Brand Name: Dalvance
Generic Name: Dalbavancin
Medication Class: Glycopeptides, Lipoglycopeptides
Similar Drug: Vibativ (telavancin), Cubicin (daptomycin), Vancocin (vancomycin), Orbactiv (oritavancin),
Manufacturer: Durata Therapeutics
FDA Approval Date: May 2014
What is Dalvance and its mechanism of action?
Dalvance is a synthetic lipoglycopeptide antibiotic synthesized from a fermentation product of bacteria classified as Nonomuraea species. Lipoglycopeptide antibiotics have a lipophilic side chain that is linked to glycopeptides. Bacteria have cell walls that are made of peptidoglycan. In an event of infection, bacteria rapidly grow and they need cell walls to survive. Antibiotics such as Dalvance kill bacteria by inhibiting cell wall synthesis and preventing cross-linking of peptidoglycan. This causes the cell wall to weaken and kills susceptible bacteria.
What is Dalvance used for treating?
Dalvance is used for treating acute bacterial skin and skin structure infections (ABSSSI) caused by gram-positive bacteria such as Staphylococcus aureus (including methicillin susceptible and methicilliln-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group (including S. anginosus, S. intermedius, S.constellatus).
How effective is Dalvance?
The safety and efficacy of Dalvance was analyzed in 2 randomized, double-blind, double-dummy clinical trials of similar design (Trial 1 and Trial 2). There were 1,312 patients enrolled with acute bacterial skin and skin structure infections (ABSSSI). These patients received a two-dose regimen of intravenous Dalvance (1000 mg followed one week later by 500 mg) or intravenous vancomycin (1000 mg or 15 mg/kg every 12 hours, with the option to switch to oral linezolid after 3 days). Treatment duration was for two weeks.
Clinical response (no increase in lesion size and temperature below 37.6 degrees Celsius) rates in ABSSSI trials at 48 to 72 hours after the initiation of therapy:
Patients in ABSSSI trials with reduction in lesion area of 20% or greater at 48 to 72 hours after initiation of therapy:
Clinical success rates in ABSSSI trials at follow-up (Day 26 to 30)
Interesting Facts about Dalvance
What are side effects of Dalvance?
Common side effects of Dalvance are nausea, headache, diarrhea, vomiting, and rash.
What are warnings and precautions for Dalvance?
Use of Dalvance in special populations
What is the dosage of Dalvance and how is it administered?
Dalvance comes in single-use vial containing 500 mg of powder. It needs to be reconstituted with sterile water.
The recommended dose of Dalvance is two doses, 1000 mg initially then 500 mg one week later. It should be administered over 30 minutes by intravenous infusion.
What are Dalvance drug interactions?
There are no known significant drug-drug interaction between Dalvance and other medications.
What is the cost of Dalvance?
The wholesale price of one vial of Dalvance 500 mg is $1490.00 and the retail price is $1534.86.
How to obtain prescription cost assistance for Dalvance?
To receive patient assistance for Dalvance visit Dalvance Reimbursement.
Dalvance, Prescribing Information, Durata Therapeutics U.S., May 2014
REDBOOK Online, Truven Health Analytics, Inc.;2014