DALVANCE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DALVANCE (DALVANCE).
Dalbavancin is a lipoglycopeptide antibiotic that inhibits bacterial cell wall synthesis by binding to the D-alanyl-D-alanine terminus of peptidoglycan precursors, preventing transglycosylation and transpeptidation.
| Metabolism | Dalbavancin undergoes slow hepatic metabolism via unknown enzymes; it does not significantly inhibit or induce CYP450 isoenzymes. |
| Excretion | Primarily eliminated as unchanged drug via renal excretion (approximately 80% of administered dose). A minor amount (5%) is excreted in feces as unchanged drug. The remainder is metabolized, but no active metabolites are formed. |
| Half-life | Terminal elimination half-life is approximately 257 hours (about 10.7 days), supporting a once-weekly dosing regimen (week 1 loading dose). Prolonged half-life allows sustained exposure. |
| Protein binding | Highly protein-bound, 90-99%, primarily to human serum albumin. Binding is concentration-dependent. |
| Volume of Distribution | Volume of distribution at steady state is approximately 0.41 L/kg (range 0.27-0.55 L/kg), indicating distribution into extracellular fluid and some tissue binding. Does not penetrate cerebrospinal fluid well. |
| Bioavailability | Only available as intravenous infusion. Oral bioavailability is negligible and not clinically relevant. Bioavailability by IV route is 100%. |
| Onset of Action | Intravenous administration: Clinical effect is typically observed within 1-2 hours after completion of infusion, as measured by microbiological activity. Time to peak plasma concentration is at end of infusion (1-1.5 hours). |
| Duration of Action | Duration is prolonged due to long elimination half-life; once-weekly dosing maintains therapeutic levels. Clinical improvements are sustained throughout the weekly dosing interval. No accumulation beyond steady state (achieved by week 3). |
15-20 mg/kg intravenously once daily for 7-14 days
| Dosage form | POWDER |
| Renal impairment | For GFR 30-50 mL/min: 15 mg/kg/day. For GFR 10-29 mL/min: 10 mg/kg/day. For GFR <10 mL/min or hemodialysis: 10 mg/kg every 48 hours. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | For neonates: loading dose 20 mg/kg, then 10 mg/kg every 24-48 hours. For infants and children: 15-20 mg/kg every 24 hours. |
| Geriatric use | No specific dose adjustment based on age alone; adjust based on renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DALVANCE (DALVANCE).
| Breastfeeding | Unknown if excreted in human milk. No M/P ratio available. Caution advised; consider developmental and health benefits of breastfeeding versus mother's need for drug. |
| Teratogenic Risk | Animal studies show no evidence of teratogenicity at doses up to 4 times the human dose. No adequate human studies in pregnant women. Risk cannot be ruled out; use only if clearly needed. Potential fetal harm due to maternal toxicity at high doses. |
| Fetal Monitoring |
■ FDA Black Box Warning
Not applicable; no black box warning has been issued by the FDA for Dalvance.
| Serious Effects |
["Known hypersensitivity to dalbavancin or any component of the formulation"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis and infusion reactions","Rapid IV infusion may cause red-man syndrome","Use with caution in patients with renal impairment (dose adjustment required for CrCl <30 mL/min)","Potential for development of antibiotic-resistant bacteria"] |
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| Monitor for signs of hypersensitivity reactions, infusion-related reactions, Clostridioides difficile-associated diarrhea, and renal function. In pregnancy, monitor for maternal adverse effects and fetal growth if prolonged use. |
| Fertility Effects | No human fertility studies. Animal studies show no impairment of fertility at clinically relevant doses. |