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Tigecycline for Injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections ( 1.1 ) Complicated intra-abdominal infections ( 1.2 ) Community-acquired bacterial pneumonia ( 1.3 ) Limitations of Use : Tigecycline for Injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia. ( 1.4 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tigecycline for Injection and other antibacterial drugs, Tigecycline for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.5 ) 1.1 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 (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. 1.2 Complicated Intra-abdominal Infections Tigecycline for Injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal …

Tigecycline is contraindicated for use in patients who have known hypersensitivity to tigecycline or to any of the excipients. Reactions have included anaphylactic reactions [see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.2 )]. Known hypersensitivity to tigecycline. ( 4 )

All-Cause Mortality : A meta-analysis of Phase 3 and 4 clinical trials demonstrated an increase in all-cause mortality in tigecycline-treated patients compared to controls with a risk difference of 0.6% (95% CI 0.1, 1.2). The cause of this increase has not been established. An increase was also seen in a meta-analysis limited to the approved indications [0.6% (95% CI 0.0, 1.2)]. The greatest difference in mortality was seen in tigecycline-treated patients with ventilator-associated pneumonia. ( 5.1 , 5.2 ) Anaphylactic Reactions : have been reported with tigecycline, and may be life-threatening. Avoid use in patients with known hypersensitivity to tetracyclines. ( 5.3 ) Hepatic Adverse Effects : have been reported with tigecycline. Patients who develop abnormal liver function tests during tigecycline therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy. ( 5.4 ) Pancreatitis : including fatalities, has been reported with tigecycline. If pancreatitis is suspected, then consider stopping tigecycline. ( 5.5 ) Monitoring Blood Coagulation Parameters : Hypofibrinogenemia has been reported with tigecycline. Monitor blood coagulation parameters, including fibrinogen, at baseline and regularly during treatment with tigecycline. ( 5.6 ) Tooth Discoloration and Enamel Hypoplasia : The use of tigecycline during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may …

8.1 Pregnancy Risk Summary Tigecycline, like other tetracycline class antibacterial drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.7 , 5.8 ), Data , and Use in Specific Populations ( 8.4 )] . There are no available data on the risk of major birth defects or miscarriage following the use of tigecycline during pregnancy. Administration of intravenous tigecycline in pregnant rats and rabbits during the period of organogenesis was associated with reduction in fetal weights and an increased incidence of skeletal anomalies (delays in bone …