Last reviewed · How we verify
Vibativ (TELAVANCIN)
Vibativ works by binding to the bacterial cell wall, disrupting its synthesis and ultimately leading to cell death.
Vibativ (telavancin) is a lipoglycopeptide antibacterial small molecule developed by Theravance Biopharma and currently owned by Cumberland. It is used to treat various bacterial infections, including pneumonia and complicated skin and skin structure infections caused by Staphylococcus aureus, Enterococcus faecalis, and other bacteria. Vibativ was FDA-approved in 2009 and remains a patented product with no generic manufacturers. Key safety considerations include its potential to cause nephrotoxicity and neurotoxicity. It has a half-life of 6.7 hours.
At a glance
| Generic name | TELAVANCIN |
|---|---|
| Sponsor | Cumberland |
| Drug class | Lipoglycopeptide Antibacterial |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2009 |
Mechanism of action
Telavancin is an antibacterial drug [see Clinical Pharmacology (12.4)].
Approved indications
- Bacterial pneumonia
- Complicated Skin and Skin Structure Enterococcus Faecalis Infection
- Complicated Skin and Skin Structure Infection
- Complicated Skin and Skin Structure Staphylococcus Aureus Infection
- Complicated Skin and Skin Structure Streptococcus Agalactiae Infection
- Complicated Skin and Skin Structure Streptococcus Pyogenes Infection
- Pneumonia due to Staphylococcus aureus
Boxed warnings
- WARNING: INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, POTENTIAL ADVERSE DEVELOPMENTAL OUTCOMES Patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk [see Warnings and Precautions ( 5.1 , 8.4 )]. Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients [see Warnings and Precautions ( 5.3 )] . Embryofetal Toxicity: VIBATIV may cause fetal harm. In animal reproduction studies, adverse developmental outcomes were observed in 3 animal species at clinically relevant doses. Verify pregnancy status in females of reproductive potential prior to initiating VIBATIV. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VIBATIV and for 2 days after the final dose [see Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 , 8.3 )]. WARNING: INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, and EMBRYO-FETAL TOXICITY See full prescribing information for the complete boxed warning Patients with pre-existing moderate/severe renal impairment (CrCl≤50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk. ( 5.1 , 8.4 ) Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients. ( 5.3 ) Embryo-Fetal Toxicity: VIBATIV may cause fetal harm. In animal reproduction studies, adverse developmental outcomes were observed in 3 animal species at clinically relevant doses. Verify pregnancy status prior to initiating treatment and advise females of reproductive potential to use effective contraception ( 5.4 , 8.1 , 8.3 ).
Common side effects
- Taste disturbance
- Nausea
- Vomiting
- Foamy urine
- Diarrhea
- Renal failure
- Nephrotoxicity
- Rigors
- Decreased appetite
- Electrocardiogram QTc interval prolonged
- Septic shock
- Multi-organ failure
Drug interactions
- High Risk QT Prolonging Agents
Key clinical trials
- Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular Drainage (PHASE4)
- Telavancin Pediatric PK Study (Ages >12 Months to 17 Years) (PHASE1)
- VIBATIV Pregnancy Registry
- A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial (PHASE3)
- Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients (PHASE2)
- Telavancin Pharmacokinetics in Cystic Fibrosis Patients (PHASE4)
- Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (PHASE2)
- Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vibativ CI brief — competitive landscape report
- Vibativ updates RSS · CI watch RSS
- Cumberland portfolio CI