TYGACIL has proven clinical efficacy as monotherapy in both complicated skin and skin structure infections (cSSSI) and complicated intra-abdominal infections (cIAI).1
Hypothetical Patient Profile 1: cSSSI
Not actual photograph
of this case.
Male: 85-year-old nursing home resident
Presentation: Febrile, decubitis ulcer with foul-smelling and purulent drainage. Wound has failed to heal
despite several antibiotic regimens
Dx: Labs confirm MRSA and Bacteroides fragilis
Hx: Nursing home residence, renal failure, taking several medications
Tx: Broad-spectrum antibiotic therapy
Rationale for TYGACIL: Empiric broad-spectrum single-agent antibiotic therapy for cSSSI covering many gram positives, gram negatives, and anaerobes, including MRSA and B. fragilis. TYGACIL does not require dosage adjustment for renal impairment
Hypothetical Patient Profile 2: cSSSI
Not actual photograph
of this case.
Female: 46 years old
Presentation: 4-day-old painful, rapidly spreading rash covering the left ankle, accompanied by fever, chills,
and general malaise; patient reluctant to see physician
Dx: Cellulitis
Hx: Treated with oral quinolone 4 months ago for unrelated illness. Goes to the gym 4 days per week. Patient
is allergic to penicillin.
Tx: Empiric antibiotic therapy
Rationale for TYGACIL: Empiric broad-spectrum single-agent antibiotic therapy for cSSSI covering MRSA; appropriate for patients with penicillin allergy
Hypothetical Patient Profile 3: cIAI
Not actual photograph
of this case.
Female: 84 years old
Presentation: Severe fever, vomiting, 3-4–day history of abdominal discomfort
Dx: Intestinal perforation with peritonitis secondary to severe diverticular disease
Hx: Multiple medications to manage CAD, osteoarthritis, and anemia; past cholecystectomy; high APACHE II
scores; not responding to multiple antibiotic regimen
Tx: Laparotomy, IV antibiotics
Rationale for TYGACIL: Empiric broad-spectrum antibiotic therapy for cIAI, with low potential for drug interactions and appropriate for patients with multiple comorbidities
Hypothetical Patient Profile 4: cIAI
Not actual photograph
of this case.
Male: 29 years old
Presentation: Severe fever, 4-day history of acute right lower quadrant abdominal pain, vomiting
Dx: Appendicitis with possible perforation; blood cultures reveal Klebsiella pneumoniae, Escherichia
coli, and Enterococcus faecalis
Hx: Insulin-dependent diabetes, obesity
Tx: Surgery; IV antibiotic initiated
Rationale for TYGACIL: Empiric broad-spectrum monotherapy for cIAI; low potential for drug interactions
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
- 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.
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