FDA Approves Recarbrio for UTI and Intra-Abdominal Infections
Combination drug indicated for infections caused by susceptible gram-negative bacteria.
The FDA has announced the approval of Merck’s combination drug Recarbrio (imipenem, cilastatin and relebactam), indicated for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) in patients 18 years or older who have limited or no alternative treatment options.
Per prescribing information, Recarbrio should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
“The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections,” said Ed Cox, MD, director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research, in an statement. “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.”
The recent approval is based upon two studies examining the efficacy and safety of imipenem-cilastatin for the treatment of cUTI and cIAI. In the cUTI study, 298 adult patients received treatment, with 99 patients receiving the proposed dose of Recarbrio. In the cIAI study, 347 patints were included, with 117 receiving proposed doses of Recarbrio.
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Recarbrio is suggested to be administered at 1.25 grams (imipenem 500 mg, cilastatin 500 mg, relebactam 250 mg) by intravenous infusion over 30 minutes every six hours in patients 18 years of age and older with creatine clearance (CLcr) of 90 mL/min or greater. Patients with CRcl under 15 mL/min should not receive Recarbrio unless hemodialysis is instituted within 48 hours.
The most common adverse events reported throughout the clinical trails included nausea, diarrhea, headache, fever and increased liver enzymes.
Recarbrio is contraindicated in patients with a known severe hypersensitivity to any component of the combination drug.
Known adverse drug interactions listed in the prescribing information for Recarbrio include Gancivlovir and Valproic Acid or Divalproex Sodium.
Prescribign information for Recarbrio comes with warnings of hypersensitivity reactions, seizure and central nervous system adverse reactions, increased seizure potential due to interaction with valproic acid, and C. difficile-associated diarrhea.
