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  1. Tygacil® (tigecycline) Prescribing Information, Pfizer Pharmaceuticals Inc.
  2. Archer GL, Polk RE. Treatment and prophylaxis of bacterial infections. In: Braunwald E, Fauci AS, Kasper DL, et al, eds. Harrison’s Principles of Internal Medicine. 15th ed. Vol 1. New York, NY: McGraw-Hill; 2001:867-882.
  3. Masterton R, Drusano G, Paterson DL, et al. Appropriate antimicrobial treatment in nosocomial infections—the clinical challenges. J Hosp Infect. 2003;55:1-12.
  4. Centers for Disease Control and Prevention (CDC). Prevent antimicrobial resistance in healthcare settings. http://www.cdc.gov/drugresistance/healthcare/problem.htm. Accessed April 8, 2005.
  5. Centers for Disease Control and Prevention (CDC). Deaths — leading causes. http://www.cdc.gov/nchs/fastats/lcod.htm. Accessed April 8, 2005.
  6. Martone WJ, Jarvis WR, Culver DH, et al. Incidence and nature of endemic and epidemic nosocomial infections. In: Bennett JV, Brachman PS, eds. Endemic and Epidemic Hospital Infections. 3rd ed. Boston, MA: Little, Brown, and Company; 1992:577-596.
  7. Georgia Epidemiology Report. Community-associated methicillin resistant Staphylococcus aureus (MRSA). June 2004;20:1-4.
  8. Centers for Disease Control and Prevention. National Nosocomial Infections Surveillance (NNIS) system report, data summary from January 1992-June 2001, issued August 2001. Am J Infect Control. 2001;29:404-421.
  9. Kollef MH, Ward S, Sherman G, et al. Inadequate treatment of nosocomial infections is associated with certain empiric antibiotic choices. Crit Care Med. 2000;28:3456-3464.
  10. Cosgrove SE, Kaye KS, Eliopoulous GM, et al. Health and economic outcomes of the emergence of third-generation cephalosporin resistance in Enterobacter species. Arch Intern Med. 2002;162:185-190.
  11. Carmeli Y, Troillet N, Karchmer AW, et al. Health and economic outcomes of antibiotic resistance in Pseudomonas aeruginosa. Arch Intern Med. 1999;159:1127-1132.
  12. Carmeli Y, Eliopoulos G, Mozaffari E, et al. Health and economic outcomes of vancomycin-resistant enterococci. Arch Intern Med. 2002;162:2223-2228.
  13. Kirkland KB, Briggs JP, Trivette SL, et al. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999;20:725-730.
  14. Levison ME, Bush LM. Peritonitis and other intra-abdominal infections. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Disease. 5th ed. Philadelphia, PA: Churchill Livingstone; 2000:821-856.
  15. Morris JG, Shay DK, Hebden JN, et al. Enterococci resistant to multiple antimicrobial agents, including vancomycin: establishment of endemicity in a university medical center. Ann Intern Med [serial online]. 1995;123:250-259. http://www.annals.org/cgi/content/full/123/4/250. Accessed April 19, 2007.
  16. Kronemyer B. MRSA incidence on the rise. Infectious Disease News. May 2004. http://www.infectiousdiseasenews.com/200405/mrsa.asp. Accessed September 28, 2004.
  17. Baquero F. Gram-positive resistance: challenge for the development of new antibiotics. J Antimicrob Chemother. 1997;39(suppl A):1-60.
  18. Nathwani D. Impact of methicillin-resistant Staphylococcus aureus infections on key health economic outcomes: does reducing the length of hospital stay matter? J Antimicrob Chemother. 2003;51(suppl S2):ii37-ii44.
  19. Styers D, Sheehan DJ, Hogan P, et al. Laboratory-based surveillance of current antimicrobial resistance patterns and trends among Staphylococcus aureus: 2005 status in the United States. Ann Clin Microbiol Antimicrob. 2006;5:2.
  20. Testa RT, Petersen PJ, Jacobus NV, et al. In vitro and in vivo antibacterial activities of the glycylcyclines, a new class of semisynthetic tetracyclines. Antimicrob Agents Chemother. 1993;37:2270-2277.
  21. Garrison MW, Neumiller JJ, Setter SM. Tigecycline: an investigational glycylcycline antimicrobial with activity against resistant gram-positive organisms. Clin Ther. 2005;27:12-22.
  22. Bergeron J, Ammirati M, Danley D, et al. Glycylcyclines bind to the high-affinity tetracycline ribosomal binding site and evade Tet(M)- and Tet(O)-mediated ribosomal protection. Antimicrob Agents Chemother. 1996;40:2226-2228.
  23. Bauer G, Berens C, Projan SJ, et al. Comparison of tetracycline and tigecycline binding to ribosomes mapped by dimethylsulphate and drug-directed Fe2+ cleavage of 16S rRNA. J Antimicrob Chemother. 2004;53:592-599.
  24. Bradford PA. Tigecycline: a first in class glycylcycline. Clinical Microbiology Newsletter. 2004;26:163-168.
  25. Data on file, Pfizer Pharmaceuticals Inc.
  26. Ellis-Grosse EJ, Babinchak T, Dartois N, et al. 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. Clin Infect Dis. 2005:41(suppl 5):S341-S353.
  27. Babinchak T, Ellis-Grosse EJ, Dartois N, et al. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections: analysis of pooled clinical trial data. Clin Infect Dis. 2005;41(suppl 5):S354-S367.
  28. Tanaseanu C, Bergallo C, Teglia O, et al, for the 308 Study Group and 313 Study Group. Integrated results of 2 phase 3 studies comparing tigecycline and levofloxacin in community-acquired pneumonia. Diagn Microbiol Infect Dis. 2008;61:329-338.
  29. Waites KB, Duffy LB, Dowzicky MJ. Antimicrobial susceptibility among pathogens collected from hospitalized patients in the United States and in vitro activity of tigecycline, a new glycylcycline antimicrobial. Antimicrob Agents Chemother. 2006;50:3479-3484.
  30. Hoban DJ, Bouchillon SK, Johnson BM, et al. In vitro activity of tigecycline against 6792 gram-negative and gram-positive clinical isolates from the global Tigecycline Evaluation and Surveillance Trial (TEST program, 2004). Diagn Microbiol Infect Dis. 2005;52:215-227.
  31. T.E.S.T. Web site. http://www.testsurveillance.com. Accessed May 8, 2007.

