Imipenem/cilastatin/relebactam

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Imipenem/cilastatin/relebactam
Combination of
Imipenemβ-Lactam antibiotic
CilastatinDehydropeptidase inhibitor
Relebactamβ-Lactamase inhibitor
Names
Trade namesRecarbrio
Other namesMK-7655A
Clinical data
Main usesHospital acquired pneumonia, sepsis, urinary tract infections, intra-abdominal infections[1][2]
Side effectsNausea, diarrhea, headache, fever, inflammation at the site of injection, increased liver enzymes[3]
Routes of
use
Intravenous
Typical dose1 to 1.25 gm QID[3]
External links
AHFS/Drugs.comMonograph
US NLMImipenem/cilastatin/relebactam
MedlinePlusa619046
Legal
License data
Legal status
  • US: ℞-only
  • EU: Rx-only [1]
  • In general: ℞ (Prescription only)

Imipenem/cilastatin/relebactam, sold under the brand name Recarbrio, is a combination medication and antibiotic used to treat hospital acquired pneumonia, sepsis, urinary tract infections, and intra-abdominal infections.[1][2] It is given by injection into a vein.[3]

Common side effects include include nausea, diarrhea, headache, fever, inflammation at the site of injection, and increased liver enzymes.[3] Other side effects may include Clostridioides difficile infection, seizures, and anaphylaxis.[3] Imipenem is a penem, cilastatin prevents its breakdown, and relebactam blocks the activity of beta-lactamase.[1]

The combination was approved for medical use in the United States in 2019 and Europe in 2020.[3][1] In the United Kingdom 25 doses cost the NHS about £3,800 as of 2021.[4] In the United States this amount costs about 7,200 USD.[5]

Medical uses

In the United States imipenem/cilastatin/relebactam is indicated for the treatment of people with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options.[6] It is also indicated to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults 18 years of age and older.[6]

In the European Union it is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.[1]

Dosage

In those with kidney function of a GFR of > 90 mL/min a dose of 1.25 mg 4 times per day is used while in those with a GFR of 60 to 90 mL/min a dose of 1 gram 4 times per day is used.[3]

History

The application for imipenem/cilastatin/relebactam was granted Qualified Infectious Disease Product (QIDP), fast track, and priority review designations by the U.S. Food and Drug Administration (FDA).[7] The FDA granted the approval of Recarbrio to Merck & Co., Inc.[7][6]

The determination of efficacy of imipenem/cilastatin/relebactam was supported in part by the findings of the efficacy and safety of imipenem-cilastatin for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).[7] The contribution of relebactam to imipenem/cilastatin/relebactam was assessed based on data from in vitro studies and animal models of infection.[7] The safety of imipenem/cilastatin/relebactam, administered via injection, was studied in two trials (Trial 1/NCT01505634, Trial 2/NCT01506271), one each for cUTI and cIAI.[7] The cUTI trial included 298 adult participants with 99 treated with the proposed dose of imipenem/cilastatin/relebactam.[7] The cIAI trial included 347 participants with 117 treated with the proposed dose of imipenem/cilastatin/relebactam.[7]

Trial 1 enrolled adult participants hospitalized with cUTI.[8] Trial 2 enrolled adult participants hospitalized with cIAI that required surgery or drainage.[8] In both trials, participants were assigned to either imipenem/cilastatin with varying doses of relebactam or imipenem/cilastatin with placebo intravenously, every 6 hours for 4 to 14 days.[8] Neither the participants nor the investigators knew which treatment was being given until after the trial was completed.[8] The trials were conducted in Europe, South America, the United States, Asia Pacific, Africa, and Mexico.[8]

It was approved for use in the European Union in February 2020.[1]

In June 2020, imipenem/cilastatin/relebactam was approved for the indication to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults 18 years of age and older.[6]

The safety and efficacy of imipenem/cilastatin/relebactam for the treatment of HABP/VABP were evaluated in a randomized, controlled clinical trial of 535 hospitalized adults with HABP/VABP due to Gram-negative bacteria (a type of bacteria) in which 266 participants were treated with imipenem/cilastatin/relebactam and 269 participants were treated with piperacillin-tazobactam, another antibacterial drug.[6] Overall, 16% of participants who received imipenem/cilastatin/relebactam and 21% of participants who received piperacillin-tazobactam died through day 28 of the study.[6]

See also

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Recarbrio EPAR". European Medicines Agency (EMA). 10 December 2019. Retrieved 1 March 2020.
  2. 2.0 2.1 "Recarbrio- imipenem anhydrous, cilastatin, and relebactam anhydrous injection, powder, for solution". DailyMed. 4 December 2019. Retrieved 1 March 2020.
  3. 3.0 3.1 3.2 3.3 3.4 3.5 3.6 "Imipenem, Cilastatin, and Relebactam Monograph for Professionals". Drugs.com. Retrieved 25 November 2021.
  4. BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 550. ISBN 978-0857114105.
  5. "Recarbrio Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 25 November 2021.
  6. 6.0 6.1 6.2 6.3 6.4 6.5 "FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia". U.S. Food and Drug Administration. 4 June 2020. Retrieved 4 June 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  7. 7.0 7.1 7.2 7.3 7.4 7.5 7.6 "FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections". U.S. Food and Drug Administration (FDA) (Press release). 17 July 2019. Archived from the original on 20 November 2019. Retrieved 20 November 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  8. 8.0 8.1 8.2 8.3 8.4 "Drug Trial Snapshot: Recarbrio". U.S. Food and Drug Administration (FDA). 2 August 2019. Archived from the original on 20 November 2019. Retrieved 20 November 2019. Public Domain This article incorporates text from this source, which is in the public domain.

External links

Identifiers:
  • "Imipenem". Drug Information Portal. U.S. National Library of Medicine.
  • "Cilastatin". Drug Information Portal. U.S. National Library of Medicine.
  • "Relebactam". Drug Information Portal. U.S. National Library of Medicine.