Dalvance (dalbavancin) Side Effects, Cost, Mechanism, Prescribing Information for ABSSSI | Sahar Anjomshoaa, PharmD | RxEconsult
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Dalvance (dalbavancin) Side Effects, Cost, Mechanism, Prescribing Information for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Category: Bacterial Infections by - October 21, 2014 | Views: 24269 | Likes: 1 | Comment: 0  

Dalvance for ABSSI

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:        

  • Trial 1; Dalvance group (83.3%) versus vancomycin/linezolid (81.8%)
  • Trial 2; Dalvance group (76.8%) versus vancomycin/linezolid (78.3%)

Patients in ABSSSI trials with reduction in lesion area of 20% or greater at 48 to 72 hours after initiation of therapy:

  • Trial 1; Dalvance group (89.9%) and vancomycin/linezolid (90.9%)
  • Trial 2; Dalvance group (87.6%) and vancomycin/linezolid (85.9%)

Clinical success rates in ABSSSI trials at follow-up (Day 26 to 30)

  • Trial 1; Dalvance group (83.7%) and vancomycin/linezolid (88.1%)
  • Trial 2; Dalvance group (88.1%) and vancomycin/linezolid (84.5%)

Interesting Facts about Dalvance

  • Dalvance is the first IV antibiotic approved for treatment of ABSSSI with once a week dosing for a treatment duration of two weeks.
  • Dalvance does not require monitoring of blood levels to determine the most effective dose. 
  • It is produced from a fermentation product of bacteria. 

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?

  • Hypersensitivity Reactions: Serious skin and hypersensitivity (anaphylaxis) reactions may occur. If allergic reactions occur, Dalvance should be discontinued.
  • Infusion Related Reactions: Rapid infusion can cause serious reactions called “Red-Man Syndrome” that includes flushing of upper body, itching, and rash.
  • Clostridium difficile associated diarrhea: If severe diarrhea occurs, Dalvance should be discontinued and diarrhea should be managed quickly. 
  • Development of Drug Resistant Bacteria: Dalvance shouldn’t be prescribed if strong bacterial infection is not suspected due to an increase risk of drug-resistance.  

Use of Dalvance in special populations

  • Pregnancy: Category C
  • Nursing Mothers: It is unknown if Dalvance is excreted in milk therefore, caution should be advised in administering it in nursing mothers
  • Pediatric Use: There is no data in safety and efficacy use of Dalvance in pediatrics
  • Geriatric Use: Elderly patients are more likely to have a decrease renal function and since Dalvance excreted by kidney caution is advised.
  • Renal Impairment: For patients receiving hemodialysis dosage adjustment is not needed. If patients are not receiving hemodialysis, dosage adjustment is necessary.  
  • Hepatic Impairment: No dosage adjustment needed for mild hepatic impairment but caution is advised in moderate to severe hepatic impairment patients. No data available on appropriate dosing.

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.

References

Dalvance, Prescribing Information, Durata Therapeutics U.S., May 2014

REDBOOK Online, Truven Health Analytics, Inc.;2014

Also Read: New Antibiotics Vibativ, Dalvance, Orbactiv, and Sivextro for Acute Bacterial Skin Infection (ABSSSI)


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