Version May 2024
Endocarditis, treatment, step-down therapy in patients who inject drugs (alternative agent) (off-label use):
Note: Not first-line treatment; based on expert opinion. Reserve use for patients who inject drugs who had initial clinical improvement with IV treatment for S. aureus infection but cannot complete IV standard of care therapy and are unable to absorb oral antibiotics (Ref).
IV: 1 g as a single dose, followed by 500 mg weekly or 1.5 g as a single dose followed by 1 g every other week for a total duration, including initial IV therapy, of 6 weeks (Ref).
Skin and soft tissue infection (alternative agent):
Note: Reserve for patients with or at risk for methicillin-resistant S. aureus infection who cannot receive preferred agents (Ref).
IV: 1.5 g as a single dose (Ref) or 1 g as a single dose initially, followed by 500 mg as a single dose 1 week later (Ref); the single dose has been shown to be as effective as the two-dose regimen (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute (not on regularly scheduled dialysis):
Single-dose regimen: 1.125 g as a single dose.
Two-dose regimen: 750 mg as a single dose initially, followed by 375 mg as a single dose 1 week later.
End-stage renal disease patients receiving intermittent hemodialysis (regularly scheduled): No dosage adjustment necessary; administer without regard to timing of hemodialysis.
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate or severe impairment (Child-Pugh class B or C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.
Refer to adult dosing.
(For additional information see "Dalbavancin: Pediatric drug information")
Skin and soft tissue infection:
Infants and Children <6 years: IV: 22.5 mg/kg as a single dose; maximum dose: 1,500 mg/dose.
Children ≥6 years and Adolescents: IV: 18 mg/kg as a single dose; maximum dose: 1,500 mg/dose.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Altered kidney function: Infants, Children, and Adolescents: IV:
CrCl ≥30 mL/minute/1.73 m2: No adjustment necessary.
CrCl <30 mL/minute/1.73 m2: There are no pediatric-specific dosage adjustments provided in the manufacturer's labeling (has not been studied); however, adult pharmacokinetic information shows a decrease in clearance by 47% in patients with CrCl of <30 mL/minute; based on adult recommendations, dosage adjustment may be necessary in patients with CrCl <30 mL/minute not on regularly scheduled dialysis.
Hemodialysis: <6% removed by 3 hour dialysis session. There are no pediatric-specific dosage adjustments provided in the manufacturer's labeling (has not been studied); in adults with end-stage kidney disease receiving regularly scheduled hemodialysis, no adjustment is necessary and may administer without regards to timing of dialysis.
Infants, Children, and Adolescents: IV:
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate or severe impairment (Child-Pugh class B or C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions are for adults unless otherwise specified.
1% to 10%:
Cardiovascular: Flushing (<2%), phlebitis (<2%)
Dermatologic: Pruritus (2%), skin rash (3%), urticaria (<2%)
Endocrine & metabolic: Hypoglycemia (<2%), increased gamma-glutamyl transferase (<2%), increased lactate dehydrogenase (<2%)
Gastrointestinal: Abdominal pain (<2%), Clostridioides difficile colitis (<2%), diarrhea (4%), gastrointestinal hemorrhage (<2%), hematochezia (<2%), melena (<2%), nausea (6%), oral candidiasis (<2%), vomiting (3%)
Genitourinary: Vulvovaginal infection (mycotic; <2%)
Hematologic & oncologic: Acute posthemorrhagic anemia (<2%), anemia (<2%), eosinophilia (<2%), hematoma (spontaneous; <2%), increased INR (<2%), leukopenia (<2%), neutropenia (<2%), petechia (<2%), thrombocythemia (<2%), thrombocytopenia (<2%), wound hemorrhage (<2%)
Hepatic: Hepatotoxicity (<2%), increased serum alkaline phosphatase (<2%), increased serum transaminases (<2%)
Hypersensitivity: Anaphylaxis (<2%)
Nervous system: Dizziness (<2%), headache (5%)
Respiratory: Bronchospasm (<2%)
Miscellaneous: Fever (pediatric patients: 1%), infusion related reaction (<2%)
<1%: Hepatic: Increased serum alanine aminotransferase (>3 x ULN)
Postmarketing:
Gastrointestinal: Clostridioides difficile-associated diarrhea
Hypersensitivity: Hypersensitivity reaction
Neuromuscular & skeletal: Back pain
Hypersensitivity to dalbavancin or any component of the formulation
Concerns related to adverse effects:
• Hepatic effects: Patients with normal baseline transaminase levels may have ALT elevation >3 times the upper limit of normal (ULN) during therapy; in clinical studies, abnormalities in liver tests (ALT, AST, bilirubin) were reported with similar frequency in the dalbavancin and comparator arms. ALT elevations were reversible after discontinuation.
