Classes
DEA Class; Rx
Common Brand Names; Dalvance
- Glycopeptides
Description
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
Indications
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)
Contraindications
Hypersensitivity
Adverse Effects
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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
1,500 mg IV.
1,500 mg IV.
18 mg/kg/dose (Max: 1,500 mg/dose) IV.
6 to 12 years: 18 mg/kg/dose (Max: 1,500 mg/dose) IV.
1 to 5 years: 22.5 mg/kg/dose IV.
22.5 mg/kg/dose IV.
22.5 mg/kg/dose IV.
How supplied
Dalbavancin
yophilized powder for reconstitution
- 500mg/vial (20mg/mL after reconstitution)