Tygacil Special Precautions

Caution should be exercised when considering tigecycline monotherapy in patients with cIAI secondary to clinically apparent intestinal perforation. In phase 3 cIAI studies (n=1642), 6 patients treated with tigecycline and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/septic shock. The 6 patients treated with tigecycline had higher APACHE II scores (median=13) versus the 2 patients treated with imipenem/cilastatin (APACHE II scores=4 and 6). Due to differences in baseline APACHE II scores between treatment groups and small overall numbers, the relationship of this outcome to treatment cannot be established.
Isolated cases of significant hepatic dysfunction and hepatic failure have been reported in patients being treated with tigecycline.
Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: Photosensitivity, pseudotumor cerebri, pancreatitis and anti-anabolic action (which has led to increased BUN, azotemia, acidosis and hyperphosphatemia).
Acute pancreatitis, which can be fatal, has occurred (frequency: uncommon) in association with tigecycline treatment. (See Adverse Reactions.) The diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs or laboratory abnormalities suggestive of acute pancreatitis. Cases have been reported in patients without known risk factors for pancreatitis. Patients usually improve after tigecycline discontinuation. Consideration should be given to the cessation of the treatment with tigecycline in cases suspected of having developed pancreatitis.
The safety and efficacy of tigecycline in patients with hospital-acquired pneumonia have not been established. In a study of patients with hospital-acquired pneumonia, patients were randomized to receive tigecycline (100 mg initially, then 50 mg every 12 hrs) or a comparator. In addition, patients were allowed to receive specified adjunctive therapies. The subgroup of patients with ventilator-associated pneumonia who received tigecycline had lower cure rates (47.9% vs 70.1% for the clinically evaluable population) and greater mortality [25/131 (19.1%) vs 15/122 (12.3%)] than the comparator. Of those patients with ventilator-associated pneumonia and bacteremia at baseline, those who received tigecycline had greater mortality [9/18 (50%) vs 1/13 (7.7%)] than the comparator.
As with other antibiotic preparations, use of Tygacil may result in overgrowth of nonsusceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken.
Abuse and Dependence: Drug abuse and dependence have not been demonstrated and are unlikely.
Effects on the Ability to Drive or Operate Machinery: Tigecycline can cause dizziness (see Adverse Reactions) which may impair the ability to drive and/or operate machinery.
Use in Pregnancy: Tigecycline may cause fetal harm when administered to a pregnant woman. Results of animal studies indicate that tigecycline crosses the placenta and is found in fetal tissues.
There are no adequate and well-controlled studies of tigecycline in pregnant women. Tigecycline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Tigecycline has not been studied for use during labor and delivery.
Use in Lactation: It is not known whether Tygacil is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tigecycline is administered to a nursing woman.
Use in Children: Safety and effectiveness in patients <18 years have not been established. Therefore, use in patients <18 years is not recommended.
Use in the Elderly: Of the total number of subjects who received tigecycline in phase 3 clinical studies (n=2514), 664 were ≥65 years, while 228 were ≥75 years. No unexpected overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity to adverse events of some older individuals cannot be ruled out.