HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed touse RECARBRIO safely and effectively. See full prescribinginformation 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 betalactamaseinhibitor, indicated in patients 18 years of age and older whohave limited or no alternative treatment options, for the treatment of thefollowing infections caused by susceptible gram-negative bacteria:
Complicated urinary tract infections, including pyelonephritis(cUTI) (1.1)
Complicated intra-abdominal infections (cIAI) (1.2)
Approval of these indications is based on limited clinical safety andefficacy data for RECARBRIO. (1.1, 1.2, 14)
To reduce the development of drug-resistant bacteria and maintain theeffectiveness of RECARBRIO and other antibacterial drugs,RECARBRIO should be used only to treat or prevent infections that areproven or strongly suspected to be caused by bacteria. (1.3)
DOSAGE AND ADMINISTRATION
Administer RECARBRIO 1.25 grams (imipenem 500 mg, cilastatin500 mg, relebactam 250 mg) by intravenous (IV) infusion over30 minutes every 6 hours in patients 18 years of age and olderwith 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, cilastatin
400 mg, and relebactam 200 mg
30 to 59
0.75 grams (imipenem 300 mg,
cilastatin 300 mg, and relebactam
150 mg
15 to 29
0.5 grams (imipenem 200 mg,
cilastatin 200 mg, and relebactam
100 mg
End Stage Renal Disease
on Hemodialysis
0.5 grams (imipenem 200 mg,
cilastatin 200 mg, and relebactam
100 mg
*CLcr calculated using the Cockroft-Gault formula.
Patients with CLcr less than 15 mL/min should not receiveRECARBRIO unless hemodialysis is instituted within 48 hours.(2.2)
See Full Prescribing Information for instructions for constitutingsupplied dry powder and subsequent required dilution. (2.3, 2.4)
See Full Prescribing Information for drug incompatibilities. (2.6)
DOSAGE FORMS AND STRENGTHS
RECARBRIO 1.25 grams for injection is supplied as sterile powder forconstitution in a single-dose vial containing imipenem 500 mg(anhydrate equivalent), cilastatin 500 mg (free acid equivalent), andrelebactam 250 mg (anhydrate equivalent). (3)
CONTRAINDICATIONS
RECARBRIO is contraindicated in patients with a history of knownsevere hypersensitivity to any component of RECARBRIO. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity reactions have beenreported in patients receiving beta lactam drugs. DiscontinueRECARBRIO immediately if ahypersensitivity reaction occurs.(5.1)
Seizures and Central Nervous System Adverse Reactions: CNSadverse reactions such as seizures have been reported withimipenem/cilastatin, a component of RECARBRIO. If focaltremors, myoclonus, or seizures occur, eva luate patients, todetermine whether RECARBRIO should be discontinued. (5.2)
Increased Seizure Potential Due to Interaction with Valproic Acid:Conco |
