Dalvance (dalbavancin HCl)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Dalbavancin hydrochloride, a lipoglycopeptide antibacterial, is a semisynthetic derivative of a naturally occurring glycopeptide.
Dalbavancin hydrochloride is a semisynthetic lipoglycopeptide antibacterial derived from a naturally occurring glycopeptide produced by Nonomuraea, an actinomycete. The drug is a teicoplanin-type lipoglycopeptide and contains a heptapeptide core structure that differs from that of vancomycin. Dalbavancin is a mixture of 5 closely related homologs (i.e., A0, A1, B0, B1, B2), each sharing the same core structure.
Of the 5 homologs, B0 is the major component of dalbavancin.
The mechanism of action of dalbavancin is similar to that of other glycopeptides (e.g., oritavancin, telavancin, vancomycin). Dalbavancin binds to the d-alanyl-d-alanine terminus of growing peptidoglycan chains, thereby inhibiting bacterial cell wall synthesis. The drug also appears to dimerize and anchor in the bacterial membranes.
In vitro, dalbavancin is bactericidal in action against certain gram-positive bacteria, including staphylococci, streptococci, and enterococci. The drug is active in vitro and in clinical infections against S. aureus (including methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant S. aureus or ORSA)), S. pyogenes (group A beta-hemolytic streptococci, GAS), S. agalactiae (group B streptococci, GBS), and S. anginosus group (includes S. anginosus, S. intermedius, and S. constellatus). Dalbavancin also is active in vitro against some vancomycin-susceptible Enterococcus faecium and E. faecalis; however, safety and efficacy of the drug in treating clinical infections caused by these bacteria have not been established.
Dalbavancin is active in vitro against some vancomycin-intermediate S. aureus (VISA) and VanB and VanC phenotypes of vancomycin-resistant enterococci (VRE), but VRE with the VanA phenotype have reduced in vitro susceptibility or resistance to dalbavancin.
Reduced susceptibility or resistance to dalbavancin was not produced in vitro by serial passage of S. aureus in the presence of increasing concentrations of the drug. Certain intrinsically glycopeptide-resistant bacteria and those expressing the VanA phenotype of acquired resistance to vancomycin also may be resistant to dalbavancin. Cross-resistance between dalbavancin and nonglycopeptide anti-infectives is unlikely.
Dalbavancin exhibits linear, dose-dependent pharmacokinetics following IV administration, and there is no apparent accumulation following multiple IV doses of the drug. In adults with skin and skin structure infections, a single 1-g IV dose of dalbavancin given on day 1 followed by a single 500-mg IV dose on day 8 resulted in mean plasma dalbavancin concentrations of 30 mg/L immediately before the second dose and mean plasma concentrations of 21 mg/mL (range 8-40 mg/L) 20 days after the initial dose. Dalbavancin is distributed into skin blister fluid following IV administration, and mean blister fluid concentrations are at least 30 mg/L for up to 7 days following a single 1-g IV dose.
The drug is approximately 93% bound to plasma proteins, mainly albumin. Dalbavancin is not a substrate, inhibitor, or inducer of cytochrome P-450 (CYP) isoenzymes; a minor metabolite, hydroxydalbavancin, has been detected in urine. Based on population pharmacokinetic analyses, the effective half-life of dalbavancin is approximately 8.5 days (204 hours).
Following a single 1-g dose of dalbavancin, 20% of a dose is eliminated in feces by day 70 after the dose. An average of 33% of the dose is eliminated in urine as unchanged drug and approximately 12% is eliminated in urine as the metabolite by day 42 after the dose. Less than 6% of an administered dose of dalbavancin is removed after 3 hours of hemodialysis.
USES: This medication is used to treat serious bacterial infections of the skin. It works by stopping the growth of bacteria.
Generic name: dalbavancin HCl
Pronunciation: (DAL-ba-VAN-sin)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Dalvance
Indications
The following indications are listed for Dalvance:
- Complicated Skin And Skin Structure Enterococcus Faecalis Infection
- Complicated Skin And Skin Structure Infection
- Complicated Skin And Skin Structure Staphylococcus Aureus Infection
- Complicated Skin And Skin Structure Streptococcus Agalactiae Infection
- Complicated Skin And Skin Structure Streptococcus Dysgalactiae Infection
- Complicated Skin And Skin Structure Streptococcus Pyogenes Infection
- Skin And Skin Structure Streptococcus Infection
Also known as: Complicated Bacterial Skin And Skin Structure Infection, Complicated Skin And Skin Soft Tissue Enterococcus Faecalis Infection, Complicated Skin And Skin Soft Tissue Infection, Complicated Skin And Skin Soft Tissue Infection Due To Streptococcus Pyogenes, Complicated Skin And Skin Structure Bacterial Infection, Complicated Staphylococcus Aureus Skin And Skin Soft Tissue Infection, Complicated Streptococcus Pyogenes Skin And Skin Structure Infection, Skin & Soft Tissue Streptococcal Infection, Skin & Soft Tissue Streptococcus Infection.
Dosing
Dosage of dalbavancin hydrochloride is expressed in terms of dalbavancin.
Dalbavancin hydrochloride is administered by IV infusion.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
Formal drug interaction studies have not been conducted with dalbavancin to date.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Dalbavancin is contraindicated in patients with known hypersensitivity to the drug.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects reported in 2% or more of patients receiving dalbavancin include nausea, vomiting, diarrhea, headache, rash, and pruritus.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Safety and efficacy of dalbavancin have not been established in pediatric patients.
Category C. (See Users Guide.)
There are no adequate and well-controlled studies of dalbavancin in pregnant women, and the drug should be used during pregnancy only if potential benefits justify potential risks to the fetus.
In an embryofetal study in rats, delayed fetal maturation was observed at a dosage of 45 mg/kg daily (3.5 times the human dosage on an exposure basis). In a prenatal and postnatal development study in rats, increased embryolethality and increased offspring deaths during the first week postpartum were observed at a dosage of 45 mg/kg daily.
Dalbavancin is distributed into milk in lactating rats; it is not known whether the drug is distributed into human milk.
Dalbavancin should be used with caution in nursing women.
Dosage adjustments are not needed in geriatric patients based solely on age. Dosage should be selected with caution since geriatric patients are more likely to have decreased renal function than younger adults. (See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)
In clinical studies evaluating dalbavancin for the treatment of acute bacterial skin and skin structure infections, efficacy and tolerability were similar to comparator treatments regardless of age.
There were no substantial differences in the pharmacokinetics of dalbavancin according to age; therefore, dosage adjustments are not needed based solely on age.
Dalbavancin is substantially eliminated by the kidneys; the risk of adverse effects may be greater in patients with impaired renal function. Dosage should be selected with caution since geriatric patients are more likely to have decreased renal function.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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