• Hypersensitivity reactions: Serious hypersensitivity (anaphylactic) and skin reactions have been reported with dalbavancin. Discontinue treatment if an allergic reaction occurs. Dalbavancin cross-sensitivity to other glycopeptides may occur; exercise caution in patients with a history of glycopeptide allergy; carefully screen for previous hypersensitivity reactions to glycopeptides prior to administration.
• Infusion reactions: Rapid intravenous infusions of dalbavancin (<30 minutes) may cause reactions that resemble vancomycin infusion reaction (formerly "red man syndrome") (eg, flushing of the upper body, urticaria, pruritus, rash). Stopping or slowing the infusion may result in cessation of these reactions (Alvarez-Arango 2021).
• Superinfection: Use may result in fungal or bacterial superinfection, including Clostridioides difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment (Child-Pugh class B or C).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
Dalvance: 500 mg (1 ea)
No
Solution (reconstituted) (Dalvance Intravenous)
500 mg (per each): $2,134.96
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Xydalba: 500 mg (1 ea) [contains lactose monohydrate]
IV: Infuse over 30 minutes. If a common IV line is being used to administer other drugs in addition to dalbavancin, the line should be flushed before and after each infusion with D5W.
Parenteral: IV: Infuse over 30 minutes. If a common IV line is being used to administer other drugs in addition to dalbavancin, the line should be flushed before and after each infusion with D5W.
IV infusion: 500 to 1,500 mg in 100 to 1,500 mL (concentration of 1 to 5 mg/mL) of D5W.
Skin and soft tissue infections: Treatment of adult and pediatric patients with acute bacterial skin and soft tissue infections caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, S. dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates).
Endocarditis, treatment, step-down therapy in patients who inject drugs:
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Adverse events have been observed in animal reproduction studies.
Information related to dalbavancin in pregnancy is limited. A case report describes use of dalbavancin for ~4 weeks during the last month of pregnancy for the treatment of methicillin-resistant S. aureus endocarditis. Treatment was unsuccessful. Following therapy, blood cultures grew vancomycin-intermediate S. aureus requiring treatment with multiple antibiotics (Steele 2018). The long half-life of dalbavancin should be considered when evaluating potential exposure to the fetus.
It is not known if dalbavancin is present in breast milk.
A case report describes use of dalbavancin in a lactating patient who presented with mammary dysbiosis and multiple nipple blebs 6 months postpartum. Breast milk cultures were positive for multidrug-resistant methicillin-resistant S. aureus. The patient received 2 doses of dalbavancin, the first at 6 months postpartum and the second 2 weeks later. Breast milk cultures were negative at 7 months postpartum. The child was exclusively fed expressed breast milk prior to and throughout dalbavancin therapy. Adverse events were not observed in the mother or infant (Mitchell 2020).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Baseline BUN, serum creatinine, and liver function tests (AST, ALT, bilirubin). Monitor patients for any infusion-related reactions and for superinfection during therapy.
Dalbavancin is a lipoglycopeptide which binds to the D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, preventing cross-linking and interfering with cell wall synthesis. It is bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes
Distribution: Vd: 7 to 13 L (Leighton, 2004)
Protein binding: 93% (primarily to albumin)
Metabolism: Minor metabolite (hydroxy-dalbavancin)
Half-life elimination: 346 hours
Excretion: Urine (33% as unchanged drug, 12% as hydroxy metabolite); feces (20%)
Altered kidney function: Mean plasma clearance reduced 11%, 35%, and 47% in subjects with mild (CrCl 50 to 79 mL/minute), moderate (CrCl 30 to 49 mL/minute), and severe (CrCl <30 mL/minute) renal impairment, respectively.
Hepatic function impairment: Mean AUC0-336 hrs decreased 28% and 31% in Child-Pugh class B and C patients, respectively.
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