VIBATIV
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIBATIV (VIBATIV).
Lipoglycopeptide antibiotic that inhibits cell wall synthesis by binding to the D-Ala-D-Ala terminus of peptidoglycan precursors, blocking transglycosylation and transpeptidation. Also disrupts membrane potential and increases membrane permeability.
| Metabolism | Not significantly metabolized. Eliminated primarily unchanged via renal excretion (glomerular filtration and active tubular secretion). No major CYP-mediated metabolism. |
| Excretion | Primarily renal excretion as unchanged drug (approximately 93% of dose recovered in urine; <5% in feces). |
| Half-life | Terminal elimination half-life is approximately 177 hours (7.4 days), supporting once-daily dosing. |
| Protein binding | 90–93% bound to human plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 0.12–0.16 L/kg, indicating distribution mainly into extracellular fluid. |
| Bioavailability | Bioavailability is 100% for intravenous administration; no oral formulation available. |
| Onset of Action | Intravenous: Not applicable; no immediate clinical effect; bacteriostatic activity requires time to inhibit cell wall synthesis. |
| Duration of Action | Duration of antimicrobial effect persists for the dosing interval (24 hours) due to long half-life; post-antibiotic effect observed. |
10 mg/kg intravenously once every 24 hours, infused over 60 minutes for 7 to 14 days.
| Dosage form | POWDER |
| Renal impairment | CrCl ≥50 mL/min: 10 mg/kg every 24h; CrCl 30-49 mL/min: 10 mg/kg every 48h; CrCl 10-29 mL/min: 10 mg/kg every 72h; CrCl <10 mL/min: not recommended (no data). |
| Liver impairment | No dosage adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B); not studied in severe impairment (Child-Pugh C). |
| Pediatric use | Safety and effectiveness in pediatric patients have not been established. |
| Geriatric use | No specific dose adjustment except based on renal function; consider age-related decline in CrCl. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VIBATIV (VIBATIV).
| Breastfeeding | It is unknown whether telavancin is excreted in human breast milk. However, telavancin is excreted in the milk of lactating rats. The M/P ratio is not established in humans. Because many drugs are excreted in human milk, caution should be exercised when VIBATIV is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VIBATIV and any potential adverse effects on the breastfed child. |
| Teratogenic Risk | VIBATIV (telavancin) is classified as Pregnancy Category C. Animal studies have shown developmental toxicity including reduced fetal weights and increased skeletal variations at doses similar to human exposures. There are no adequate and well-controlled studies in pregnant women. Telavancin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The drug crosses the placenta. Particular caution is warranted in the first trimester due to potential teratogenicity. |
■ FDA Black Box Warning
WARNING: INCREASED MORTALITY IN HABP/VABP COMPARED TO VANCOMYCIN. In a clinical trial of HABP/VABP, all-cause mortality was higher in patients treated with VIBATIV (21.5%) versus vancomycin (16.6%). Use only when no suitable alternative treatment is available.
| Serious Effects |
Hypersensitivity to telavancin or any component of the formulation. Known hypersensitivity to other glycopeptide antibiotics (e.g., vancomycin) may cross-react.
| Precautions | Nephrotoxicity: Monitor renal function, especially in patients with preexisting renal impairment or those receiving concomitant nephrotoxic agents. QT prolongation: Avoid in patients with prolonged QT interval or receiving other QT-prolonging drugs. Red man syndrome: Infusion-related reactions may occur; slow infusion rate if needed. Clostridioides difficile-associated diarrhea: Consider in patients presenting with diarrhea. Fetal harm: May cause fetal harm based on animal data; use during pregnancy only if potential benefit outweighs risk. |
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| Fetal Monitoring | Monitor renal function closely due to nephrotoxicity potential; telavancin is primarily excreted renally. Assess renal function (serum creatinine, BUN, urine output) at baseline and at least every 48 hours during therapy. Monitor for signs of fetal distress if used in pregnancy; consider ultrasound assessment of fetal growth and amniotic fluid volume if prolonged treatment. Also monitor coagulation parameters (PT, aPTT) as telavancin may interfere with coagulation tests. Monitor for infusion-related reactions and QTc prolongation via ECG. |
| Fertility Effects | Telavancin had no adverse effects on fertility or reproductive performance in male and female rats at doses up to 150 mg/kg/day (approximately 0.6 times the human dose based on AUC). There are no human data on fertility effects. The potential for telavancin to impair human fertility is unknown. |