Dalbavancin hydrochloride, a lipoglycopeptide antibacterial, is a semisynthetic derivative of a naturally occurring glycopeptide.1, 2, 3, 18
Skin and Skin Structure Infections
Dalbavancin hydrochloride is used for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Staphylococcus aureus (including methicillin-resistant S. aureus [MRSA; also known as oxacillin-resistant S. aureus or ORSA] and methicillin-susceptible S. aureus ), Streptococcus pyogenes (group A β-hemolytic streptococci, GAS), S. agalactiae (group B streptococci, GBS), or S. anginosus group (includes S. anginosus, S. intermedius , and S. constellatus ).1
Efficacy and safety of dalbavancin were evaluated in 2 randomized, multicenter, double-blind, noninferiority, phase 3 studies (DISCOVER 1 and DISCOVER 2) in adults with acute bacterial skin and skin structure infections (e.g., cellulitis, major abscess, or wound infection, each associated with at least 75 cm2 of erythema).1, 5 Patients had at least 2 local signs of infection (e.g., purulent drainage or discharge, fluctuance, localized warmth, tenderness, swelling or induration) and were thought to require at least 3 days of IV therapy or had least 1 sign of systemic infection at baseline (e.g., temperature 38°C or higher, leukocyte count greater than 12,000 cells/mm3, 10% or more band forms on leukocyte differential).1, 5 Over 1300 patients (mean age 50 years, 57-60% male, 12-14% with diabetes mellitus, 14-16% IV drug users, 53-54% with cellulitis, 25-27% with major abscess, 20-21% with wound or surgical site infection, median baseline lesion area 341 cm2) were randomized to receive a 2-dose regimen of dalbavancin (1 g IV on day 1 followed by 500 mg IV on day 8; those with creatinine clearance less than 30 mL/minute received 750 mg IV on day 1 followed by 375 mg on day 8) or a 10-14 day regimen of vancomycin (1 g or 15 mg/kg IV every 12 hours) with the option to switch to oral linezolid (600 mg every 12 hours) after 3 days of vancomycin.1, 5 Protocol-specified empiric gram-negative coverage with aztreonam could be used concomitantly.1 In a pooled analysis of both studies using data at 48-72 hours after initiation of treatment, the dalbavancin regimen was noninferior to the vancomycin regimen.5 Clinical response (i.e., no increase in lesion area from baseline, temperature consistently 37.6°C or less) was achieved in 79.7% of those receiving dalbavancin and 79.8% of those receiving the vancomycin regimen.1, 5 A similar proportion of patients receiving dalbavancin or the vancomycin regimen (88.6 or 88.1%, respectively) achieved a 20% or greater reduction in lesion area from baseline at 48-72 hours.1, 5 In the subset of patients who were microbiologically evaluable and stratified according to the infecting pathogen, the clinical success rate (defined as decrease in lesion size, temperature of 37.6° C or less, and meeting pre-specified criteria for local signs of infection) on day 26-30 in those with infections caused by MRSA or methicillin-susceptible S. aureus was 83 or 85%, respectively, in those treated with dalbavancin and 85 or 91%, respectively, in those treated with the vancomycin regimen.1 The clinical success rate in those with infections caused by S. agalactiae , S. pyogenes , or S. anginosus group was 83, 89, or 96%, respectively, in those treated with dalbavancin and 79, 89, or 92%, respectively, in those treated with the vancomycin regimen.1
Dalbavancin was evaluated in a randomized, double-blind, phase 3 study in 854 adults with complicated skin and skin structure infections (e.g., major abscess, major burn, traumatic or surgical wound infection, extensive or ulcerating cellulitis, infection suspected to be caused by MRSA) with at least 2 signs of local infection and at least 1 sign of systemic infection.6 Patients were randomized in a 2:1 ratio to receive dalbavancin (1 g IV on day 1 followed by 500 mg IV on day 8) or a 14-day regimen of linezolid (600 mg IV every 12 hours) with the option to switch to oral linezolid.6 Empiric coverage with aztreonam and/or metronidazole could be used concomitantly.6 Baseline characteristics were balanced between groups (61-62% male, 30-33% major abscess, 27-30% cellulitis); however, there was