FDA Approves Antibiotic Recarbrio to Treat Hospital-Acquired Bacterial Pneumonia

Antibiotic Recarbrio to Treat Hospital-Acquired Bacterial Pneumonia
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FDA Approves Antibiotic Recarbrio to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

The U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older. Recarbrio was previously FDA-approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options.

HABP and VABP are a type of pneumonia that occurs in hospitalized patients and can cause symptoms such as fever, chills, cough, chest pain and increased oxygen requirements. Recarbrio is a combination of imipenem-cilastatin and relebactam. The drug is administered intravenously by a health care professional.

The safety and efficacy of Recarbrio for the treatment of HABP/VABP were evaluated in a randomized, controlled clinical trial of 535 hospitalized adults with HABP/VABP due gram-negative bacteria (a type of bacteria) in which 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin-tazobactam, another antibacterial drug. Overall, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam died through Day 28 of the study.

The most common adverse reactions observed in patients treated with Recarbrio for HABP/VABP included:

  • Increased aspartate/alanine aminotransferases (increased liver enzymes)
  • Anemia
  • Diarrhea
  • Hypokalemia (low potassium)
  • Hyponatremia (low sodium)

Before initiating therapy with Recarbrio, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams and other allergens. Recarbrio should not be used in patients who are prone to seizures and other central nervous system disorders. Clostridioides difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including Recarbrio, and may range in severity from mild diarrhea to fatal colitis.

Reference: FDA

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