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Imipenem-cilastatin-relebactam

[Imipenem-cilastatin-relebactam photo: pending]

KEY POINTS

  • Imipenem-cilastatin-relebactam (Recarbrio) is the combination of three molecules…
    • Imipenem is a carbapenem and beta-lactam antibiotic that inhibits bacterial cell wall synthesis through binding to penicillin binding proteins
    • Cilastatin is a dehydropeptidase-I (DHP-I) inhibitor that prevents inactivation of imipenem by renal DHP-I
      • Has no antibacterial activity
    • Relebactam is a class A/C beta-lactamase inhibitor
      • Previously named MK-7655 during drug development
  • FDA-approved July 17th, 2019 in patients 18 years and older with limited or no treatment options for…
    • Complicated urinary tract infection
    • Complicated intra-abdominal infections
  • Imipenem-cilaststin (Primaxin) has been available for decades, but imipenem-cilastatin-relebactam is a new product
    • Is the first FDA-approved product to include relebactam
      • Relebactam can restore the activity of imipenem-cilastatin in resistant organisms, including some carbapenem-resistant Klebsiella and Pseudmonas
  • Imipenem-cilastatin-relebactam should be reserved for patients who have infection with drug-resistant bacteria
  • Dose as 1.25 grams (imipenem 500 mg, cilastatin 500 mg, relebactam 250 mg) IV every 6 hours, administered over 30 minutes
    • Adjust doses downwards in patients with CrCl below 90 mL/min
    • Not recommended in CrCl below 15 mL/min if dialysis not started within 48 hours
    • Product maintains potency for 2 hours at room temperature and 24 hours under refrigeration
  • Beware potential seizures and central nervous reactions
    • Consider avoiding use for patients on ganciclovir since generalized seizures have been reported
    • Avoid use in patients on valproic acid (VPA) or divalproex sodium since a reduction in VPA levels may lead to seizures
  • The most common side effects in clinical trials were: diarrhea, nausea, headache, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, phlebitis/infusion site reactions, pyrexia, and hypertension
  • RECARBRIO –> RE (relebactam) – CARB (carbapenem) – RIO (trio of molecules)
    • Thanks @ABsteward!

RESOURCES

  • Recarbrio package insert
  • FDA news release for imipenem-cilastatin-relebactam approval
  • Defining the Role of Novel β-Lactam Agents That Target Carbapenem-Resistant Gram-Negative Organisms
  • RESTORE-IMI trial description
  • In Vitro Activity of MK-7655, a Novel β-Lactamase Inhibitor, in Combination with Imipenem against Carbapenem-Resistant Gram-Negative Bacteria
  • Phase 2, Dose-Ranging Study of Relebactam with Imipenem-Cilastatin in Subjects with Complicated Intra-abdominal Infection
  • In Vitro Activity of Imipenem–Relebactam against Gram-Negative ESKAPE Pathogens Isolated by Clinical Laboratories in the United States in 2015 (Results from the SMART Global Surveillance Program)
  • Prospective, randomized, double-blind, Phase 2 dose-ranging study comparing efficacy and safety of imipenem/cilastatin plus relebactam with imipenem/cilastatin alone in patients with complicated urinary tract infection
  • Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Relebactam, a β-Lactamase Inhibitor, in Combination with Imipenem and Cilastatin in Healthy Participants


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