Tigecycline

FDA approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP); it is not approved for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia

Increase in all-cause mortality reported in tigecycline treated patients versus comparator-treated patients; generally, deaths were the result of worsening infection, complications of infection or underlying co-morbidities; therapy should be reserved for use in situations when alternative treatments are not suitable

A trial of patients with hospital-acquired, including ventilator-associated, pneumonia failed to demonstrate drug efficacy with lower cure rates in hospital-acquired pneumonia

Anaphylactic reactions reported with nearly all antibacterial agents and may be life-threatening; tigecycline is structurally similar to tetracycline-class antibacterial drugs and should be avoided in patients with known hypersensitivity to tetracycline-class antibacterial drugs

Monotherapy should be avoided in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation

The drug is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse effects, including photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia)

Prescribing therapy in absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

Increases in total bilirubin concentration, prothrombin time and transaminases reported in patients treated with tigecycline; caution in severe hepatic impairment (reduce dose); patients who develop abnormal liver function tests during therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy; hepatic dysfunction may occur after drug has been discontinued

Hypofibrinogenemia reported; obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment

Avoid use in patients with known hypersensitivity to tetracyclines

May have adverse effects similar to those of tetracyclines (eg, photosensitivity, pseudotumor cerebri, antianabolic action)

Pancreatitis, including fatalities, reported; if pancreatitis suspected, consider stopping treatment; diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis; cases reported in patients without known risk factors for pancreatitis; patients usually improve after therapy discontinuation; consider cessation of treatment in cases suspected of having developed pancreatitis