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Expanded broad-spectrum IV antibiotic indicated for adults with cSSSI, cIAI, and CABP due to the indicated pathogens*
(Please see Indications and Important Safety Information)

Clinical Pharmacology Profile of TYGACIL

  • Rapidly and extensively distributed to tissues1
    Tissue concentrations of TYGACIL compared with serum were
    • 38-fold higher in the gallbladder (single-dose study*)
    • 2.3-fold higher in the colon (single-dose study*)
    • 3.7-fold higher in the lung (single-dose study)
    • 0.74-fold lower in skin blister fluid (multiple-dose study in healthy volunteers)
    • 32% higher in the epithelial lining fluid (multiple-dose study following bronchoalveolar lavage)
    • 78-fold higher in the alveolar cells (multiple-dose study following bronchoalveolar lavage)
    *Has not been evaluated in multiple-dose studies.

    Pharmacokinetic data do not necessarily correlate with clinical results.
  • Long half-life1
    • Half-life is 42 hours after multiple doses
  • Low potential for drug interactions
    • Not extensively metabolized1
    • Based on in vitro studies, TYGACIL is not expected to alter the metabolism of drugs metabolized by cytochrome P450 enzymes1
    • TYGACIL is not metabolized by, nor does it induce or inhibit, cytochrome P450 isoenzymes1

Please see the full Prescribing Information for more details on TYGACIL Pharmacokinetics

TYGACIL Update

  • TYGACIL is in the CMS/Joint Commission Quality Measures for non-ICU Bacterial CAP patients

Treatment Guidelines

  • TYGACIL is in the IDSA guidelines for cIAI and SIS guidelines for cIAI and cSSSI5,6
    Learn more about TYGACIL in Treatment Guidelines

Resistance Monitoring Data

The Tigecycline Evaluation and Surveillance Trial (T.E.S.T.) is a comprehensive global surveillance study
initiated in 2004 to evaluate the in vitro activity of tigecycline (TYGACIL) and commonly used antimicrobials
against gram-positive and -negative bacterial pathogens.

Find data on susceptibility to TYGACIL from isolates collected in the United States between 2004 and Present,
and learn more about resistance monitoring data

Next: Clinical Research

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, infection, headache, and abdominal pain
  • 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.