Tigecycline Accord

Posology Adults The recommended dose is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days. 2 mg/kg of tigecycline every 12 hours intravenously to a maximum dose of 50 mg every 12 hours for 5 to 14 days. Adolescents aged 12 to <18 years: 50 mg of tigecycline every 12 hours for 5 to 14 days.

The duration of therapy should be guided by the severity, site of the infection, and the patient’s clinical response. 2). 3 Hepatic impairment No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).

In patients (including paediatrics) with severe hepatic impairment (Child Pugh C), the dose of tigecycline should be reduced by 50 %. Adult dose should be reduced to 25 mg every 12 hours following the 100 mg loading dose. 2). 2). Paediatric population The safety and efficacy of Tigecycline Accord in children under 8 years of age have not been established.

No data are available. 1). 6). 4). 6.

Summary of safety profile The total number of cSSTI and cIAI patients treated with tigecycline in Phase 3 and 4 clinical studies was 2,393. In clinical trials, the most common medicinal product-related treatment emergent adverse reactions were reversible nausea (21 %) and vomiting (13 %), which usually occurred early (on treatment days 1-2) and were generally mild or moderate in severity.

Adverse reactions reported with tigecycline, including clinical trials and post-marketing experience, are tabulated below. 4). 4). Tetracycline class effects Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics.

4). 4). 3 %). 1 %) were observed. AST and ALT abnormalities in tigecycline-treated patients were reported more frequently in the post therapy period than in those in comparator-treated patients, which occurred more often on therapy. 7 % (37/2206) of patients receiving active comparators.

2). No new or unexpected safety concerns were observed with tigecycline in these studies. In an open-label, single ascending dose PK study, the safety of tigecycline was investigated in 25 children aged 8 to 16 years who recently recovered from infections.

The adverse reaction profile of tigecycline in these 25 subjects was generally consistent with that in adults. The safety of tigecycline was also investigated in an open-label, ascending multi-dose PK study in 58 children aged 8 to 11 years with cSSTI (n=15), cIAI (n=24) or community-acquired pneumonia (n=19).

9 %) which were seen at greater frequencies in children than in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

In clinical studies in complicated skin and soft tissue infections (cSSTI), complicated intra-abdominal infections (cIAI), diabetic foot infections, nosocomial pneumonia and studies in resistant pathogens, a numerically higher mortality rate among tigecycline 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. Superinfection In clinical trials in cIAI patients, impaired healing of the surgical wound has been associated with superinfection.

8). Patients who develop superinfections, in particular nosocomial pneumonia, appear to be associated with poorer outcomes. Patients should be closely monitored for the development of superinfection. If a focus of infection other than cSSTI or cIAI is identified after initiation of tigecycline 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.

8). 4 Hepatic failure 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. 8). Tetracycline class antibiotics Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics.

Tigecycline may have adverse reactions similar to tetracycline class antibiotics. 8). 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.

1. Patients hypersensitive to tetracycline class antibiotics may be hypersensitive to tigecycline.