Predictable PK/PD profile that remains above MIC level

DALVANCE Pharmacokinetic Parameters in Healthy Subjects1

PARAMETER Single 1000 mg Dose Single 1500 mg Dose
Cmax (mg/L) 287 (13.9)* 423 (13.2)
AUC0-24 (mg•h/L) 3185 (12.8)* 4837 (13.7)

All values are presented as mean (% coefficient of variation).
*Data from 50 healthy subjects.
Data from 12 healthy subjects.

  • In healthy subjects, DALVANCE AUC0-24h and Cmax both increased proportionally to dose following single IV DALVANCE doses ranging from 140 mg to 1500 mg, indicating linear pharmacokinetics1

Pharmacokinetic parameters after one 1000 mg dose1

  • Effective half-life is approximately 8.5 days
  • Terminal elimination half-life is 14.4 days

DALVANCE consistently stayed above the susceptibility breakpoint of 0.25 mcg/mL up until the 14.4-day terminal elimination half-life1

Susceptibility breakpoint for designated Gram-positive pathogens.

No apparent accumulation of DALVANCE was observed following multiple IV infusions administered once weekly for up to 8 weeks, with 1000 mg on Day 1 followed by up to 7 weekly 500 mg doses, in healthy adults with normal renal function.1

AUC=area under the curve;
MIC=minimum inhibitory concentration;
PK=pharmacokinetic;
PD=pharmacodynamic.

Next: 1 Dose DALVANCE

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.