Last reviewed 2026-04-20 · How we verify

Vibativ (TELAVANCIN HYDROCHLORIDE)

Telavancin is an antibacterial drug [see Clinical Pharmacology (12.4)].

At a glance

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

• nausea
• vomiting
• diarrhea
• rigors
• decreased appetite
• taste disturbance
• foamy urine

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)
• Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (PHASE3)
• Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (PHASE3)

Patents

Primary sources

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Competitive intelligence

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