Relebactam combo receives FDA approval for treating nosocomial pneumonia

Relebactam combo receives FDA approval for treating nosocomial pneumonia

The US FDA has recently approved an intravenous (IV) combinatorial drug of antibiotics imipenem/cilastatin and relebactam (Recarbrio, Merck) to treat nosocomial bacterial pneumonia in patients of 18 years and older.

The safety and efficacy of the drug combination was evaluated in a randomised cohort of 535 hospitalized adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused due to gram-negative bacteria. Out of these, 266 patients received Recarbrio and 269 patients were treated with antibiotic piperacillin-tazobactam.

Overall mortality in the Recarbrio cohort was 16% compared to 21% in the group that received piperacillin-tazobactam through day 28 of the study.

The most common adverse reactions observed involved increased liver enzymes, anaemia, diarrhoea, hypokalemia (low potassium) and hyponatremia (low sodium).

The physicians are recommended to inquire about any prior hypersensitivity towards carbapenems, penicillins, cephalosporins, other beta-lactams and other allergens before prescribing the combo. The drug should not be used in patients who are prone to seizures and other central nervous system disorders.