a higher proportion of patients with vascular disease in the dalbavancin group than in the linezolid group (11 and 6%, respectively).6 Of the clinically evaluable patients at the test-of-cure visit (approximately 14 days after completion of treatment), 88.9% of patients in the dalbavancin group and 91.2% of patients in the linezolid group achieved clinical success (i.e., improvement of signs and symptoms of infection such that no further antibacterial therapy was needed).6 In the subset of patients who were microbiologically evaluable, the microbiologic success rate at the test-of-cure visit was 90% in those treated with dalbavancin and 88% in those treated with linezolid; MRSA eradication rates at the test-of-cure visit were 91 or 89% in the dalbavancin or linezolid groups, respectively.6
Dalbavancin hydrochloride is administered by IV infusion.1
If the same IV line is used for sequential infusion of dalbavancin and other drugs, the IV line should be flushed with 5% dextrose injection before and after the dalbavancin infusion.1
Dalbavancin solutions should not be infused with other drugs or electrolytes.1 Dalbavancin solutions are compatible with 5% dextrose injection, but compatibility with other IV solutions, drugs, additives, or substances has not been established.1
Vials of dalbavancin lyophilized powder for injection contain no preservatives and are intended for single use only.1
Dalbavancin hydrochloride for injection must be reconstituted and further diluted prior to IV infusion.1 Strict aseptic technique must be observed when preparing IV solutions of the drug.1
Vials labeled as containing 500 mg of dalbavancin should be reconstituted by adding 25 mL of sterile water for injection to provide a solution containing 20 mg/mL.1 To avoid foaming, the vial should be alternately swirled and inverted until vial contents are completely dissolved; the vial should not be shaken.1 The reconstituted solution should appear clear and colorless to yellow.1
Reconstituted dalbavancin must then be further diluted by withdrawing the correct dose of the drug from the reconstituted vial(s) and adding it to an IV bag or bottle containing 5% dextrose injection.1 The final diluted solution must have a dalbavancin concentration of 1-5 mg/mL.1 Any unused portion of reconstituted solution should be discarded.1
Reconstituted or further diluted solutions of dalbavancin may be stored under refrigeration (2-8°C) or at controlled room temperature (i.e., 20-25°C), but should not be frozen.1 Total storage time from the time of reconstitution to administration should not exceed 48 hours whether refrigerated at 2-8°C or stored at room temperature.1
Dalbavancin solutions should be inspected visually for particulate matter prior to administration.1
Dalbavancin solutions should be administered by IV infusion over 30 minutes.1
Dosage of dalbavancin hydrochloride is expressed in terms of dalbavancin.1
Skin and Skin Structure Infections
The recommended dosage of dalbavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults is a 2-dose regimen of 1 g given by IV infusion followed 1 week later by 500 mg given by IV infusion.1
Dosage adjustments are not needed in adults with mild (creatinine clearance 50-79 mL/minute) or moderate (creatinine clearance 30-49 mL/minute) renal impairment.1
Adults with severe renal impairment (creatinine clearances less than 30 mL/minute) not receiving regularly scheduled hemodialysis should receive a 2-dose regimen of 750 mg of dalbavancin given by IV infusion followed 1 week later by 375 mg given by IV infusion.1
Dosage adjustments are not recommended for adults with renal impairment receiving regularly scheduled hemodialysis; dalbavancin may be administered in such patients without regard to hemodialysis timing.1 (See Renal Impairment under Warnings/Precautions: Specific Populations, in Cautions.)
Dosage adjustments are not needed in adults with mild hepatic impairment (Child-Pugh class A).1
Dosage recommendations for those with moderate or severe hepatic impairment (Child-Pugh class B or C) are not available;1 the drug should be used with caution in such individuals.1 (See Hepatic Impairment under Warnings/Precautions: Specific Populations, in Cautions.)
