Dalbavancin

Indications

Dalbavancin is used for: Indicated 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 Hepatic impairment Mild (Child-Pugh A): No dosage adjustment required Moderate or severe (Child-Pugh B and C): Cautions, no data are available

Child Dose

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 Category: C No evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively) Delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis) Lactation: Unknown if distributed in human breast milk Excreted in milk of lactating rats

Interactions

Side Effects

Side effects of Dalbavancin : 2-10% Nausea (5.5%) Headache (4.7%) Diarrhea (4.4%) Vomiting (2.8%) Rash (2.7%) Pruritus (2.1%) <2% 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 Metabolism and nutrition disorders: Hypoglycemia Nervous system disorders: Dizziness Respiratory, thoracic and mediastinal disorders: Bronchospasm Skin and subcutaneous tissue disorders: Urticaria Vascular disorders: Flushing, phlebitis, wound hemorrhage, spontaneous hematoma

Mode 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