RECARBRIO

RECARBRIO- imipenem anhydrous, cilastatin and relebactam anhydrous injection, powder, for solution
Merck Sharp & Dohme Corp.

1 INDICATIONS AND USAGE

1.1 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP)

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.

1.2 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis

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)].

1.3 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 (14.2)].

1.4 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)]. 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
Estimated CLcr (mL/min)* Recommended Dosage of RECARBRIO (imipenem/cilastatin and relebactam) (mg) Dosing Interval
RECARBRIO is provided as a single vial in a fixed-dose combination; the dose for each component will be adjusted equally during preparation [see Dosage and Administration (2.4)].
*
CLcr calculated using the Cockcroft-Gault formula
Administer by IV over 30 minutes.
Administration should be timed to follow hemodialysis.
60 to 89 1 gram (imipenem 400 mg, cilastatin 400 mg, and relebactam 200 mg) Every 6 hours
30 to 59 0.75 grams (imipenem 300 mg, cilastatin 300 mg, and relebactam 150 mg) Every 6 hours
15 to 29 0.5 grams (imipenem 200 mg, cilastatin 200 mg, and relebactam 100 mg) Every 6 hours
End Stage Renal Disease (ESRD) on Hemodialysis 0.5 grams (imipenem 200 mg, cilastatin 200 mg, and relebactam 100 mg) Every 6 hours

Patients with CLcr less than 15 mL/min should not receive RECARBRIO unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of RECARBRIO for patients undergoing peritoneal dialysis.

Imipenem, cilastatin, and relebactam are cleared from the circulation during hemodialysis. For patients maintained on hemodialysis, administer RECARBRIO after hemodialysis and at intervals timed from the end of that hemodialysis session.

2.3 Preparation of RECARBRIO Solution for Intravenous Administration

RECARBRIO is supplied as a dry powder in a single-dose vial that must be constituted and further diluted using aseptic technique prior to intravenous infusion. To prepare the infusion solution, contents of the vial must be constituted with the appropriate diluent as instructed below. A list of appropriate diluents is as follows:

  • 0.9% Sodium Chloride Injection, USP
  • 5% Dextrose Injection, USP
  • 5% Dextrose Injection, USP + 0.9% Sodium Chloride Injection, USP
  • 5% Dextrose Injection, USP + 0.45% Sodium Chloride Injection, USP
  • 5% Dextrose Injection, USP + 0.225% Sodium Chloride Injection, USP

RECARBRIO has low aqueous solubility. To ensure complete dissolution of RECARBRIO it is important to adhere to the following instructions:

Step 1) For diluents available in 100 mL prefilled infusion bags, proceed to step 2. For diluents not available in 100 mL prefilled infusion bags, aseptically withdraw 100 mL of the desired diluent and transfer it to an empty infusion bag, then proceed to step 2.
Step 2) Withdraw 20 mL (as two 10 mL aliquots) of diluent from the appropriate infusion bag and constitute the vial with one 10 mL aliquot of the diluent. The constituted suspension is for intravenous infusion only after dilution in an appropriate infusion solution.
Step 3) After constitution, shake vial well and transfer resulting suspension into the remaining 80 mL of the infusion bag.
Step 4) Add the second 10 mL aliquot of infusion diluent to the vial and shake well to ensure complete transfer of vial contents; repeat transfer of the resulting suspension to the infusion solution before administering. Agitate the resulting mixture until clear.

Constituted solutions of RECARBRIO range from colorless to yellow. Variations of color within this range do not affect the potency of the product.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if discoloration or visible particles are observed.

The above instructions for preparation of RECARBRIO solution for intravenous administration must be followed for all patients, irrespective of the intended patient’s renal function. The volume of this prepared RECARBRIO solution to be administered to patients is determined based on renal function [see Dosage and Administration (2.4)].

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