Dosage adjustments are not needed in geriatric patients based solely on age.1 Dosage should be selected with caution since geriatric patients are more likely to have decreased renal function than younger adults.1 (See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)
Dalbavancin is contraindicated in patients with known hypersensitivity to the drug.1
Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients receiving dalbavancin.1
Data are not available to date regarding cross-reactivity between dalbavancin and other glycopeptides (e.g., oritavancin, telavancin, vancomycin).1 Because of the possibility of cross-sensitivity, patients should be questioned about previous hypersensitivity reactions to glycopeptides and dalbavancin should be used with caution in those with a history of glycopeptide allergy.1
If an allergic reaction occurs, dalbavancin should be discontinued.1
Rapid IV infusion of dalbavancin can cause a reaction referred to as “red-man syndrome” (i.e., flushing of the upper body, urticaria, pruritus, rash).1
To reduce the risk of infusion-related reactions, IV infusions of dalbavancin should be given over 30 minutes.1 If an infusion-related reaction occurs, stopping or decreasing the infusion rate may result in cessation of symptoms.1
In patients with normal baseline aminotransferase concentrations in phase 2 and phase 3 clinical trials, more dalbavancin-treated patients developed ALT elevations greater than 3 times the upper limit of normal (ULN) compared with patients receiving a comparator treatment (0.8 or 0.2%, respectively).1 Overall, the frequency of liver laboratory test abnormalities (e.g., ALT, AST, bilirubin) was similar in patients receiving dalbavancin or a comparator treatment.1
Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)
Use of dalbavancin may result in emergence and overgrowth of nonsusceptible bacteria or fungi.1 The patient should be carefully monitored and appropriate therapy instituted if superinfection occurs.1
Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile .1, 12, 14, 15 C. difficile infection (CDI) and C. difficile -associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) have been reported in patients receiving nearly all anti-infectives, including dalbavancin, and may range in severity from mild diarrhea to fatal colitis.1, 12, 14, 15 C. difficile produces toxins A and B which contribute to development of CDAD;1, 12 hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1
CDAD should be considered in the differential diagnosis of patients who develop diarrhea during or after anti-infective therapy.1, 12, 14, 15 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.1
If CDAD is suspected or confirmed, anti-infective therapy not directed against C. difficile should be discontinued whenever possible.1, 12 Patients should be managed with appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.1, 12, 14, 15
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of dalbavancin and other antibacterials, the drug should be used only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.1
When selecting or modifying anti-infective therapy, results of culture and in vitro susceptibility testing should be used.1 In the absence of such data, local epidemiology and susceptibility patterns should be considered when selecting anti-infectives for empiric therapy.1
Category C.1 (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.1
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).1 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.1
Dalbavancin is distributed into milk in lactating rats;1 it is not known whether the drug is distributed into human milk.1
Dalbavancin should be used with caution in nursing women.1
Safety and efficacy of dalbavancin have not been established in pediatric patients.1
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.1
There were no substantial differences in the pharmacokinetics of dalbavancin according to a therefore, dosage adjustments are not needed based solely on age.1
Dalbavancin is substantially eliminated by the kidneys; the risk of adverse effects may be greater in patients with impaired renal function.1 Dosage should be selected with caution since geriatric patients are more likely to have decreased renal function.1
Dalbavancin should be used with caution in patients with moderate or severe hepatic impairment (Child-Pugh class B or C);1 there are no data available to determine an appropriate dosage of the drug in such patients.1 The mean area under the plasma concentration-time curve (AUC) of dalbavancin is decreased by 28 or 31% in patients with moderate or severe hepatic impairment (Child-Pugh class B or C);1, 11 however, the clinical importance of decreased AUC in such patients has not been established.1
Dalbavancin pharmacokinetics are not altered in patients with mild hepatic impairment (Child-Pugh class A).1, 11
In patients with mild, moderate, or severe renal impairment, mean plasma clearance of dalbavancin is decreased by 11, 35, or 47%, respectively, and AUC is increased compared with patients with normal renal function.1, 11 Dalbavancin pharmacokinetics in patients with end-stage renal disease receiving regularly scheduled hemodialysis are similar to those in patients with mild to moderate renal impairment.1, 11
Patients with creatinine clearance less than 30 mL/minute who are not receiving regularly scheduled hemodialysis should receive reduced dalbavancin dosage.1, 11 (See Renal Impairment under Dosage and Administration: Special Populations.)
Adverse effects reported in 2% or more of patients receiving dalbavancin include nausea,1, 5, 6 vomiting,1 diarrhea,1, 6 headache,1 rash,1 and pruritus.1
Formal drug interaction studies have not been conducted with dalbavancin to date.1
Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes
