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Recarbrio Approval History

Reviewed by J.Stewart BPharm Last updated on Jul 21, 2019.

FDA Approved: Yes (First approved July 16, 2019)
Brand name: Recarbrio
Generic name: imipenem, cilastatin, and relebactam
Dosage form: for Injection
Company: Merck
Treatment for: Urinary Tract Infection, Intraabdominal Infection

Recarbrio (imipenem, cilastatin, and relebactam) is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a betalactamase inhibitor, indicated for the treatment of complicated urinary tract infections and complicated intra-abdominal infections (cIAI).

  • The imipenem and cilastatin combination has been available for decades, and the addition of relebactam to the mix protects imipenem from degradation by certain serine beta lactamases, potentially overcoming antimicrobial resistance and extending the spectrum of activity of the antibiotic.
  • Recarbrio is administered via intravenous (IV) infusion over 30 minutes every 6 hours.
  • Patients receiving Recarbrio should be made aware of the potential for hypersensitivity reactions, seizures and central nervous system reactions, an increased risk of seizures due to the drug interaction between Recarbrio and valproic acid or divalproex sodium, and the possibility of watery or bloody diarrhea as a result of Clostridium difficile infection.
  • Common side effects include diarrhea, nausea, headache, vomiting, increased liver enzymes, infusion site reactions, fever, and hypertension.

Development History and FDA Approval Process for Recarbrio

DateArticle
Jul 17, 2019Approval FDA Approves Recarbrio (imipenem, cilastatin, and relebactam) for the Treatment of Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections
Feb  5, 2019FDA Accepts for Review New Drug Application (NDA) for Merck’s Investigational Combination of Imipenem/Cilastatin and Relebactam
Apr 22, 2018Pivotal Phase 3 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Demonstrated Favorable Overall Response Against Certain Imipenem–Non-Susceptible Bacterial Infections
Jun 20, 2016Results of Phase 2 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Presented at ASM Microbe
Sep 18, 2015Results of Phase 2 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam Presented at ICAAC/ICC 2015
Sep  4, 2014Merck’s Beta-lactamase Inhibitor Relebactam Granted QIDP and Fast Track Designations by FDA

Further information

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