RECARBRIO- imipenem anhydrous, cilastatin, and relebactam anhydrous injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IMIPENEM ANHYDROUS (UNII: Q20IM7HE75) (IMIPENEM ANHYDROUS - UNII:Q20IM7HE75), CILASTATIN (UNII: 141A6AMN38) (CILASTATIN - UNII:141A6AMN38), RELEBACTAM ANHYDROUS (UNII: 1OQF7TT3PF) (RELEBACTAM ANHYDROUS - UNII:1OQF7TT3PF)

Available from:

Merck Sharp & Dohme LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

RECARBRIO™ is indicated for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible gram-negative microorganisms: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae , Escherichia coli , Haemophilus influenzae , Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens. RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible gram-negative microorganisms: Enterobacter cloacae , Escherichia coli , Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa . Approval of this indication is based on limited clinical safety and efficacy data for RECARBRIO [see Clinical Studies (14.2)] . RECARBRIO is indicated in patients

Product summary:

RECARBRIO (imipenem, cilastatin, and relebactam) for injection, 1.25 grams is supplied as a white to light yellow sterile powder for constitution in a single-dose glass vial containing imipenem 500 mg (equivalent to 530 mg imipenem monohydrate), cilastatin 500 mg (equivalent to 531 mg cilastatin sodium), and relebactam 250 mg (equivalent to 263 mg relebactam monohydrate). The vials are supplied as a single-dose glass vial (NDC 0006-3856-01) and in cartons containing 25 vials (NDC 0006-3856-02). Store RECARBRIO vials at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F) [see USP Controlled Room Temperature]. Keep vials in the carton.

Authorization status:

New Drug Application

Summary of Product characteristics

RECARBRIO- IMIPENEM ANHYDROUS, CILASTATIN, AND RELEBACTAM
ANHYDROUS INJECTION, POWDER, FOR SOLUTION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RECARBRIO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RECARBRIO.
RECARBRIO™ (IMIPENEM, CILASTATIN, AND RELEBACTAM) FOR INJECTION, FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2019
INDICATIONS AND USAGE
RECARBRIO is a combination of imipenem, a penem antibacterial,
cilastatin, a renal dehydropeptidase
inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in
patients 18 years of age and older 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. (1.2)
Complicated intra-abdominal infections (cIAI) in patients who have
limited or no alternative treatment
options. (1.3)
Approval of the cUTI and cIAI indications is based on limited clinical
safety and efficacy data for RECARBRIO.
(1.2, 1.3, 14)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of RECARBRIO and
other antibacterial drugs, RECARBRIO should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria. (1.3)
DOSAGE AND ADMINISTRATION
Administer RECARBRIO 1.25 grams (imipenem 500 mg, cilastatin 500 mg,
relebactam 250 mg) by
intravenous (IV) infusion over 30 minutes every 6 hours in patients 18
years of age and older with
creatinine clearance (CLcr) 90 mL/min or greater. (2.1)
Dosage adjustment in patients with renal impairment. (2.2)
ESTIMATED CREATININE CLEARANCE
(ML/MIN)
RECOMMENDED DOSE OF RECARBRIO
(IMIPENEM/CILASTATIN/RELEBACTAM) (MG) ADMINISTERED
BY IV INFUSION OVER 30 MINUTES EVERY 6 HOURS
*
60 to 89
1 gram (imipenem 400 mg, cilastat