RECARBRIO

The steady-state pharmacokinetic parameters of imipenem, cilastatin, and relebactam in healthy adults with normal renal function (CLcr 90 mL/min or greater), after multiple 30-minute intravenous infusions of RECARBRIO administered every 6 hours are summarized in Table 7 . Pharmacokinetic parameters were similar for single and multiple dose administration due to minimal accumulation. Pharmacokinetic parameters in pediatric patients are described in Table 9 . Adult Patients The steady-state pharma...

14.1 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia in Adult Patients A total of 535 hospitalized adults with HABP/VABP were randomized and received trial medications in a multinational, double-blind trial (

Trial 1NCT02493764) comparing RECARBRIO 1.25 grams (imipenem 500 mg/cilastatin 500 mg/relebactam 250 mg) intravenously every 6 hours to piperacillin and tazobactam (4.5 grams) for 7 to 14 days of therapy. The modified intent-to-treat (MITT) population, which included all randomized patients who received at least one dose of trial treatment and did not ...

The following serious adverse reactions are described in greater detail in the Warnings and Precautions section. Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Seizures and Other Central Nervous System Adverse Reactions [see Warnings and Precautions (5.2) ] Increased Seizure Potential Due to Interaction with Valproic Acid [see Warnings and Precautions (5.3) ] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] Adult HABP/VABP Patients: The...

RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity (severe systemic allergic reaction such as anaphylaxis) to any component of RECARBRIO. RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO. ( 4 )

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) 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 RECAR...

7 DRUG INTERACTIONS Ganciclovir: Avoid concomitant use. ( 7.1 ) Valproic Acid or Divalproex Sodium: Avoid concomitant use. ( 7.2 ) 7.1 Ganciclovir Generalized seizures have been reported in patients who received ganciclovir concomitantly with imipenem/cilastatin, a component of RECARBRIO. Ganciclovir should not be used concomitantly with RECARBRIO unless the potential benefits outweigh the risks. ...