Based on in vitro studies, dalbavancin is not a substrate, inhibitor, or inducer of cytochrome P-450 (CYP) isoenzymes,1, 9 and there is minimal potential that the drug will interact with substrates, inhibitors, or inducers of CYP isoenzymes.1 Results of a population pharmacokinetic analysis indicate that dalbavancin pharmacokinetics are not affected when the drug is used concomitantly with known CYP isoenzyme substrates, inducers, inhibitors, or other tested drugs (e.g., acetaminophen, aztreonam, fentanyl, metronidazole, furosemide, proton-pump inhibitors [omeprazole, esomeprazole, pantoprazole, lansoprazole], midazolam, simvastatin).1, 9
Dalbavancin pharmacokinetics do not appear to be affected by concomitant use of aztreonam or metronidazole.1, 9
In vitro studies indicate that the antibacterial effects of dalbavancin and oxacillin are synergistic against some gram-positive bacteria (methicillin-resistant Staphylococcus aureus [MRSA; also known as oxacillin-resistant S. aureus or ORSA]).1, 4, 16
In vitro studies indicate that the antibacterial effects of dalbavancin and aztreonam, clindamycin, daptomycin, gentamicin, levofloxacin, linezolid, quinupristin and dalfopristin, rifampin, or vancomycin are not synergistic or antagonistic.1
Dalbavancin hydrochloride is a semisynthetic lipoglycopeptide antibacterial derived from a naturally occurring glycopeptide produced by Nonomuraea , an actinomycete.1, 2, 3, 18 The drug is a teicoplanin-type lipoglycopeptide and contains a heptapeptide core structure that differs from that of vancomycin.3, 18 Dalbavancin is a mixture of 5 closely related homologs (i.e., A0, A1, B0, B1, B2), each sharing the same core structure.1 Of the 5 homologs, B0 is the major component of dalbavancin.1
The mechanism of action of dalbavancin is similar to that of other glycopeptides (e.g., oritavancin, telavancin, vancomycin).18 Dalbavancin binds to the d-alanyl-d-alanine terminus of growing peptidoglycan chains, thereby inhibiting bacterial cell wall synthesis.1, 2, 4 The drug also appears to dimerize and anchor in the bacterial membranes.2, 4, 18
In vitro, dalbavancin is bactericidal in action against certain gram-positive bacteria, including staphylococci, streptococci, and enterococci.1, 7 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]),1, 4, 5, 8, 13 S. pyogenes (group A β-hemolytic streptococci, GAS),1, 4, 5, 8, 13 S. agalactiae (group B streptococci, GBS),1, 4, 8 and S. anginosus group (includes S. anginosus, S. intermedius , and S. constellatus ).1 Dalbavancin also is active in vitro against some vancomycin-susceptible Enterococcus faecium and E. faecalis ;1, 4, 18 however, safety and efficacy of the drug in treating clinical infections caused by these bacteria have not been established.1 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.2, 13, 16, 18
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.1, 7 Certain intrinsically glycopeptide-resistant bacteria and those expressing the VanA phenotype of acquired resistance to vancomycin also may be resistant to dalbavancin.16 Cross-resistance between dalbavancin and nonglycopeptide anti-infectives is unlikely.16
Dalbavancin exhibits linear, dose-dependent pharmacokinetics following IV administration, and there is no apparent accumulation following multiple IV doses of the drug.1, 4 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.17 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.1, 10 The drug is approximately 93% bound to plasma proteins, mainly albumin.1 Dalbavancin is not a substrate, inhibitor, or inducer of cytochrome P-450 (CYP) isoenzymes;1 a minor metabolite, hydroxydalbavancin, has been detected in urine.1 Based on population pharmacokinetic analyses, the effective half-life of dalbavancin is approximately 8.5 days (204 hours).1, 9 Following a single 1-g dose of dalbavancin, 20% of a dose is eliminated in feces by day 70 after the dose.1 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.1 Less than 6% of an administered dose of dalbavancin is removed after 3 hours of hemodialysis.1
Advise patients that antibacterials (including dalbavancin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1
Importance of completing full course of therapy, even if feeling better after a few days.1
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with dalbavancin or other antibacterials in the future.1
Advise patients that allergic reactions, including serious allergic reactions, could occur and require immediate treatment.1 Importance of informing clinician about any previous hypersensitivity reactions to dalbavancin or other glycopeptides (e.g., oritavancin, telavancin, vancomycin).1
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Additional Information
Overview® (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection, for IV infusion | 500 mg (of dalbavancin) |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions April 7, 2015. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
1. Dalvance. Durata Therapeutics® (dalbavancin) for injection prescribing information. Chicago, IL; 2014 May.
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3. Sosio M, Donadio S. Understanding and manipulating glycopeptide pathways: the example of the dalbavancin precursor A40926. J Ind Microbiol Biotechnol . 2006; 33:569-76. [PubMed 16761167]
4. Chen AY, Zervos MJ, Vazquez JA. Dalbavancin: a novel antimicrobial. Int J Clin Pract . 2007; 61:853-63. [PubMedCentral][PubMed 17362476]
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16. US Food and Drug Administration. Center for Drug Evaluation and Research: Application number 021883Orig1s000: Microbiology/virology review. 2014 Feb 20. From FDA website. [Web]
17. Dorr MB, Jabes D, Cavaleri M et al. Human pharmacokinetics and rationale for once-weekly dosing of dalbavancin, a semi-synthetic glycopeptide. J Antimicrob Chemother . 2005; 55 Suppl 2:ii25-30.
18. Allen NE. From vancomycin to oritavancin: the discovery and development of a novel lipoglycopeptide antibiotic. Anti-Infect Agents Med Chem . 2010; 9:23-47.