Dalbavancin

Indications

Dalbavancin is used for: Acute bacterial, skin and skin structure infections (ABSSSI), caused by gram-positive bacteria

Adult Dose

Skin & Skin Structure Infections Indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by gram-positive bacteria 1-dose regimen of 1500 mg IV, or 2-dose regimen of 1000 mg IV followed 1 week later by 500 mg IV Infuse IV over 30 minutes

Child Dose

Skin & Skin Structure Infections Indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria in pediatric patients from birth Birth to <6 years: 22.5 mg/kg IV as a single dose 6 to <18 years: 18 mg/kg IV as a single dose Not to exceed 1500 mg/dose Infuse IV over 30 minutes

Renal Dose

Renal impairment CrCl <30 mL/min 1-dose regimen: Decrease dose to 1125 mg IV 2-dose regimen: Decrease dose to 750 mg IV followed 1 week later by 375 mg IV If receiving regularly scheduled hemodialysis: No dosage adjustment required

Administration

IV Preparation Reconstitution Reconstitute under aseptic conditions, using 25 mL of sterile water for injection for each 500-mg vial To avoid foaming, alternate between gentle swirling and inversion of the vial until its contents are completely dissolved Do NOT shake Reconstituted vial contains 20 mg/mL Reconstituted solution should appear clear and colorless to yellow Dilution Aseptically transfer the required dose of reconstituted solution from the vial(s) to IV bag or bottle containing D5W Final concentration of diluted solution must be between 1 mg/mL and 5 mg/mL Discard any unused portion of the reconstituted vials IV Administration Visually inspect for particulate matter before infusion If common IV line is being used to administer other drugs in addition to dalbavancin, the line should be flushed before and after each dose Infuse IV over 30 minutes Infusion-related reactions associated with rapid IV infusion

Contra Indications

Hypersensitivity

Precautions

Serious hypersensitivity (anaphylactic) and skin reactions reported with glycopeptide antibacterial agents, including dalbavancin Rapid IV infusion of glycopeptide antibacterial agents can cause reactions, including upper body flushing, urticaria, pruritus, and rash ALT elevations >3x ULN reported Clostridium difficile-associated diarrhea (CDAD) reported with nearly all systemic antibacterial agents, including dalbavancin; evaluate if diarrhea occurs Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit and increases the risk of the development of drug-resistant bacteria

Pregnancy-Lactation

Pregnancy 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 No treatment-related malformations or embryo-fetal toxicity were observed in pregnant rats or rabbits at clinically relevant exposures of dalbavancin Treatment of pregnant rats with dalbavancin at 3.5 times the human dose on an exposure basis during early embryonic development and from implantation to the end of lactation resulted in delayed fetal maturation and increased fetal loss, respectively Lactation There are no data on presence of dalbavancin or its metabolite in human milk, effects on breastfed child, or on milk production Dalbavancin is excreted in the milk of lactating rats; when a drug is present in animal milk, it is likely that the drug will be present in human milk The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition

Interactions

Adverse Effects

Side effects of Dalbavancin : 1-10% Adults Nausea (5.5%) Headache (4.7%) Diarrhea (4.4%) Vomiting (2.8%) Rash (2.7%) Pruritus (2.1%) <2% (adults) 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%) <1% Adults Elevated ALT, >3x ULN (0.8%) Pediatrics Gastrointestinal disorders: Diarrhea Nervous system disorders: Dizziness Skin and subcutaneous tissue disorders: Pruritus

Mechanism of Action

Lipoglycopeptide antibiotic; interferes with cell wall synthesis by binding to D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, thus preventing cross-linking Bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes at concentrations observed in humans at recommended doses