What is Dificlir - Fidaxomicina?
Dificilir is a medicine that contains the active substance fidaxomicin. The medicine is available as tablets (200 mg).
What is Dificlir - Fidaxomicina used for?
Dificlir is used to treat adults with intestinal infections caused by the bacterium called Clostridium difficile. The medicine can only be obtained with a prescription.
How is Dificlir - Fidaxomicina used?
The recommended dose is one tablet twice a day (every 12 hours) for 10 days.
How does Dificlir - Fidaxomicina work?
C. Difficult bacteria are naturally present in the intestine and do not cause any problems to healthy people. However, some antibiotics used to treat infections can interfere with the balance of "good" bacteria in the intestine. When this happens, C. difficile bacteria can multiply and produce toxins (poisons) that cause illness, such as diarrhea and fever. At this point, it is said that a person is infected with C. difficile.
The active substance in Dificlir, fidaxomicin, is an antibiotic that belongs to the new class of macrocyclic antibiotics. When swallowed, most of the active ingredient is not absorbed into the bloodstream, but acts locally in the C. difficile bacteria in the intestine. It works by blocking the bacterial enzyme RNA polymerase, which is used to produce the RNA that bacteria need to produce proteins. In this way the growth and multiplication of the C. difficile bacterium is stopped.
What studies have been performed on Dificlir - Fidaxomicina?
Before being studied in humans, the effects of Dificlir were analyzed in experimental models.
Dificlir was compared with vancomycin (another antibiotic for C. difficile infections) in two main studies involving a total of 1 147 patients with C. difficile infection in mild to moderately severe form. The main measure of effectiveness was the number of patients recovered 10 days after treatment.
What benefit has Dificlir - Fidaxomicina shown during the studies?
Dificlir was as effective as vancomycin in treating C. difficile infection. When examining the results of the two studies, 92% of patients treated with Dificlir recovered, compared with 90% of patients treated with vancomycin.
What is the risk associated with Dificlir - Fidaxomicina?
The most common side effects seen with Dificlir (seen in between 1 and 10 patients in 100) are nausea, vomiting and constipation. For the full list of all side effects reported with Dificlir, see the package leaflet.
Dificlir should not be used in people who may be hypersensitive (allergic) to fidaxomicin or any of the other ingredients.
Why has Dificlir - Fidaxomicina been approved?
The CHMP considered that Dificlir was effective in treating C. difficile infections and was generally well tolerated with side effects similar to vancomycin. However, the CHMP noted that there are uncertainties about the effects of Dificlir in certain groups of patients such as those with liver and kidney problems and recommended further studies in this group. The CHMP considered the severity of C. difficile infections and the drawbacks of current treatments and decided that Dificlir's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Dificlir - Fidaxomicina
On 5 December 2011, the European Commission issued a marketing authorization for Dificlir, valid throughout the European Union.
For more information about treatment with Dificlir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
