Dosing and uses of Vibativ (telavancin)
Adult dosage forms and strengths
injection
- 250mg/vial
- 750mg/vial
Skin & Skin Structure Infections
Indicated for skin and skin structure infections caused by Gram-positive bacteria including Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S anginosus, S intermedius, and S constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only)
10 mg/kg IV q24hr for 7-14 days; infuse over 1 hr
Pneumonia
Indicated for hospital-acquired, including ventilator-associated bacterial pneumonia caused by susceptible isolates of Staphylococcus aureus (including methacillin-relesistant and vancomycin-intermediate strains) when alternative treatments are not suitable
10 mg/kg IV q24hr for 7-21 days; infuse over 1 hr
Dosing Considerations
Pneumonia: Approved only to treat Staphylococcus aureus, not other pneumonia-causing bacteria
Renal Impairment
CrCl 30-50 mL/minute: 7.5 mg/kg IV q24hr
CrCl 10-29 mL/minute: 10 mg/kg IV q48hr
Pediatric dosage forms and strengths
Safety and efficacy not established
Vibativ (telavancin) adverse (side) effects
>10%
Taste disturbance
Nausea
Vomiting
Foamy urine
1-10%
Diarrhea
Dizziness
Rigors
Pruritus
Rash
Warnings
Black box warnings
Renal impairment
- Increased mortality compared with vancomycin in patients with pre-existing moderate/severe renal impairment (CrCl 50 mL/min or less) who were treated for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia
- Use with pre-existing moderate/severe renal impairment should be considered only when the anticipated benefit to the patient outweighs the potential risk
- Nephrotoxicity: New onset or worsening renal impairment has occurred; monitor renal function in all patients
Pregnancy
- Women of childbearing potential should have a serum pregnancy test prior to administration
- Avoid during pregnancy unless potential benefit to the patient outweighs potential risk to the fetus
- Adverse developmental outcomes observed in 3 animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans
Contraindications
Hypersensitivity
Use of intravenous unfractionated heparin sodium
Cautions
New onset or worsening renal impairment has been reported (monitor renal function)
Efficacy decreased with moderate-to-severe baseline renal impairment (ie, CrCl <50 mL/min) for skin and skin structure infections
Administer over at least 1 hr to minimize infusion-related adverse reactions
Clostridium difficile-associated diarrhea may occur
May prolong QTc interval; coadministration with other drugs that prolong QTc interval (eg, phenothiazine, TCAs, macrolide antibiotics, class I and III antiarrhythmic agents) increased risk for life-threatening arrhythmias
Interferes with coagulation tests including PT, INR, and APT, but does not interfere with coagulation
Pregnancy and lactation
Pregnancy category: C
Women of childbearing potential should have serum pregnancy test before administration
Adverse developmental outcomes observed in 3 animal species at clinically relevant doses raise concerns about potential for human fetal harm
Lactation: Unknown if excreted in breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Vibativ (telavancin)
Mechanism of action
Lipoglycopeptide antibiotic that is a synthetic derivative of vancomycin
Inhibits bacterial cell wall synthesis by interfering with polymerization and cross-linking of peptidoglycan
Unlike vancomycin, telavancin also depolarizes the bacterial cell membrane and disrupts its functional integrity
Absorption
Poor oral absorption
Distribution
Protein Bound: 90%
Vd: 133-145 mL/kg
Metabolism
Metabolic pathway not yet identified; not metabolized by CYP450 isoenzymes
Elimination
Half-life: 8 hr
Clearance: 13.1-13.9 mL/hr/kg
Excretion: 75% urine; <1% feces
Administration
IV Compatibility
Data limited
Do not add other drugs or infuse simultaneously through same IV line
Flush IV line before and after infusion for sequential infusion of additional medications
IV Preparation
250 mg vial reconstitution
- Add 15 mL of D5W, SWI, or NS
- Resultant solution concentration 15 mg/mL (total volume approximately 17 mL)
750 mg vial reconstitution
- Add 45 mL of D5W, SWI, or NS
- Resultant solution concentration 15 mg/mL (total volume approximately 50 mL)
Further dilution
- Solutions for further dilution before infusion include: D5W, NS, lactated Ringer's injection
- Doses of 150-800 mg: dilute further in 100-250 mL of IV solution
- Doses <150 mg or >800 mg: dilute further to final concentration of 0.6-8 mg/mL
IV Administration
Intermittent infusion over 60 min
Stability
No preservative or bacteriostatic agent in product
Reconstituted solution or further diluted
- Stored at room temp: Use within 4 hr
- Stored refrigerated: Use within 72 hr
