DALBAVANCIN HYDROCHLORIDE
Clinical safety rating: safe
Animal studies have demonstrated safety
Dalbavancin inhibits bacterial cell wall synthesis by binding to the D-alanyl-D-alanine terminus of the peptidoglycan precursor, preventing transglycosylation and transpeptidation. It is a lipoglycopeptide antibiotic with bactericidal activity against Gram-positive bacteria.
| Metabolism | Dalbavancin is not extensively metabolized; minor metabolism via hydrolysis to hydroxy-dalbavancin and other minor metabolites. It is not a substrate for CYP450 enzymes. |
| Excretion | Primarily renal excretion of unchanged drug (33%) and its active metabolite (12%), with additional biliary/fecal elimination (approximately 20% in feces). |
| Half-life | Terminal elimination half-life of 14.4 days (range 8.5–16.0 days), permitting once-weekly dosing. |
| Protein binding | 93% bound to human plasma proteins, primarily albumin. |
| Volume of Distribution | Approximately 0.16 L/kg, indicating distribution primarily in plasma and interstitial fluid with limited tissue penetration. |
| Bioavailability | Not applicable; administered only via intravenous infusion; oral bioavailability is negligible. |
| Onset of Action | Intravenous: Time to clinical response is variable, with initial bactericidal effect within 24–48 hours; clinical improvement typically observed within 72 hours. |
| Duration of Action | Antibacterial activity persists for at least 14 days following a single intravenous dose due to long half-life, supporting once-weekly dosing. |
1500 mg intravenously as a single dose, or 1000 mg intravenously followed by 500 mg intravenously one week later.
| Dosage form | POWDER |
| Renal impairment | CrCl 30-49 mL/min: 1125 mg intravenously as a single dose, or 750 mg intravenously followed by 375 mg one week later. CrCl 15-29 mL/min: 750 mg intravenously as a single dose, or 500 mg intravenously followed by 250 mg one week later. CrCl <15 mL/min or hemodialysis: Not recommended. |
| Liver impairment | Mild to moderate hepatic impairment (Child-Pugh A or B): No dosage adjustment required. Severe hepatic impairment (Child-Pugh C): Not studied; use with caution. |
| Pediatric use | Safety and efficacy not established in pediatric patients <18 years of age. |
| Geriatric use | No specific dose adjustment recommended; use standard adult dosing with attention to renal function due to age-related decline in CrCl. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
No significant drug interactions Prolonged terminal half-life allows for once-weekly dosing.
| Breastfeeding | Unknown if excreted in human milk; M/P ratio not available. Caution recommended; consider developmental and health benefits of breastfeeding. |
| Teratogenic Risk | No adequate human data; animal studies show no teratogenicity at up to 0.5 times human dose (AUC). Potential for fetal toxicity due to maternal toxicity at high doses. Risk cannot be excluded; use only if benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Common Effects | Nausea |
| Serious Effects |
["Hypersensitivity to dalbavancin or other lipoglycopeptide antibiotics (e.g., telavancin, oritavancin)"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis have been reported","Rapid infusion may cause infusion-related reactions (e.g., flushing, urticaria, pruritus); reduce infusion rate if reactions occur","Clostridioides difficile-associated diarrhea may occur","Use with caution in patients with renal impairment; dosage adjustment recommended for CrCl <30 mL/min not on dialysis","Not recommended in patients on hemodialysis due to limited data"] |
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| Monitor renal function during therapy; no specific fetal monitoring required beyond standard prenatal care. |
| Fertility Effects | No human data; animal studies show no adverse effects on fertility at clinically relevant doses. |