Incresaed Mortality; Nephrotoxicity; Fetal Risk
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)].
- 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)].
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Have a pregnancy test prior to administration of drug.
- If benefit outweighs risk and this drug is administered during pregnancy, there is a pregnancy registry that monitors pregnancy outcomes in women exposed to telavancin during pregnancy. Physicians are encouraged to register pregnant patients or pregnant women may enroll themselves in the pregnancy registry by calling 1-888-658-4228.
Patient Counseling Information