Exblifep

The medicine can only be obtained with a prescription.

Exblifep is given as an infusion (drip) into a vein. The infusion is given every 8 hours and lasts 2 hours (for complicated urinary tract infection, including pyelonephritis) or 4 hours (for hospital-acquired pneumonia, including ventilator-associated pneumonia).

The duration of treatment is 7 to 14 days depending on the severity and location of the infection and the response to treatment.

For more information about using Exblifep, see the package leaflet or contact your doctor or pharmacist.

The active substances in Exblifep, cefepime and enmetazobactam, work in different ways.

Cefepime is a type of antibiotic called a cephalosporin, which belongs to the wider group of antibiotics called “beta-lactams”. It works by preventing certain bacteria from making their own cell walls, thereby killing the bacteria.

Enmetazobactam blocks the action of some of the bacterial enzymes called beta-lactamases. These enzymes enable bacteria to break down beta-lactam antibiotics like cefepime, making the bacteria resistant to the antibiotic’s action. By blocking the action of these enzymes, enmetazobactam allows cefepime to act against bacteria that would otherwise be resistant to this antibiotic.

In a study involving 1041 adults, Exblifep was shown to be more effective than another antibiotic combining a beta-lactam and a beta-lactamase inhibitor (piperacillin and tazobactam) at treating complicated urinary tract infections, including acute pyelonephritis (sudden kidney infection). After 7 to 14 days, around 79% (273 out of 345) of patients treated with Exblifep had a favourable outcome (as measured by being cured of their symptoms and the absence of the bacteria that caused the infection in the blood) compared to around 59% (196 out of 333) of patients treated with piperacillin and tazobactam.

A study involving 19 healthy adults evaluated the distribution of Exblifep in the body. It showed that the medicine is able to penetrate the lungs sufficiently to support the use of Exblifep in the treatment of hospital-acquired pneumonia.

For the full list of side effects and restrictions with Exblifep, see the package leaflet.

The most common side effects with Exblifep (which may affect up to 1 in 10 people) include high levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes), as well as diarrhoea and phlebitis (inflammation of a vein) at the site of infusion. Serious side effects with Exblifep include colitis (inflammation of the colon) due to the bacteria Clostridioides difficile (which may affect more than 1 in 1,000 people).

Exblifep must not be used in people who are hypersensitive (allergic) to the cephalosprin group of antibiotics or who have severe hypersensitivity to other beta-lactam antibiotics.

The European Medicines Agency decided that Exblifep’s benefits are greater than its risks and it can be authorised for use in the EU.

At the time of approval of Exblifep, there was an unmet medical need for antibiotics that are safe and effective in treating infections caused by bacteria resistant to multiple authorised antibiotics. Studies show that Exblifep is effective in treating complicated urinary tract infections, including pyelonephritis, and hospital-acquired pneumonia, including ventilator-associated pneumonia, with or without bacteraemia. Therefore, Exblifep is an alternative treatment for these difficult-to-treat infections, especially those caused by bacteria producing certain types of beta-lactamases. The side effects of Exblifep are generally similar to those of other antibiotics of the same family and of cefepime when used alone. Overall, the safety profile of Exblifep was considered acceptable.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Exblifep have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Exblifep are continuously monitored. Suspected side effects reported with Exblifep are carefully evaluated and any necessary action taken to protect patients.

Exblifep received a marketing authorisation valid throughout the EU on 21 March 2024.