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HIGHLIGHTS of PRESCRIBING INFORMATION These Highlights Do HIGHLIGHTS OF PRESCRIBING INFORMATION • See Full Prescribing Information for instructions for constituting These highlights do not include all the information needed to use supplied dry powder and subsequent required dilution. (2.3, 2.4) RECARBRIO safely and effectively. See full prescribing • See Full Prescribing Information for drug incompatibilities. (2.6) information for RECARBRIO. --------------------- DOSAGE FORMS AND STRENGTHS --------------------­ RECARBRIO™ (imipenem, cilastatin, and relebactam) for injection, RECARBRIO 1.25 grams for injection is supplied as sterile powder for for intravenous use constitution in a single-dose vial containing imipenem 500 mg Initial U.S. Approval: 2019 (anhydrate equivalent), cilastatin 500 mg (free acid equivalent), and relebactam 250 mg (anhydrate equivalent). (3) ----------------------------INDICATIONS AND USAGE ---------------------------­ RECARBRIO is a combination of imipenem, a penem antibacterial, ------------------------------- CONTRAINDICATIONS ------------------------------­ cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta­ RECARBRIO is contraindicated in patients with a history of known lactamase inhibitor, indicated in patients 18 years of age and older who severe hypersensitivity to any component of RECARBRIO. (4) have limited or no alternative treatment options, for the treatment of the following infections caused by susceptible gram-negative bacteria: ----------------------- WARNINGS AND PRECAUTIONS ----------------------­ • Complicated urinary tract infections, including pyelonephritis (cUTI) • Hypersensitivity Reactions: Hypersensitivity reactions have been (1.1) reported in patients receiving beta lactam drugs. Discontinue • Complicated intra-abdominal infections (cIAI) (1.2) RECARBRIO immediately if a hypersensitivity reaction occurs. Approval of these indications is based on limited clinical safety and (5.1) efficacy data for RECARBRIO. (1.1, 1.2, 14) • Seizures and Central Nervous System Adverse Reactions: CNS adverse reactions such as seizures have been reported with To reduce the development of drug-resistant bacteria and maintain the imipenem/cilastatin, a component of RECARBRIO. If focal tremors, effectiveness of RECARBRIO and other antibacterial drugs, myoclonus, or seizures occur, evaluate patients, to determine RECARBRIO should be used only to treat or prevent infections that are whether RECARBRIO should be discontinued. (5.2) proven or strongly suspected to be caused by bacteria. (1.3) • Increased Seizure Potential Due to Interaction with Valproic Acid: Concomitant use of RECARBRIO with valproic acid or divalproex ----------------------- DOSAGE AND ADMINISTRATION ----------------------­ sodium may reduce the serum concentration of valproic acid which • Administer RECARBRIO 1.25 grams (imipenem 500 mg, cilastatin may increase the risk of breakthrough seizures. Avoid concomitant 500 mg, relebactam 250 mg) by intravenous (IV) infusion over use or consider alternative antibacterial drugs other than 30 minutes every 6 hours in patients 18 years of age and older with carbapenems. (5.3, 7.2) creatinine clearance (CLcr) 90 mL/min or greater. (2.1) • Clostridium difficile-Associated Diarrhea (CDAD): Has been • Dosage adjustment in patients with renal impairment. (2.2) reported with imipenem/cilastatin plus relebactam. Evaluate if Recommended Dose of diarrhea occurs. (5.4) RECARBRIO Estimated Creatinine (imipenem/cilastatin/relebactam) ------------------------------ ADVERSE REACTIONS -----------------------------­ Clearance (mL/min)* (mg) administered by IV infusion The most frequently reported adverse reactions occurring in greater over 30 minutes every 6 hours than or equal to 2 % of patients treated with imipenem/cilastatin plus 1 gram (imipenem 400 mg, cilastatin relebactam 250 mg were diarrhea, nausea, headache, vomiting, alanine 60 to 89 400 mg, and relebactam 200 mg aminotransferase increased, aspartate aminotransferase increased, 0.75 grams (imipenem 300 