Relebactam

RECARBRIO is an antibacterial drug [see Microbiology (12.4) ].

• RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). ( 1.1 ) Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options.ICD-10: J18.9, N39.0

• RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity (severe systemic allergic reaction such as anaphylaxis) to any component of RECARBRIO. RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO.contraindicated

Adult Patients: The recommended dosage of RECARBRIO is 1.25 grams (imipenem 500 mg, cilastatin 500 mg, relebactam 250 mg) administered by intravenous (IV) infusion over 30 minutes every 6 hours to adult patients with creatinine clearance (CLcr) 90 mL/min or greater. ( 2.1 ) Pediatric Patients weighing at least 2 kg: The recommended dosage of RECARBRIO for pediatric patients weighing at least 2kg varies by patient weight and age, with specific dosing recommendations as shown in the table below, ( 2.2 ): Recommended Dosage of RECARBRIO In Pediatric Patients Weighing at Least 2 kg Age Range Body Weight Dose Dosing Frequency Infusion Duration Birth Pediatric patients from birth (includes pediatric patients at least 37 weeks post-menstrual age) to less than 3 months 2 kg or greater RECARBRIO 37.5 Provides 15 mg/kg imipenem, 15 mg/kg cilastatin, and 7.5 mg/kg relebactam mg/kg Every 8 hours 60 minutes 3 months to less than 18 years less than 30 kg RECARBRIO 37.5 mg/kg Every 6 hours 60 minutes 3 months to less than 18 years 30 kg or greater RECARBRIO 1.25 Provides 500 mg imipenem, 500 mg cilastatin, and 250 mg, relebactam grams Every 6 hours 30 minutes Dose reduction is required in adult and pediatric (weighing at least 30 kg) patients with renal impairment. ( 2.3 , 2.4 ) Do not administer RECARBRIO to adults with CLcr less than 15 mL/min unless hemodialysis is instituted within 48 hours after dose administration.

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta lactam drugs. Discontinue RECARBRIO immediately if a hypersensitivity reaction occurs. ( 5.1 ) Seizures and Central Nervous System Adverse Reactions: CNS adverse reactions such as seizures have been reported with imipenem/cilastatin, a component of RECARBRIO. If focal tremors, myoclonus, or seizures occur, evaluate patients, to determine whether RECARBRIO should be discontinued. ( 5.2 ) Increased Seizure Potential Due to Interaction with Valproic Acid: Concomitant use of RECARBRIO with valproic acid or divalproex sodium may reduce the serum concentration of valproic acid which may increase the risk of breakthrough seizures. Avoid concomitant use or consider alternative antibacterial drugs other than carbapenems. ( 5.3 , 7.2 ) Clostridioides difficile -Associated Diarrhea (CDAD): Has been reported with RECARBRIO. Evaluate if diarrhea occurs. ( 5.4 ) 5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta lactams. Before initiating therapy with RECARBRIO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If a hypersensitivity reaction to RECARBRIO occurs, discontinue the therapy immediately.

The following serious adverse reactions are described in greater detail in the Warnings and Precautions section. Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Seizures and Other Central Nervous System Adverse Reactions [see Warnings and Precautions (5.2) ] Increased Seizure Potential Due to Interaction with Valproic Acid [see Warnings and Precautions (5.3) ] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] Adult HABP/VABP Patients: The most frequently reported adverse reactions occurring in greater than or equal to 5% of patients treated with RECARBRIO were aspartate aminotransferase increased, anemia, alanine aminotransferase increased, diarrhea, hypokalemia, and hyponatremia. ( 6 ) Adult cUTI and cIAI Patients: The most frequently reported adverse reactions occurring in greater than or equal to 2% of patients treated with imipenem/cilastatin plus relebactam 250 mg, the components of RECARBRIO, were diarrhea, nausea, headache, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, phlebitis/infusion site reactions, pyrexia, and hypertension. ( 6 ) Pediatric HABP/VABP, cUTI, and cIAI Patients: The most frequently reported adverse reactions occurring in greater than 3% of pediatric patients treated with RECARBRIO were vomiting, diarrhea, nausea, headache, phlebitis/infusion site reactions, and rash. To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8.1 Pregnancy Risk Summary Embryonic loss was observed in monkeys treated with imipenem/cilastatin, and fetal abnormalities were observed in relebactam-treated mice; therefore, advise pregnant women of the potential risks to pregnancy and the fetus. There are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with RECARBRIO, imipenem, cilastatin, or relebactam in pregnant women. Developmental toxicity studies with imipenem and cilastatin (alone or in combination) administered parenterally during organogenesis to mice, rats, rabbits, and monkeys at doses 1 to 5 times the maximum recommended human dose (MRHD of imipenem 500 mg/cilastatin 500 mg every 6 hours for total daily doses of imipenem 2000 mg/cilastatin 2000 mg) based on body surface area comparison, showed no drug-induced fetal malformations. Embryofetal development studies with imipenem/cilastatin administered to cynomolgus monkeys at doses similar to the MRHD (based on body surface area comparison) showed an increase in embryonic loss.

