Risk Evaluation and Mitigation Strategies (REMS) Summary

Goal of the Vibativ (telavancin) Injection REMS Program

The goal of the Vibativ REMS is to mitigate the risks of:

• mortality in patients with pre-existing creatinine clearance of ≤50 mL/min being treated for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) by informing healthcare providers about this risk

• unintended exposure of pregnant women to Vibativ by:
- informing healthcare providers and patients of the potential risk of fetal developmental toxicity if women are exposed to Vibativ while pregnant
- informing healthcare providers that a serum pregnancy test should be performed before initiating therapy with Vibativ in females of reproductive potential
- informing healthcare providers that females of reproductive potential, including those being treated in the outpatient setting, should be counseled about pregnancy prevention and use of effective contraception during Vibativ use

REMS Elements

• Medication Guide

• Communication Plan

Open the Full REMS Notification

REMS Summary of Terms