mg, phlebitis/infusion site reactions, pyrexia, and hypertension. (6) 30 to 59 cilastatin 300 mg, and relebactam 150 mg To report SUSPECTED ADVERSE REACTIONS, contact Merck 0.5 grams (imipenem 200 mg, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877­ 15 to 29 cilastatin 200 mg, and relebactam 888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 100 mg 0.5 grams (imipenem 200 mg, ------------------------------- DRUG INTERACTIONS ------------------------------­ End Stage Renal Disease cilastatin 200 mg, and relebactam • Ganciclovir: Avoid concomitant use. (7.1) on Hemodialysis 100 mg • Valproic Acid or Divalproex Sodium: Avoid concomitant use. (7.2) *CLcr calculated using the Cockroft-Gault formula. See 17 for PATIENT COUNSELING INFORMATION. • Patients with CLcr less than 15 mL/min should not receive RECARBRIO unless hemodialysis is instituted within 48 hours. Revised: 07/2019 (2.2) Reference ID: 4462927 FULL PRESCRIBING INFORMATION: CONTENTS* 6.1 Clinical Trials Experience 1 INDICATIONS AND USAGE 7 DRUG INTERACTIONS 1.1 Complicated Urinary Tract Infections (cUTI), including 7.1 Ganciclovir Pyelonephritis 7.2 Valproic Acid 1.2 Complicated Intra-abdominal Infections (cIAI) 8 USE IN SPECIFIC POPULATIONS 1.3 Usage 8.1 Pregnancy 2 DOSAGE AND ADMINISTRATION 8.2 Lactation 2.1 Recommended Dosage in Adults 8.4 Pediatric Use 2.2 Dosage Adjustments in Patients with Renal Impairment 8.5 Geriatric Use 2.3 Preparation of RECARBRIO Solution for Intravenous 8.6 Renal Impairment Administration 10 OVERDOSAGE 2.4 Preparation of RECARBRIO Solution for Intravenous 11 DESCRIPTION Administration in Patients with Renal Impairment 12 CLINICAL PHARMACOLOGY 2.5 Storage of Constituted Solution 12.1 Mechanism of Action 2.6 Incompatible Injectable Drug Products 12.2 Pharmacodynamics 3 DOSAGE FORMS AND STRENGTHS 12.3 Pharmacokinetics 4 CONTRAINDICATIONS 12.4 Microbiology 5 WARNINGS AND PRECAUTIONS 13 NONCLINICAL TOXICOLOGY 5.1 Hypersensitivity Reactions 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.2 Seizures and Other Central Nervous System (CNS) Adverse 13.2 Animal Toxicology and/or Pharmacology Reactions 14 CLINICAL STUDIES 5.3 Increased Seizure Potential Due to Interaction with Valproic 16 HOW SUPPLIED/STORAGE AND HANDLING Acid 17 PATIENT COUNSELING INFORMATION 5.4 Clostridium difficile-Associated Diarrhea (CDAD) *Sections or subsections omitted from the full prescribing information 5.5 Development of Drug-Resistant Bacteria are not listed. 6 ADVERSE REACTIONS FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis RECARBRIOTM 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)]. 1.2 Complicated Intra-abdominal Infections (cIAI) RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible gram-negative microorganisms: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis, and Pseudomonas aeruginosa. Approval of this indication is based on limited clinical safety and efficacy data for RECARBRIO [see Clinical Studies (14)]. 1.3 Usage 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in Adults The recommended dosage of RECARBRIO is 1.25 grams (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) administered by intravenous (IV) infusion over 30 minutes every 6 hours in patients 18 years of age and older with creatinine clearance (CLcr) of 90 mL/min or greater. A dose reduction is recommended for patients with CLcr less than 90 mL/min (Table 1) [see Dosage and Administration (2.2)]. Reference ID: 4462927 The severity and location of infection, as well as clinical response should guide the duration of therapy. The recommended duration of treatment with RECARBRIO is 4 days to 14 days. 2.2 Dosage Adjustments in Patients with Renal Impairment Dosage adjustment is recommended in patients with renal impairment. Patients who have a CLcr less than 90 mL/min require dosage reduction of RECARBRIO (Table 1). For patients with fluctuating renal function, CLcr should be monitored. Table 1: Dosage of RECARBRIO for Adult Patients with Renal Impairment Recommended Dosage of RECARBRIO Estimated CLcr (mL/min)a (imipenem/cilastatin
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