RECARBRIO

Generic Name/API: imipenem, cilastatin, and relebactam

Manufacturer: Merck Sharp & Dohme LLC

Dosage Forms & Strength & Pack Size:
RECARBRIO 1.25 grams for injection is supplied as sterile powder for constitution in a single-dose vial containing imipenem 500 mg (anhydrate equivalent), cilastatin 500 mg (free acid equivalent), and relebactam 250 mg (anhydrate equivalent).

Storage:
Store at 20°C to 25C (68°F to 77°F).

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
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)

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity 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)

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