Cefepime and Zidebactam

ZAYNICH is a combination of cefepime, a cephalosporin antibacterial, and zidebactam, a beta-lactamase inhibitor and non-beta-lactam antibacterial indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZAYNICH and other antibacterial drugs, ZAYNICH should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Cefepime and zidebactam, components of ZAYNICH, are antibacterial drugs.

Recommended dosage is ZAYNICH 3 grams (2 grams cefepime and 1 gram zidebactam) every 8 hours by intravenous infusion over 1 hour for 7 to 10 days in adult patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 60 mL/min. Dosage adjustment is recommended in adult patients with renal impairment who have an eGFR less than 60 mL/min. Administer each intravenous infusion over 1 hour for patients with renal impairment. Recommended Dosage of ZAYNICH in Adult Patients with Renal Impairment eGFR As calculated using 4-variable Modification of Diet in Renal Disease (MDRD) formula. (mL/min) Dose The total duration of treatment is for 7 to 10 days. Dosing Interval 60 to 89 ZAYNICH 3 grams Provides 2 grams cefepime and 1 gram zidebactam. Every 8 hours 30 to 59 ZAYNICH 1.5 grams Provides 1 gram cefepime and 0.5 grams zidebactam.

ZAYNICH is contraindicated in patients with a known history of serious hypersensitivity to the components of ZAYNICH (cefepime and zidebactam) or other beta-lactam antibacterial drugs.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with ZAYNICH. If an allergic reaction to ZAYNICH occurs, discontinue the drug and institute appropriate supportive measures. Neurotoxicity: Neurotoxicity has been reported during treatment with cefepime, a component of ZAYNICH. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment of cefepime. If neurotoxicity occurs, discontinue ZAYNICH and institute appropriate supportive measures. Clostridioides difficile Infection: Clostridioides difficile infection has been reported with nearly all systemic antibacterial agents, including ZAYNICH. Evaluate if diarrhea occurs.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Neurotoxicity Clostridiodes difficile Infection The most common adverse reactions occurring in ≥ 2% of patients treated with ZAYNICH were diarrhea, headache, hypertension, and hypokalemia.

Aminoglycosides Monitor renal function if aminoglycosides are to be administered with ZAYNICH because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs.

Store ZAYNICH vials refrigerated at 2°C to 8°C (36°F to 46°F), brief excursions are permitted up to 25°C (77°F). Storage after reconstitution and dilution and administration instructions are described elsewhere in the labeling.