Increased Mortality; Nephrotoxicity; Fetal Risk

Increased Mortality

• 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

• Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients [see Warnings and Precautions (5.3)].
  
  

Fetal Risk

• Women of childbearing potential should have a serum pregnancy test prior to administration of telavancin.
• Avoid use of telavancin during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus.
• Adverse developmental outcomes observed in 3 animal species at clinically relevant doses raise concerns about potential aderse developmental outcomes in humans. 
• 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)].