What is Doribax?
Doribax is a medicine containing the active substance doripenem. The medicine is available as a powder for solution for intravenous infusion (drip into a vein).
What is Doribax used for?
Doribax is an antibiotic. It is used to treat the following infections in adults:
- Nosocomial pneumonia (an infection of the lungs). "Nosocomial" means that the infection has been contracted in the hospital and includes pneumonia caused by the use of a ventilation device (a machine that helps a patient breathe);
- complicated infections of the abdomen. "Complicated" means that the infection is difficult to treat;
- complicated urinary tract infections (the structures that carry urine).
Before using Doribax, doctors must take into account official guidelines on the use of antibiotics.
The medicine can only be obtained with a prescription.
How is Doribax used?
The standard dose of Doribax is 500 mg every eight hours. Each infusion lasts an hour, although for some patients with pneumonia four-hour infusions may be necessary. Treatment generally continues for a number between 5 and 14 days, depending on the type and severity of the infection and the patient's response. Because the medicine is eliminated from the body through the kidneys, the dose of Doribax should be reduced in patients who have moderate or severe kidney problems.
Doribax is not recommended in children under the age of 18 due to a lack of data on the safety and efficacy of the medicine in this age group.
How does Doribax work?
The active ingredient in Doribax, doripenem, is an antibiotic belonging to the 'carbapenem' group. The substance works by binding to certain types of proteins on the surface of bacteria cells. This prevents the bacteria from building the walls that surround their cells, thus causing the death of the bacteria . The list of bacteria against which Doribax is active can be consulted in the summary of product characteristics (also included with the EPAR).
What studies have been carried out on Doribax?
The effects of Doribax were first tested in experimental models before being studied in humans.
Doribax has been tested in five main studies that compared Doribax with other antibiotics:
- two studies compared Doribax with piperacillin / tazobactam or imipenem in a total of 979 patients with nosocomial pneumonia;
- two studies compared Doribax with meropenem in a total of 962 patients with complicated abdominal infections;
- one study compared Doribax with levofloxacin in 753 patients with complicated urinary tract infections.
In all studies, the main indicator of effectiveness was the number of patients whose infection was treated following treatment.
What benefit has Doribax shown during the studies?
Doribax has been shown to be as effective as other antibiotics in treating infections:
- looking at the results of the two studies on nosocomial pneumonia overall, 75% of the patients receiving Doribax were treated (195 out of 260), compared to 72% of the patients taking piperacillin / tazobactam or imipenem (174 of 241);
- looking at the results of the two studies on complicated abdominal infections overall, 85% of the patients receiving Doribax were treated (275 of 325), compared to 84% of the patients receiving meropenem (260 out of 309);
- in complicated urinary tract infections, 82% of patients receiving Doribax were treated (230 out of 280) compared to 83% of patients receiving levofloxacin (221 out of 265).
What is the risk associated with Doribax?
The most common side effect of Doribax (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with Doribax, see the Package Leaflet.
Doribax should not be used in people who may be hypersensitive (allergic) to doripenem or to other carbapenems. The medicine should not be used in patients with severe allergies to other 'beta-lactam' antibiotics, such as eg. penicillins or cephalosporins.
Why has Doribax been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Doribax outweigh its risks for the treatment of nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections in adults. The committee recommended the granting of a marketing authorization for Doribax.
More information on Doribax:
On 25 July 2008, the European Commission granted a marketing authorization valid for Doribax throughout the European Union to Janssen-Cilag International NV.
For the full EPAR of Doribax, click here.
Last update of this summary: 06-2008
