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Prescribing Information


CONTACT US

Phone Number 1-855-387-2824
   
Fax Number 1-855-888-7206

Monday through Friday
8 am to 8 pm ET
DalvanceConnects@lashgroup.com

The information provided in this site is intended for US healthcare professionals only.

Ø Reimbursement Support Services through DALVANCE CONNECTS includes

·         Benefit Verification

·         Billing and Coding Support

·         Prior Authorization Research and Support

·         Claims Tracking

·         Claim Denial Appeal Support

Ø Other Services include

·         Infusion Facility identification

·         Infusion Reminders

·         Patient Savings Program for commercially insured patients.

 

INDICATION AND 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, rash, and/or back pain.

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.