Indications and Important Safety Information

Indications

TYGACIL® (tigecycline) is indicated for the treatment of adults with:

  • Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis
  • Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus,
    S. intermedius    , and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros
  • Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila

Important Safety Information

  • TYGACIL is contraindicated in patients with known hypersensitivity to tigecycline
  • Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening. TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline-class antibiotics
  • Isolated cases of significant hepatic dysfunction and hepatic failure have been reported in patients being treated with tigecycline. Some of these patients were receiving multiple concomitant medications. Patients who develop abnormal liver function tests during tigecycline therapy should be monitored for evidence of worsening hepatic function. Adverse events may occur after the drug has been discontinued
  • The safety and efficacy of TYGACIL in patients with hospital-acquired pneumonia have not been established
  • An increase in all-cause mortality has been observed across phase 3 and 4 clinical studies in TYGACIL-treated patients versus comparator-treated patients. The cause of this increase has not been established. This increase in all-cause mortality should be considered when selecting among treatment options
  • TYGACIL may cause fetal harm when administered to a pregnant woman
  • The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated
  • Acute pancreatitis, including fatal cases, has occurred in association with tigecycline treatment. Consideration should be given to the cessation of the treatment with tigecycline in cases suspected of having developed pancreatitis
  • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis
  • Monotherapy should be used with caution in patients with clinically apparent intestinal perforation
  • TYGACIL is structurally similar to tetracycline-class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria. As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi
  • The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, abdominal pain, headache, and increased SGPT
  • Prothrombin time or other suitable anticoagulant test should be monitored if TYGACIL is administered with warfarin
  • Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective
  • The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established

Please see full Prescribing Information.