Tigecycline Use Guidelines

University of Pennsylvania Medical Center Guidelines for Antibiotic Use

Guidelines for the Use of Tigecycline (Tygacil®)

The Antibiotic Subcommittee of the Pharmacy & Therapeutics Committee has reviewed and discussed all of the clinical, pharmacokinetic, drug interaction, and safety data relating to the new glycylcycline antibiotic, tigecycline. One major randomized, multicenter, double-blind, comparative trial demonstrated that tigecycline was as safe and efficacious as vancomycin + aztreonam combination in treating patients with complicated skin and skin-structure infections (cSSSI).¹ Another major randomized, multicenter, double-blind, comparative trial demonstrated that tigecycline was as safe and efficacious as imipenem-cilastatin in treating patients with complicated intra-abdominal infections.² However, six patients in the tigecycline group who presented with intestinal perforations developed sepsis/septic shock (compared with 2 patients in the imipenem-cilastatin group).² Therefore, tigecycline should NOT be used as monotherapy in patients with complicated intra-abdominal infections caused by bowel perforation. Tigecycline has in vitro and in vivo activity against a broad spectrum of bacterial pathogens and no cross resistance has been observed between tigecycline and other antibiotics.³ The most common adverse reactions associated with tigecycline therapy were nausea (30%) and vomiting (20%).³

In order to decrease the risk of treatment failure and preserve tigecycline for treatment of multi-drug resistant gram-negative pathogens, the following are criteria for the use of tigecycline at the Hospital of the University of Pennsylvania:

All use of tigecycline requires ID approval and known susceptibility of the infecting organism to the drug.
Treatment of infections with multi-drug resistant gram-negative organisms in patients with multiple drug allergies, particularly both penicillins and fluoroquinolones.
Tigecycline should NOT be used as monotherapy in patients with complicated intra-abdominal infections caused by bowel perforation or if bowel perforation is a consideration.
Tigecycline should NOT be used as empiric therapy for nosocomial pneumonia due to inactivity of tigecycline against Pseudomonas aeruginosa.
Tigecycline should be used with caution when treating infections other than complicated skin and skin-structure infections and complicated intra-abdominal infections, since the clinical effectiveness of tigecycline has not been determined. The drug should not be used for the treatment of upper or lower tract urinary tract infection because of poor urinary drug concentrations.

Tigecycline dosing:

	Usual Dose	Renal Failure	Severe Hepatic Impairment (Child Pugh C)
Loading Dose	100 mg IV x1	no adjustment needed	100 mg IV x1
Maintenance Dose	50 mg IV q12h	no adjustment needed	25 mg IV q12h

References:

1. Ellis-Grosse EJ, Babinchak T, Dartois N, Rose G, Loh E. The Efficacy and Safety of Tigecycline in the Treatment of Skin and Skin-Structure Infections: Results of 2 Double-Blind Phase 3 Comparison Studies with Vancomycin-Aztreonam. Clinical Infectious Diseases. 2005; 41:S341-53.

2. Babinchak T, Ellis-Grosse E, Dartois N, Rose GM, Loh E. The Efficacy and Safety of Tigecycline for the Treatment of Complicated Intra-Abdominal Infections: Analysis of Pooled Clinical Trial Data. Clinical Infectious Diseases. 2005; 41:S354-67.

3. Tygacil™ [tigecycline] package insert. Philadelphia, PA: Wyeth Pharmaceuticals Inc, June 2005.

Written by Shawn Binkley 7/10/06

Back to Table of Contents