Tygacil Special Precautions

An increase in all-cause mortality has been observed across Phase 3 and 4 clinical trials in tigecycline-treated subjects versus comparator-treated subjects. In a pooled analysis of all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4.0% (150/3788) of subjects receiving tigecycline and 3.0% (110/3646) of subjects receiving comparator drugs resulting in an unadjusted risk difference of 0.9% (95% CI 0.1, 1.8). 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 tigecycline and comparator-treated subjects. The cause of this increase has not been established. This increase in all-cause mortality should be considered when selecting among treatment options (see Adverse Reactions).
Anaphylactic reaction/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening.
Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics. Therefore, tigecycline should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics.
Results of studies in rats with tigecycline have shown bone discoloration. Tigecycline may be associated with permanent tooth discoloration in humans during tooth development.
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of any antibacterial agent.
Caution should be exercised when considering tigecycline monotherapy in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation. In Phase 3 and 4 cIAI studies (n=2775), 140/1382 tigecycline-treated subjects and 142/1393 comparator-treated subjects presented with intestinal perforations. Of these subjects, 8/140 subjects treated with tigecycline and 8/142 subjects treated with comparator developed sepsis/septic shock. 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).
Pancreatitis acute, which can be fatal, has occurred (frequency: uncommon) in association with tigecycline treatment (see Adverse Reactions). The diagnosis of pancreatitis acute should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of pancreatitis acute. 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 patients suspected of having developed pancreatitis.
Monitoring of blood coagulation parameters, including blood fibrinogen, is recommended prior to treatment initiation with tigecycline and regularly while on treatment. (See Adverse Reactions).
The safety and efficacy of tigecycline in patients with hospital acquired pneumonia (HAP) have not been established. In a study of subjects with HAP, subjects were randomized to receive tigecycline (100 mg initially, then 50 mg every 12 hours) or a comparator. In addition, subjects were allowed to receive specified adjunctive therapies. The sub-group of subjects with ventilator-associated pneumonia (VAP) who received tigecycline had lower cure rates (47.9% versus 70.1% for the clinically evaluable population) and greater mortality (25/131 [19.1%] versus 15/122 [12.3%]) than the comparator. Of those subjects with VAP and bacteremia at baseline, those who received tigecycline had greater mortality (9/18 [50.0%] versus 1/13 [7.7%]) than the comparator.
As with other antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If super infection occurs, appropriate measures should be taken.
Abuse and Dependence: Drug abuse and dependence have not been demonstrated and are unlikely.
Effects on ability to drive and use machines: Tigecycline can cause dizziness (see Adverse Reactions), which may impair the ability to drive and/or operate machinery.