Metabolism

The steady-state pharmacokinetic parameters of imipenem, cilastatin, and relebactam in healthy adults with normal renal function (CLcr 90 mL/min or greater), after multiple 30-minute intravenous infusions of RECARBRIO administered every 6 hours are summarized in Table 7 . Pharmacokinetic parameters were similar for single and multiple dose administration due to minimal accumulation.

In the event of overdose, discontinue RECARBRIO, treat symptomatically, and institute general supportive treatment. Imipenem, cilastatin, and relebactam can be removed by hemodialysis [see Clinical Pharmacology (12.3) ] . No clinical information is available on the use of hemodialysis to treat overdosage.

• Jul 16, 2019NDANDA212819Msd Merck Co

1. 1Off Label Use1820%
2. 2Death1416%
3. 3Product Use In Unapproved Indication910%
4. 4Pathogen Resistance89.0%
5. 5Drug Ineffective66.7%
6. 6Cardio-respiratory Arrest55.6%
7. 7Generalised Tonic-clonic Seizure55.6%
8. 8Overdose55.6%
9. 9Epilepsy44.5%
10. 10Therapy Non-responder44.5%
11. 11Condition Aggravated33.4%
12. 12Extradural Abscess33.4%
13. 13Incorrect Dose Administered33.4%
14. 14Incorrect Product Administration Duration33.4%
15. 15Klebsiella Bacteraemia33.4%

The 10 most recently updated of 19 ClinicalTrials.gov registrations naming Relebactam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
  Completed · Phase 2 · Interventional · 100 enrolled · M.D. Anderson Cancer Center
  NCT04983901updated 2026-04-06
• Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
  Completed · Phase 2 · Phase 3 · Interventional · 115 enrolled · Merck Sharp & Dohme LLC
  NCT03969901updated 2026-02-05
• Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2)
  Completed · Phase 3 · Interventional · 450 enrolled · Evopoint Biosciences Inc.
  NCT05204563updated 2025-11-06
• Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)
  Completed · Phase 3 · Interventional · 274 enrolled · Merck Sharp & Dohme LLC
  NCT03583333updated 2025-01-29
• Imipenem/Cilastatin/Relebactam Pharmacokinetics, Safety, and Outcomes in Adults and Adolescents With Cystic Fibrosis
  Terminated · Phase 4 · Interventional · 4 enrolled · Hartford Hospital
  NCT05561764updated 2024-12-17
• Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
  Withdrawn · Phase 4 · Interventional · 0 enrolled · University of Illinois at Chicago
  NCT05146154updated 2024-11-27
• Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections
  Withdrawn · Phase 4 · Interventional · 0 enrolled · Wake Forest University Health Sciences
  NCT04785924updated 2024-09-04
• Imipenem/Cilastatin/Relebactam PK in ECMO
  Completed · Phase 1 · Interventional · 8 enrolled · Joseph L. Kuti, PharmD
  NCT04493151updated 2024-08-07
• Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance
  Completed · Phase 1 · Interventional · 9 enrolled · Hartford Hospital
  NCT04147221updated 2024-08-06
• Use of New Antibiotics in Sweden
  Completed · Observational · 41 enrolled · Uppsala University
  NCT05048693updated 2024-06-18

Frequently asked questions

How does Relebactam work?

RECARBRIO is an antibacterial drug [see Microbiology (12.4) ].

What is Relebactam used for?

According to FDA labeling, Relebactam carries indications including: RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). ( 1.1 ) Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Relebactam?

Relebactam is classified as beta Lactamase Inhibitors.

What are the brand names for Relebactam?

Relebactam is marketed under brand names including Recarbrio.

What are the contraindications for Relebactam?

Relebactam labeling lists contraindications including: RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity (severe systemic allergic reaction such as anaphylaxis) to any component of RECARBRIO. RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO.. Always consult the full prescribing information and a clinician.