug-drug interactions with CYP450 enzymes1

  • There is minimal potential for drug-drug interactions between DALVANCE and cytochrome P450 (CYP450) substrates, inhibitors, or inducers. No clinical drug-drug interaction studies have been conducted with DALVANCE

Low incidence of infusion-related reactions1

  • Flushing, phlebitis, and infusion-related reactions were reported infrequently, occurring in <2% of patients

No interaction with routinely used anticoagulant tests1

  • DALVANCE at therapeutic levels does not artificially prolong prothrombin time (PT) or activated partial thromboplastin time (aPTT)

The safety profile of DALVANCE was evaluated across 8 Phase 2 and Phase 3 trials1

Selected Adverse Reactions in ≥2% of Patients in the Phase 2/3 Trials*1

  DALVANCE
(N=1,778)
COMPARATORS
(N=1,224)
Nausea 5.5% 6.4%
Vomiting 2.8% 3.0%
Diarrhea 4.4% 5.9%
Headache 4.7% 4.8%
Rash 2.7% 2.4%
Pruritus 2.1% 3.3%

A causal relationship between study drug and adverse reactions was not always established.

Comparators included linezolid, cefazolin, cephalexin, and vancomycin.

Selected Adverse Reactions in ≥2% of Patients in 1 Dose Clinical Trial*1,2

  DALVANCE 1 DOSE
(N=349)
DALVANCE 2 DOSE
(N=346)
Nausea 3.4% 2%
  • Clostridium difficile colitis was reported in 0.2% of patients receiving DALVANCE in clinical trials5

Adverse Reactions

  • The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%)
  • Serious adverse reactions occurred in 121/2473 (4.9%) of patients treated with any regimen of DALVANCE. In the Phase 2/3 trials comparing DALVANCE to comparator, serious adverse reactions occurred in 109/1778 (6.1%) of patients in the DALVANCE group and 80/1224 (6.5%) of patients in the comparator group. In a Phase 3 trial comparing DALVANCE single-dose and two-dose regimens, serious adverse reactions occurred in 7/349 (2.0%) of patients in the DALVANCE single-dose group and 5/346 (1.4%) of patients in the DALVANCE two-dose group
  • DALVANCE was discontinued due to an adverse reaction in 64/2473 (2.6%) patients treated with any regimen of DALVANCE. In the Phase 2/3 trials comparing DALVANCE to comparator, DALVANCE was discontinued due to an adverse reaction in 53/1778 (3.0%) of patients in the DALVANCE group and 35/1224 (2.9%) of patients in the comparator group. In a Phase 3 trial comparing DALVANCE single-dose and two-dose regimens, DALVANCE was discontinued due to an adverse reaction in 6/349 (1.7%) of patients in the DALVANCE single-dose group and 5/346 (1.4%) of patients in the DALVANCE two-dose group

In the 1 dose DALVANCE trial

Median duration of treatment-emergent adverse events (TEAE) was only 3 days

Duration of TEAE in 1 dose clinical trial6

PERCENT OF TEAE BY DAYS OF DURATION IN 1 DOSE CLINICAL TRIAL6

  • The median duration of TEAE was 3.0 days in both treatment groups5

TEAE included nausea, headache, vomiting, diarrhea, dizziness, cellulitis, chills, and localized infection.

In the DISCOVER trials

2 dose DALVANCE duration of adverse reactions were similar to standard of care

Duration of adverse reactions in Phase 2/3 trials6

PERCENT OF ADVERSE REACTIONS BY DAYS OF DURATION IN PHASE 2/3 TRIALS6

  • The median duration of adverse reactions was 3.0 days for DALVANCE and 4.0 days for comparators6

Comparators included linezolid, cefazolin, cephalexin, and vancomycin.

Next: Ordering and Preparation

1 Dose Efficacy

DALVANCE is also available as a 1 dose, 30-minute infusion.

Select "Learn More" below to view the efficacy data of DALVANCE 1 dose.

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.

Show More
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.