Clinical cure rates (%) in CABP in clinically evaluable patients (n/N)²⁸

* TYGACIL 100 mg IV initial dose, followed by 50 mg every 12 hours for 7 to 14 days.
† Levofloxacin 500 mg IV every 12 or 24 hours for 7 to 14 days. In one study, a switch to oral levofloxacin 500 mg/day was permitted after at least 3 days for both treatment arms.
Data from two randomized, double-blind, active-controlled, multinational, multicenter studies of 846 patients.
Cure = signs and symptoms of pneumonia improved or resolved at test of cure; chest radiographs improved or were no worse; no further potentially effective antibiotic treatment was necessary for treatment of pneumonia; no worsening or appearance of new signs or symptoms of pneumonia.

TYGACIL—proven efficacy in patients with CABP and common underlying medical conditions²⁸

Sub-group analysis of clinical cure rates in clinically evaluable patients with CABP ^25,28‡§

‡ Two pivotal studies.
§ No statistically significant difference between the two treatment groups.

TYGACIL is indicated for the treatment of adults with CABP caused by the following pathogens¹:

Clinical cure rates in CABP by infecting pathogen in microbiologically evaluable patients^1*

* Two pivotal studies.
† Includes cases of concurrent bacteremia (cure rates of 20/22 [90.9%] versus 13/18 [72.2%] for TYGACIL and levofloxacin, respectively).

TYGACIL efficacy was proven in patients with S. pneumoniae with concurrent bacteremia

TYGACIL—proven efficacy in CABP patients with a higher risk of mortality¹

Post-hoc analysis of clinical cure rates in clinically evaluable patients with CABP based on risk of mortality^1*

* Patients at higher risk of death include patients with any one of the following: ≥50 years of age; PSI score ≥3; or bacteremia due to Streptococcus pneumoniae.
† 95% confidence interval for the treatment difference.
‡ After at least 3 days of intravenous therapy, a switch to oral levofloxacin (500 mg daily) was permitted for both treatment arms in Study 1.

Review patient profiles for examples of how TYGACIL provides effective, simplified management for CABP.¹

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
• 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
• 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.