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. 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 who have limited or no alternative treatment options, for the treatment of the following 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 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, 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 receive RECARBRIO unless hemodialysis is instituted within 48 hours. (2.2) �See Full Prescribing Information for instructions for constituting supplied 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 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). (3) -------------------------------CONTRAINDICATIONS------------------------------�RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO. (4) -----------------------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) �Clostridium difficile-Associated Diarrhea (CDAD): Has been reported with imipenem/cilastatin plus relebactam. Evaluate if diarrhea occurs. (5.4) ------------------------------ADVERSE REACTIONS -----------------------------�The most frequently reported adverse reactions occurring in greater than or equal to 2 % of patients treated with imipenem/cilastatin plus relebactam 250 mg were diarrhea, nausea, headache, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, phlebitis/infusion site reactions, pyrexia, and hypertension. (6) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877�888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. -------------------------------DRUG INTERACTIONS------------------------------��Ganciclovir: Avoid concomitant use. (7.1) �Valproic Acid or Divalproex Sodium: Avoid concomitant use. (7.2) See 17 for PATIENT COUNSELING INFORMATION. Revised: 07/2019
