Tygacil - tigecycline

Characteristics of the medicinal product

Tygacil is an orange colored powder for solution for infusion (drip into a vein). Tygacil contains the active ingredient tigecycline.

Therapeutic indications

Tygacil is an antibiotic. It is used in adults who have complicated infections of the abdomen or complicated infections of the skin and soft tissues (infections of the skin and tissues under the skin). Before using Tygacil, doctors should consult the official guidelines available to them on the correct use of antibiotics.

The medicine can only be obtained with a prescription.

Method of use

The recommended dose is an initial dose of 100 mg, followed by 50 mg every 12 hours for a period of 5 to 14 days. Each infusion should last from 30 to 60 minutes. The duration of treatment depends on the site where the infection is located, its severity and the patient's response to treatment. In patients with severe liver problems the doses should be reduced.

Mechanisms of action

Tygacil contains the active ingredient tigecycline, which belongs to a group of antibiotics similar to tetracyclines, glycylcycline. Tygacil works by blocking the ribosomes of bacteria, ie the parts of the cell where new proteins are produced. If the bacteria are no longer able to produce proteins, they cannot multiply and eventually die. The bacteria against which Tygacil is active are listed in the Summary of Product Characteristics.

Studies carried out

The efficacy of Tygacil has been analyzed in four main studies. Two of these were conducted on 1, 568 patients with complicated intra-abdominal infections (in half the cases it was complicated appendicitis) and compared Tygacil with imipenem / cilastatin. The other two studies, which were conducted on 1, 129 patients with complicated skin and soft tissue infections (in half of the cases it was cellulitis that required hospitalization), compared Tygacil with a combination of vancomycin and aztreonam. All studies measured the clinical response (healing from infection or failure of care).

Benefits found following the studies

In all of the studies, Tygacil was as effective as the comparative antibiotics, and the percentages of patients whose infection was resolved were similar: 80.6 and 91.3% in studies of abdominal infections versus 82.4 and 89.9% for the comparator drug, and 82.9% and 89.7% for skin and soft tissue infections, against 82.3 and 94.4% for the comparative drug combination.

Associated risks

The most common side effects (seen in more than 1 patient in 10) are nausea, vomiting and diarrhea. For the complete list of side effects reported with the use of 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 tetracyclines may also be allergic to Tygacil.

Grounds for approval

The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Tygacil outweigh its risks in the treatment of complicated skin and soft tissue infections and in the treatment of complicated intra-abdominal infections. Therefore, the committee recommended that the marketing authorization be granted to Tygacil.

Measures taken to ensure the safe use of Tygacil

The company that makes Tygacil will closely monitor the development of any resistance (a situation in which a germ initially sensitive to the action of an antibiotic then becomes able to counteract its effects), will carefully examine the interaction mechanism of Tygacil and warfarin ( a drug used to thin the blood) and the use of Tygacil in patients with problems of elimination of bile (cholestasis).