Meropenem and Vaborbactam

VABOMERE (meropenem and vaborbactam) is a combination of meropenem, a penem antibacterial, and vaborbactam, a beta-lactamase inhibitor, indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.1.

VABOMERE is an antibacterial drug.

Administer VABOMERE 4 grams (meropenem 2 grams and vaborbactam 2 grams) every 8 hours by intravenous infusion over 3 hours for up to 14 days, in patients 18 years of age and older with an estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m 2. Dosage adjustment is recommended in patients with renal impairment who have an eGFR less than 50 mL/min/ 1.73m 2. eGFR As calculated using the Modification of Diet in Renal Disease (MDRD) formula, (mL/min/ 1.73m 2 ) Recommended Dosage Regimen for VABOMERE (meropenem and vaborbactam) All doses of VABOMERE are administered intravenously over 3 hours,, Doses adjusted for renal impairment should be administered after a hemodialysis session,, The total duration of treatment is for up to 14 days.

VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs. Known hypersensitivity to the components of VABOMERE (meropenem and vaborbactam) or anaphylactic reactions to beta-lactams.

Hypersensitivity reactions were reported with the use of VABOMERE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Discontinue infusion if signs of acute hypersensitivity occur. Seizures and other adverse Central Nervous System experiences have been reported during treatment with meropenem, a component of VABOMERE. Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue VABOMERE and initiate appropriate therapy. Clostridioides difficile -associated diarrhea has been reported with nearly all systemic antibacterial agents, including VABOMERE. Evaluate patients if diarrhea occurs. Co-administration of meropenem with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures.

The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions Seizure Potential Rhabdomyolysis Clostridioides difficile -associated Diarrhea Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid Thrombocytopenia Potential for Neuromotor Impairment Development of Drug-Resistant Bacteria Overgrowth of Non-susceptible Organisms The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea.

Hormonal Contraceptives: Effectiveness may be reduced, use an effective alternative non-hormonal form of contraception or additional contraceptive method.

Store VABOMERE vials at 20°C to 25°C (68°F to 77°F), excursions are permitted to 15°C to 30°C (59°F to 86°F).