Drug updated on 4/18/2024
| Dosage Form | Injection (intravenous; 1.25 g/vial) |
| Drug Class | Penem 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.
Summary
- Imipenem, cilastatin, and relebactam (Recarbrio) are indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), complicated urinary tract infections including pyelonephritis (cUTI), and complicated intra-abdominal infections (cIAI) in adults who have limited or no alternative treatment options.
- Twenty-two systematic reviews/meta-analyses were analyzed to gather information about Recarbrio’s safety and effectiveness compared to other antimicrobial therapies.
- Recarbrio has demonstrated effectiveness against gram-negative bacilli resistant to carbapenems, with a pooled resistance prevalence estimation of 14.6%, suggesting its utility where resistance is a concern.
- The safety profile of Recarbrio was found to be comparable to other antibiotics used in treating cUTIs; it showed similar rates of adverse events but had a higher clinical cure rate and microbiological eradication rate at the test-of-cure stage than traditional antibiotics.
- Among novel β-lactams evaluated for Pseudomonas aeruginosa infections, such as ceftolozane-tazobactam, ceftazidime-avibactam, and cefiderocol, Recarbrio demonstrated comparable efficacy indicating no inferiority towards these agents.
- Recarbrio could be effective in treating infections caused by multidrug-resistant organisms, especially among newborns; however, further research is needed to confirm this finding.
- The pharmacokinetic variability related specifically to ethnicity or pathological conditions did not indicate any need for dosage adjustment based on these characteristics alone, suggesting broad applicability across different demographic groups.
- In comparison with other combination therapies like ceftazidime/avibactam and ceftolozane/tazobactam, Recarbrio was not considered inferior. These combinations were associated with significant clinical success when dealing with carbapenem-resistant Enterobacterales (CRE) and/or multidrug-resistant Pseudomonas aeruginosa.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Recarbrio (imipenem, cilastatin, and relebactam) Prescribing Information. | 2022 | Merck & Co. Inc., Rahway, NJ |