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Dalbavancin

    Brands

    DEA Class; Rx

    Common Brand Names; Dalvance

    • Glycopeptides

    Second-generation glycopeptide antibiotic
    Used for acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes in adults and pediatric patients as young as neonates
    Extended, weekly dosing and no routine serum concentration monitoring

    Indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria

    Susceptible isolates of Gram-positive microorganisms

    • Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant S aureus [MRSA])
    • Streptococcus pyogenes
    • Streptococcus agalactiae
    • Streptococcus dysgalactiae
    • Streptococcus anginosus group (including S anginosus, S intermedius, S constellatus)
    • Enterococcus faecalis (vancomycin-susceptible isolates)

    Hypersensitivity

    Adults

    • Nausea (5.5%)
    • Headache (4.7%)
    • Diarrhea (4.4%)
    • Vomiting (2.8%)
    • Rash (2.7%)
    • Pruritus (2.1%)
    • Blood and lymphatic system disorders: Anemia, hemorrhagic anemia, leukopenia, neutropenia, thrombocytopenia, petechiae, eosinophilia, thrombocytosis
    • Gastrointestinal disorders: Gastrointestinal hemorrhage, melena, hematochezia, abdominal pain
    • General disorders and administration site conditions: Infusion-related reactions
    • Hepatobiliary disorders: Hepatotoxicity
    • Immune system disorders: Anaphylactoid reaction
    • Infections and infestations: Clostridium difficile colitis, oral candidiasis, vulvovaginal mycotic infection
    • Investigations: Hepatic transaminases increased, blood alkaline phosphatase increased, INR ratio increased, blood lactate dehydrogenase increased, gamma-glutamyl transferase increased
    • Metabolism and nutrition disorders: Hypoglycemia
    • Nervous system disorders: Dizziness
    • Respiratory, thoracic and mediastinal disorders: Bronchospasm
    • Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria
    • Vascular disorders: Flushing, phlebitis, wound hemorrhage, spontaneous hematoma

    Pediatrics

    • Pyrexia (1.2%)

    Administer via intravenous infusion, using a total infusion time of 30 minutes to minimize risk of infusion-related reaction; rapid IV infusion of glycopeptide antibacterial agents can cause reactions, including upper body flushing, urticaria, pruritus, back pain, and rash; stopping or slowing infusion may result in cessation of these reactions

    ALT elevations >3x ULN reported

    Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection, or a prophylactic indication is unlikely to provide benefit and increases the risk of the development of drug-resistant bacteria

    There are no adequate and well-controlled studies with use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes

    There are no data on presence of dalbavancin or its metabolite in human milk, effects on breastfed child, or on milk production

    Adults

    1,500 mg IV.

    Geriatric

    1,500 mg IV.

    Adolescents

    18 mg/kg/dose (Max: 1,500 mg/dose) IV.

    Children

    6 to 12 years: 18 mg/kg/dose (Max: 1,500 mg/dose) IV.
    1 to 5 years: 22.5 mg/kg/dose IV.

    Infants

    22.5 mg/kg/dose IV.

    Neonates

    22.5 mg/kg/dose IV.

    Dalbavancin

    yophilized powder for reconstitution

    • 500mg/vial (20mg/mL after reconstitution)