Brand Name
Tygacil
Generic Name
Tigecycline
View Brand Information FDA approval date: June 15, 2008
Classification: Tetracycline-class Antibacterial
Form: Injection
What is Tygacil (Tigecycline)?
Complicated Intra-abdominal Infections Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis , Staphylococcus aureus , Streptococcus anginosus grp. , Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros. Community-Acquired Bacterial Pneumonia Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of community-acquired bacterial pneumonia caused by susceptible isolates of Streptococcus pneumoniae , including cases with concurrent bacteremia, Haemophilus influenzae, and Legionella pneumophila. Limitations of Use Tigecycline for injection is not indicated for the treatment of diabetic foot infections. A clinical trial failed to demonstrate non-inferiority of tigecycline for injection for treatment of diabetic foot infections. Tigecycline for injection is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia. In a comparative clinical trial, greater mortality and decreased efficacy were reported in tigecycline-treated patients [see Warnings and Precautions. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tigecycline and other antibacterial drugs, tigecycline for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to tigecycline. Tigecycline for injection may be initiated as empiric monotherapy before results of these tests are known. Tigecycline for injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections. Complicated Skin and Skin Structure Infections Tigecycline for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of Escherichia coli, Enterococcus faecalis , Staphylococcus aureus , Streptococcus agalactiae, Streptococcus anginosus grp. , Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis.
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Brand Information
Tygacil (TIGECYCLINE)
WARNING: ALL-CAUSE MORTALITY
An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in TYGACIL-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. TYGACIL should be reserved for use in situations when alternative treatments are not suitable
1DOSAGE FORMS AND STRENGTHS
For Injection: Each single-dose 10 mL glass vial contain 50 mg of tigecycline as an orange lyophilized powder for reconstitution.
2CONTRAINDICATIONS
TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline
3ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- All-Cause Mortality
- Mortality Imbalance and Lower Cure Rates in Hospital-Acquired Pneumonia
- Anaphylaxis
- Hepatic Adverse Effects
- Pancreatitis
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, 2514 patients were treated with TYGACIL. TYGACIL was discontinued due to adverse reactions in 7% of patients compared to 6% for all comparators. Table 1 shows the incidence of adverse reactions through test of cure reported in ≥2% of patients in these trials.
In all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4.0% (150/3788) of patients receiving TYGACIL and 3.0% (110/3646) of patients receiving comparator drugs. In a pooled analysis of these trials, based on a random effects model by trial weight, an adjusted risk difference of all-cause mortality was 0.6% (95% CI 0.1, 1.2) between TYGACIL and comparator-treated patients (see
An analysis of mortality in all trials conducted for approved indications - cSSSI, cIAI, and CABP, including post-market trials (one in cSSSI and two in cIAI) - showed an adjusted mortality rate of 2.5% (66/2640) for tigecycline and 1.8% (48/2628) for comparator, respectively. The adjusted risk difference for mortality stratified by trial weight was 0.6% (95% CI 0.0, 1.2).
In comparative clinical studies, infection-related serious adverse reactions were more frequently reported for subjects treated with TYGACIL (7%) versus comparators (6%). Serious adverse reactions of sepsis/septic shock were more frequently reported for subjects treated with TYGACIL (2%) versus comparators (1%). Due to baseline differences between treatment groups in this subset of patients, the relationship of this outcome to treatment cannot be established
The most common adverse reactions were nausea and vomiting which generally occurred during the first 1 – 2 days of therapy. The majority of cases of nausea and vomiting associated with TYGACIL and comparators were either mild or moderate in severity. In patients treated with TYGACIL, nausea incidence was 26% (17% mild, 8% moderate, 1% severe) and vomiting incidence was 18% (11% mild, 6% moderate, 1% severe).
In patients treated for complicated skin and skin structure infections (cSSSI), nausea incidence was 35% for TYGACIL and 9% for vancomycin/aztreonam; vomiting incidence was 20% for TYGACIL and 4% for vancomycin/aztreonam. In patients treated for complicated intra-abdominal infections (cIAI), nausea incidence was 25% for TYGACIL and 21% for imipenem/cilastatin; vomiting incidence was 20% for TYGACIL and 15% for imipenem/cilastatin. In patients treated for community-acquired bacterial pneumonia (CABP), nausea incidence was 24% for TYGACIL and 8% for levofloxacin; vomiting incidence was 16% for TYGACIL and 6% for levofloxacin.
Discontinuation from TYGACIL was most frequently associated with nausea (1%) and vomiting (1%). For comparators, discontinuation was most frequently associated with nausea (<1%).
The following adverse reactions were reported (<2%) in patients receiving TYGACIL in clinical studies:
Body as a Whole: injection site inflammation, injection site pain, injection site reaction, septic shock, allergic reaction, chills, injection site edema, injection site phlebitis
Cardiovascular System: thrombophlebitis
Digestive System: anorexia, jaundice, abnormal stools
Metabolic/Nutritional System: increased creatinine, hypocalcemia, hypoglycemia
Special Senses: taste perversion
Hemic and Lymphatic System: prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia
Skin and Appendages: pruritus
Urogenital System: vaginal moniliasis, vaginitis, leukorrhea
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of TYGACIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.
- anaphylactic reactions
- acute pancreatitis
- hepatic cholestasis, and jaundice
- severe skin reactions, including Stevens-Johnson Syndrome
- symptomatic hypoglycemia in patients with and without diabetes mellitus
- hypofibrinogenemia
4OVERDOSAGE
No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of TYGACIL at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting. Tigecycline is not removed in significant quantities by hemodialysis.
5DESCRIPTION
TYGACIL (tigecycline) is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline is (4
The following represents the chemical structure of tigecycline:
TYGACIL is an orange lyophilized powder or cake. Each TYGACIL single-dose 10 mL vial contains 50 mg tigecycline lyophilized powder for reconstitution for intravenous infusion and 100 mg of lactose monohydrate. The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide. The product does not contain preservatives.
6HOW SUPPLIED/STORAGE AND HANDLING
TYGACIL (tigecycline) for injection is supplied in a single-dose 10 mL glass vial, containing 50 mg tigecycline lyophilized powder for reconstitution.
Supplied:
7PRINCIPAL DISPLAY PANEL - 50 mg Vial Label
NDC 0008-4990-19
Single-dose Vial
Tygacil
(tigecycline)
for injection
(tigecycline)
for injection
50 mg
tigecycline per vial
8PRINCIPAL DISPLAY PANEL - 50 mg Vial Carton
10 Single-dose Vials
NDC 0008-4990-20
Rx only
Tygacil
(tigecycline)
for injection
(tigecycline)
for injection
50 mg
tigecycline per vial
Pfizer Hospital
RECONSTITUTED SOLUTION
MUST BE FURTHER DILUTED
FOR I.V. INFUSION
MUST BE FURTHER DILUTED
FOR I.V. INFUSION
