ZAYNICH is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex, and Pseudomonas aeruginosa.
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 susceptible bacteria.
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. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZAYNICH is instituted, carefully inquire about previous hypersensitivity reactions to cefepime, cephalosporins, penicillins, or other beta-lactams because cross-hypersensitivity among beta-lactam antibacterial drugs has been reported. 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, including life-threatening or fatal occurrences of the following: encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), aphasia, myoclonus, seizures, and nonconvulsive status epilepticus. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment. If neurotoxicity associated with ZAYNICH therapy occurs, discontinue ZAYNICH and institute appropriate supportive measures.
Clostridioides difficile-Associated Diarrhea (CDAD): CDAD has been reported with the use of nearly all antibacterial agents including ZAYNICH and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued.