Imipenem, cilastatin, and relebactam

(Recarbrio®)

Recarbrio®

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 1.25 g/vial)
Drug ClassPenem antibacterial, renal dehydropeptidase inhibitor, betalactamase inhibitor
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
  • Indicated in patients 18 years of age and older for the treatment of complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options.
  • Indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options.

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Summary
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  • Recarbrio (imipenem, cilastatin, and relebactam) is indicated in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP); indicated in patients 18 years of age and older for the treatment of complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options; and indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options.
  • This summary is based on the review of 23 systematic reviews/meta-analyses. [1-2]
  • Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP): Recarbrio (imipenem, cilastatin, and relebactam) demonstrated comparable efficacy in treating Pseudomonas aeruginosa infections to other novel β-lactams such as ceftolozane-tazobactam, ceftazidime-avibactam, and cefiderocol, with no significant differences in performance across various infection sites and drug resistance profiles.
  • Complicated Urinary Tract Infections (cUTIs): Recarbrio achieved higher clinical cure rates and microbiological eradication rates at test of cure compared to control groups. Network meta-analysis indicated that meropenem/vaborbactam, ertapenem, and biapenem had superior clinical and microbiological treatment success rates compared to other carbapenems like imipenem/cilastatin.
  • Complicated Intra-Abdominal Infections (cIAIs): Recarbrio showed no statistically significant differences in efficacy when compared to antibiotics such as tigecycline, meropenem, and ertapenem. Eravacycline outperformed tigecycline and demonstrated comparable efficacy to other conventional treatments.
  • Burn Patients: In burn patients, achieving adequate pharmacokinetic/pharmacodynamic (PK/PD) targets required high doses and continuous infusion of broad-spectrum beta-lactams, including imipenem.
  • Adverse Events (AEs): Recarbrio exhibited a similar risk of treatment-emergent adverse events (TEAEs) compared to control groups in studies on complicated urinary tract infections, with no significant differences in the incidence of serious adverse events, discontinuation rates, or all-cause mortality when compared to other antibiotics, including eravacycline.
  • Specific Safety Concerns: Imipenem was associated with higher rates of clinical or microbiological failure in complicated intra-abdominal infections compared to alternative β-lactam monotherapy or combination therapy.
  • Complicated Intra-Abdominal Infections: Eravacycline displayed a comparable safety profile to other antibiotics, though tigecycline showed a higher risk of adverse events compared to imipenem/cilastatin.
  • Subgroup Findings: In burn patients, high doses and continuous infusion of broad-spectrum beta-lactams, including imipenem, are necessary to achieve therapeutic targets due to altered pharmacokinetic/pharmacodynamic (PK/PD) properties, while imipenem shows relatively low resistance rates in children with ESBL-producing Enterobacteriaceae.