European Medicines Agency advises doctors treating patients with nosocomial pneumonia with Doribax
Current dosing recommendations may not be enough for serious cases; no change in advice for all other approved indications
London, UK (June 22, 2012) - The European Medicines Agency has given new advice for the treatment of patients with nosocomial pneumonia, also known as hospital-acquired pneumonia, with Doribax (doripenem). A review of available data raises concerns that the currently approved dose of Doribax of 500mg every 8 hours may not be sufficient to treat all patients with nosocomial pneumonia, including ventilator-associated pneumonia.
Nosocomial pneumonia is caused by bacterial infection, and Doribax is one of a limited number of medicines available to treat this life-threatening disease.
Doctors should exercise particular caution in patients for whom non-fermenting gram-negative pathogens such as Pseudomonas aeruginosa and Acinetobacter are suspected or confirmed as the cause of infection. In some of these patients, doctors should consider initiating concomitant treatment with an aminoglycoside antibiotic.
The review of Doribax was initiated following the early termination of a study by the marketing authorisation holder in patients with ventilator-associated pneumonia. The study tested a fixed 7-day treatment course with 1g Doribax against a fixed 10-day course with 1g of a comparator drug (imipenem/cilastatin). The study was stopped following a recommendation from an independent data monitoring committee because the patients treated with Doribax were less likely to recover than the patients in the comparator group.
The Committee therefore concluded that the benefits of Doribax continue to outweigh its risks but recommended updating the prescribing information to allow using a higher dose in certain patients with hospital-acquired pneumonia and to clarify the recommendations and warnings on the use of Doribax in different types of bacterial infection.
European Medicines Agency (EMA), 22.06.2012 (tB).