TYGACIL

The mean pharmacokinetic parameters of tigecycline after single and multiple intravenous doses based on pooled data from clinical pharmacology studies are summarized in Table 3. Intravenous infusions of tigecycline were administered over approximately 30 to 60 minutes. Table 3. Mean (CV%) Pharmacokinetic Parameters of Tigecycline Single Dose 100 mg (N=224) Multiple Dose 100 mg initially, followed by 50 mg every 12 hours 50 mg every 12h (N=103) C max (mcg/mL) 30-minute infusion 1.45 (22%) 0.87 (2...

14.1 Complicated Skin and Skin Structure Infections TYGACIL was evaluated in adults for the treatment of complicated skin and skin structure infections (cSSSI) in two randomized, double-blind, active-controlled, multinational, multicenter studies (Studies 1 and 2). These studies compared TYGACIL (100 mg intravenous initial dose followed by 50 mg every 12 hours) with vancomycin (1 g intravenous every 12 hours)/aztreonam (2 g intravenous every 12 hours) for 5 to 14 days. Patients with complicated deep soft tissue infections including wound infections and cellulitis (≥10 cm, requiring surgery/dra...

The following serious adverse reactions are described elsewhere in the labeling:

• All-Cause Mortality [see Boxed Warning and Warnings and Precautions (5.1) ]
• Mortality Imbalance and Lower Cure Rates in Hospital-Acquired Pneumonia [see Warnings and Precautions (5.2) ]
• Anaphylaxis [ Warning and Precautions (5.3) ]
• Hepatic Adverse Effects [ Warnings and Precautions (5.4) ]
• Pancreatitis [ Warnings and Precautions (5.5) ] The most common adverse reactions (incidence >5%) are nausea, vomiting...

TYGACIL 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 TYGACIL-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 TYGACIL-treated patients with ventilator-associated pneumonia. ( 5.1 , ...

7 DRUG INTERACTIONS

• Warfarin : Suitable anticoagulation test should be monitored if TYGACIL is administered to patients receiving warfarin. ( 7.1 )
• Calcineurin Inhibitors : Serum concentrations of calcineurin inhibitors (e.g., tacrolimus, cyclosporine) should be monitored during treatment with TYGACIL due to risk of toxicity. ( 7.2 ) 7.1 Warfarin Prothrombin time or other suitable anticoagulat...