Author: Wyeth Europa Ltd


Long information

What is it?

Tygacil is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance tigecycline.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Tygacil is used to treat adults with complicated infections of the skin and soft tissue (the tissue below the skin), but not foot infections in people with diabetes). It is also used to treat complicated infections in the abdomen. ?Complicated? means that the infection is difficult to treat. Tygacil should be used only when other antibiotics are not suitable. Before using Tygacil, doctors should consider official guidance on the appropriate use of antibiotics.

The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Tygacil is a starting dose of 100 mg, followed by 50 mg every 12 hours for five to 14 days. Each infusion should last between 30 and 60 minutes. The length of treatment depends on where the infection is, how severe it is, and the patient?s response to treatment. Doses are lower in patients with severe liver problems.

How does it work?

The active substance in Tygacil, tigecycline, belongs to a group of antibiotics called ?glycylcyclines?. It works by blocking the bacteria?s ribosomes, the parts of the cell where new proteins are made. By blocking the production of new proteins, the bacteria cannot multiply and they eventually die. The list of bacteria against which Tygacil is active can be found in the summary of product characteristics (also part of the EPAR).

How has it been studied?

Tygacil has been compared with other antibiotics in four main studies. In two of these studies, Tygacil was compared with the combination of vancomycin and aztreonam in 1,129 patients with complicated skin and soft tissue infections (not including infected diabetic foot ulcers). In the other two studies, Tygacil was compared with imipenem/cilastatin (a combination of two medicines used together as an antibiotic) in 1,568 patients with complicated infections in the abdomen. An additional study compared Tygacil with the antibiotic ertapenem in 813 diabetic patients with moderate to severe foot infections.

In all of the studies, the main measure of effectiveness was the number of patients whose infection was cured.

What benefits has it shown during the studies?

In the four main studies, Tygacil was as effective as the comparator antibiotics. In the studies of skin and soft tissue infections, around 86% of the patients receiving Tygacil were cured, compared with around 89% of those receiving vancomycin and aztreonam. In the studies of abdominal infection, around 86% of the patients receiving either Tygacil or imipenem/cilastatin were cured.

In the study looking at diabetic foot infections, Tygacil was less effective than ertapenem: 78% of the patients receiving Tygacil were cured, compared with 83% of those receiving ertapenem.

What is the risk associated?

The most common side effects with Tygacil are mild to moderate nausea (feeling sick) and vomiting, seen in 20% and 14% of patients, respectively. For the full list of all side effects reported with Tygacil, see the package leaflet.

Tygacil should not be used in people who may be hypersensitive (allergic) to tigecycline or any of the other ingredients. Patients allergic to tetracycline antibiotics may also be allergic to Tygacil.

Why has it been approved?

The CHMP decided that Tygacil?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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