Empiric treatment of serious infections in the hospital is one of today’s most formidable medical challenges.2,3 Here are some statistics on the ever-growing burden of infectious disease in hospitals and in our society:
- In the United States, hospital-acquired infections alone afflict nearly
2 million patients and kill approximately 90,000 people annually, more than diabetes or influenza/pneumonia.4,5 - About 70% of these hospital-acquired infections are resistant to at least one drug.4
- Nosocomial infections cost U.S. society between $4 billion and $5 billion annually.6
- The focus on infections has increased as more and more patients admitted to hospitals now present with antibiotic-resistant bacteria acquired in the community, such as certain strains of methicillin-resistant Staphylococcus aureus (MRSA). MRSA was previously found primarily in hospitals and other health care settings.7,8
- Studies suggest that there is a substantial increase in mortality, morbidity, and cost for patients with antibiotic-resistant versus susceptible infections.9,10,11,12
- Multidrug-resistant pathogens are more likely to require longer hospital stays and treatment with second- or third-choice drugs.4
- Infections originating from surgery in the United States resulted in a median hospitalization cost of $7,531 for each infected patient during the 1990s.13
Complicated Intra-abdominal Infections (cIAI)
- Intra-abdominal infections can be difficult to treat, with mortality rates ranging from 3.5% in patients with early infection following a penetrating abdominal trauma to over 60% in patients with well-established infection coupled with secondary organ failure.14
- Strains of vancomycin-resistant enterococci have become an important cause of illness and sometimes death.15
Complicated Skin and Skin Structure Infections (cSSSI)
- Nearly 60% of hospital-acquired Staphylococcus aureus infections in intensive care units reported to the Centers for Disease Control are methicillin-resistant Staphylococcus aureus (MRSA).16
- MRSA has been recognized as a major nosocomial (hospital-acquired) pathogen that causes approximately 21% of skin infections and 28% of surgical wound infections.17
- For the patient, the potential impact of MRSA includes increased morbidity and mortality, slower response to therapy and elevated risk of therapeutic failure, extra procedures and treatments (such as surgical wound drainage), longer hospital stays, more missed workdays, delay in return to usual activities, and reduced quality of life.18
- Within hospitals, MRSA may lead to increased cost of infection control, increased laboratory use for surveillance and screening, use of broader-spectrum empirical therapy, longer hospital stays, and use of costlier therapies.18
- S.aureus was the most prevalent species isolated from inpatient specimens (18.8%) and the second most prevalent species isolated from outpatient specimens (14.9%)19
MRSA rates around the country19
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 only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, and Bacteroides fragilis
- Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros
Important Safety Information
- 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
- Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening
- TYGACIL is contraindicated in patients with known hypersensitivity to tigecycline
- TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics
- Glycylcycline class antibiotics are 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
- The safety and efficacy of TYGACIL in patients with hospital-acquired pneumonia have not been established
- In clinical trials, the most common treatment-emergent adverse events in patients treated with TYGACIL were nausea (29.5%) and vomiting (19.7%)
- TYGACIL may cause fetal harm when administered to a pregnant woman
- The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established
- 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
- Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective
- 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
- Prothrombin time or other suitable anticoagulant test should be monitored if TYGACIL is administered with warfarin
- Monotherapy should be used with caution in patients with clinically apparent intestinal perforation
- In patients with severe hepatic impairment (Child Pugh C), the initial dose of TYGACIL should be 100 mg followed by 25 mg every 12 hours. Patients should be treated with caution and monitored for treatment response
- The following drugs should not be administered simultaneously through the same Y‑site as TYGACIL: amphotericin B and diazepam
Please see Prescribing Information
205930-01