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Now Approved

ZaynichTM (cefepime and zidebactam) for injection

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.

  • Novel Mechanism of Action

    Synergistically targets multiple penicillin binding proteins (PBP1a/b, 2 and 3)

  • Clinical Efficacy

    In the Phase 3 ENHANCE1 clinical trial, ZAYNICH™ demonstrated higher combined clinical cure and microbiologic eradication (composite endpoint) at the test of cure (TOC) visit versus meropenem, 89.0% vs 68.4% respectively and was generally well tolerated

  • Most Common Adverse Reactions

    The most common adverse reactions occurring in ≥2% of patients receiving ZAYNICH™ were diarrhea, hypertension, headache, and hypokalemia

Clinical Trial Experience: A total of 530 adults with cUTI, including pyelonephritis, were randomized in a 2:1 ratio in a multinational, double-blind, noninferiority trial (Trial 1, NCT04979806), comparing ZAYNICH (2 grams cefepime and 1 gram of zidebactam) to meropenem (1 gram) both administered intravenously every 8 hours (infused over 1 hour) for 7 to 10 days, for patients with and without bacteremia. The dose adjustments were made for patients with renal impairment. No switch from IV to oral antibacterial therapy was permitted

ZAYNICH™ (cefepime and zidebactam) for Injection

Indication and Usage

Complicated Urinary Tract Infections, Including Pyelonephritis

ZAYNICH™ is indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex, and Pseudomonas aeruginosa.

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 susceptible bacteria.

Important Safety Information

Contraindications

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.

Warnings and Precautions

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.

Positive Direct Coombs' Tests: Positive direct Coombs' tests with or without hemolysis have been reported during treatment with cefepime, a component of ZAYNICH™. In patients who develop hemolytic anemia, discontinue the drug and institute appropriate therapy.

Prolonged Prothrombin Time: Decrease in prothrombin activity has been reported for many cephalosporins including cefepime, a component of ZAYNICH™. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk, and exogenous vitamin K should be administered as indicated.

Development of Drug-Resistant Bacteria: Prescribing ZAYNICH™ in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Interactions with Urine Glucose Testing: The administration of cefepime, a component of ZAYNICH™, may result in a false-positive reaction for glucose in the urine when using some methods (e.g., Clinitest™ tablets). It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

Adverse Reactions

The most common adverse reactions occurring in ≥2% of patients receiving ZAYNICH™ were diarrhea, hypertension, headache, and hypokalemia.