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Dalbavancin

Generic name: dalbavancin systemic

Brand names: Dalvance

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Dalvance: 500 mg (1 ea)

Pharmacology

Mechanism of Action

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

Pharmacokinetics/Pharmacodynamics

Distribution

Vd: 7 to 13 L (Leighton, 2004)

Metabolism

Minor metabolite (hydroxy-dalbavancin)

Excretion

Urine (33% as unchanged drug, 12% as hydroxy metabolite); feces (20%)

Half-Life Elimination

346 hours

Protein Binding

93% (primarily to albumin)

Use in Specific Populations

Special Populations: Renal Function Impairment

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.

Special Populations: Hepatic Function Impairment

Mean AUC0-336 hrs decreased 28% and 31% in Child-Pugh class B and C patients, respectively.

Use: Labeled Indications

Acute bacterial skin and skin structure infections: Treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, S. dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus), and Enterococcus faecalis (vancomycin-susceptible strains)

Contraindications

Hypersensitivity to dalbavancin or any component of the formulation

Dosage and Administration

Dosing: Adult

Acute bacterial skin and skin structure infections: IV:

Single-dose regimen: 1,500 mg as a single dose

Two-dose regimen: 1,000 mg as a single dose initially, followed by 500 mg as a single dose 1 week later

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Acute bacterial skin and soft structure infections (ABSSSI): Very limited data: Note: Dosing based on pharmacokinetic modeling; the age-dependent dosing regimens were found to achieve similar dalbavancin exposure to adults (AUC0-120) (Gonzalez 2017):

Single-dose regimen (Gonzalez 2017):

≥3 months to <6 years: IV: 22.5 mg/kg as a single dose; maximum dose: 1,500 mg/dose.

≥6 years to <18 years: IV: 18 mg/kg as a single dose; maximum dose: 1,500 mg/dose.

Two-dose regimen (Gonzalez 2017):

≥3 months to <6 years: IV: 15 mg/kg as a single dose on day 1 (maximum dose: 1,000 mg/dose) then 7.5 mg/kg as a single dose on day 8 (maximum dose: 500 mg/dose).

≥6 years to <18 years: IV: 12 mg/kg as a single dose on day 1 (maximum dose: 1,000 mg/dose) then 6 mg/kg as a single dose on day 8 (maximum dose: 500 mg/dose).

Reconstitution

Reconstitute with 25 mL of either SWFI or D5W for each 500 mg vial. To avoid foaming, alternate between gentle swirling and inversion of the vial until contents are completely dissolved. Do not shake. The reconstituted vial contains 20 mg/mL dalbavancin as a clear, colorless to yellow solution. Dilute for infusion in D5W (final solution concentration 1 to 5 mg/mL).

Administration

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.

Storage

Store intact vials at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Reconstituted vials and diluted solution in D5W may be stored refrigerated at 2°C to 8°C (36°F to 46°F) or at room temperature 20°C to 25°C (68°F to 77°F). Do not freeze. The total time from reconstitution to dilution to administration should be ≤48 hours.

Drug Interactions

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). 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. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. 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. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Adverse Reactions

1% to 10%:

Cardiovascular: Flushing (<2%), phlebitis (<2%)

Central nervous system: Headache (5%), dizziness (<2%)

Dermatologic: Skin rash (3%), pruritus (2%), urticaria (<2%)

Endocrine & metabolic: Hypoglycemia (<2%), increased gamma-glutamyl transferase (<2%), increased lactate dehydrogenase (<2%)

Gastrointestinal: Nausea (6%), diarrhea (4%), vomiting (3%), abdominal pain (<2%), Clostridioides (formerly Clostridium) difficile colitis (<2%), gastrointestinal hemorrhage (<2%), hematochezia (<2%), melena (<2%), oral candidiasis (<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: Anaphylactoid reaction (<2%)

Infection: Vulvovaginal infection (mycotic; <2%)

Respiratory: Bronchospasm (<2%)

Miscellaneous: Infusion related reaction (<2%; including red man syndrome)

<1%, postmarketing, and/or case reports: Anaphylaxis, back pain, Clostridioides (formerly Clostridium) difficile-associated diarrhea, hypersensitivity reaction, increased serum alanine aminotransferase

Warnings/Precautions

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 “Red-Man Syndrome,” (eg, flushing of the upper body, urticaria, pruritus, rash). Stopping or slowing the infusion may result in cessation of these reactions.
  • Superinfection: Use may result in fungal or bacterial superinfection, including Clostridioides (formerly Clostridium) 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).

Concurrent drug therapy issues:

  • Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Monitoring Parameters

Baseline BUN, serum creatinine, and liver function tests (AST, ALT, bilirubin). Monitor patients for any infusion-related reactions and for superinfection during therapy.

Pregnancy

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. The long half-life of dalbavancin should be considered when evaluating potential exposure to the fetus.

Patient Education

What is this drug used for?

  • It is used to treat skin infections.

Frequently reported side effects of this drug

  • Diarrhea
  • Headache
  • Nausea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

  • Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.
  • Flushing
  • Infusion reaction
  • Clostridium difficile (C. diff)-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools.
  • Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Source: Wolters Kluwer Health. Last updated February 6, 2020.