titution & dilution of the medicinal product before administration, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. Patients hypersensitive to tetracycline class antibiotics may be hypersensitive to tigecycline.
4.4 Special warnings and precautions for use
In clinical studies in complicated skin and soft tissue infections, complicated intra-abdominal infections, diabetic foot infections, nosocomial pneumonia and studies in resistant pathogens, a numerically higher mortality rate among Tygacil treated patients has been observed as compared to the comparator treatment. The causes of these findings remain unknown, but poorer efficacy and safety than the study comparators cannot be ruled out.
Patients who develop super-infections, in particular nosocomial pneumonia, appear to be associated with poorer outcomes. Patients should be closely monitored for the development of super-infection. If a focus of infection other than cSSTI or cIAI is identified after initiation of Tygacil therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Tygacil is not approved for clinical indications other than complicated skin and soft tissue infections, and complicated intra-abdominal infections. The use of Tygacil in non-approved indications is not recommended.
Anaphylaxis/anaphylactoid reactions, potentially life-threatening, have been reported with tigecycline (see sections 4.3 and 4.8).
Cases of liver injury with a predominantly cholestatic pattern have been reported in patients receiving tigecycline treatment, including some cases of hepatic failure with a fatal outcome. Although hepatic failure may occur in patients treated with tigecycline due to the underlying conditions or concomitant medicinal products, a possible contribution of tigecycline should be considered (see section 4.8).
Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics. Tigecycline may have adverse reactions similar to tetracycline class antibiotics. Such reactions may include photosensitivity, pseudotumor cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.8).
Acute pancreatitis, which can be serious, has occurred (frequency: uncommon) in association with tigecycline treatment (see section 4.8). The diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis. Most of the reported cases developed after at least one week of treatment. 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.
Experience in the use of tigecycline for treatment of infections in patients with severe underlying diseases is limited.
In clinical trials in complicated skin and soft tissue infections, the most common type of infection in tigecycline treated-patients was cellulitis (59 %), followed by major abscesses (27.5 %). Patients with severe underlying disease, such as those that |
