DALVANCE is available as a 1 dose or as a 2 dose regimen

  • 1 dose: 1500 mg* 30-minute infusion
  • 2 dose: 1000 mg* followed 1 week later by 500 mg, each infused over 30 minutes

Vial shown not actual size.

*Dose adjustment is required in patients with CrCl<30 mL/min. See Use in Specific Populations below

Ordering Information
NDC Number 57970-100-01
Package configuration One 500 mg vial per carton
Package size 1 3/4" (w) x 3 5/8” (h) x 1 3/4” (d)

DALVANCE is supplied in single-use, clear glass vials containing sterile powder (white/off-white to pale yellow) equivalent to 500 mg of anhydrous dalbavancin.

Preparation1

Reconstitution

Each 500 mg vial of DALVANCE for injection must be reconstituted with either 25 mL of Sterile Water for Injection, USP, or 5% Dextrose Injection, USP.

Using a syringe, draw out the 25 mL of Sterile Water for Injection, USP, or 5% Dextrose Injection, USP.

Using a suitable gauge needle and syringe, each 500 mg vial of DALVANCE should be reconstituted by slowly adding 25 mL of Sterile Water for Injection, USP, or 5% Dextrose Injection, USP.

Gently roll the vial to ensure all surfaces containing DALVANCE have been wetted.

Alternate brief, gentle swirling with inversion of the vial to completely dissolve the DALVANCE.

To avoid excessive foaming, DO NOT shake the vial.

Visually inspect the vial to ensure that DALVANCE has completely dissolved prior to proceeding to dilution with 5% Dextrose for Injection, USP.

The reconstituted vial should contain 20 mg/mL of DALVANCE as a clear, colorless to yellow solution.

Dilution

Prior to administration, the reconstituted vial(s) of DALVANCE must be further diluted into a bottle or bag containing 5% Dextrose for Injection, USP.

Using appropriate aseptic technique, add the required volume of reconstituted DALVANCE to the 5% Dextrose for Injection, USP bag or bottle.

Storage of Reconstituted or Diluted DALVANCE1

Does not require refrigeration.

Once reconstituted or diluted into an intravenous bag or bottle as previously described, DALVANCE may be stored in a refrigerator between 2 to 8°C (36 to 46°F), or at controlled room temperature 20 to 25°C (68 to 77°F) for up to 48 hours.

Do not freeze.

Please see Full Prescribing Information for complete information on Preparation, Administration, and Storage.

The compatibility of reconstituted DALVANCE with intravenous medications, additives, or substances other than 5% Dextrose for Injection, USP, has not been established. Do not co-infuse DALVANCE with other medications or electrolytes.

Next: Reimbursement

Reimbursement

The permanent J-code for DALVANCE helps simplify claims processing. Facilitate payment while eliminating the need to use a miscellaneous code.

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.