FDA

Zaynich

Approved 29 May 2026Powder, For solutionInjection

Indications

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. ( 1.1 ) 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.

( 1.2 )

1.1Complicated 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 .

1.2Usage 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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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 [ see Warnings and Precautions ( 5.1 ) ]. 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. ( 4 )

Warnings and precautions

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. ( 5.1 ) 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.

At a glance

Brand name: Zaynich
Active substance: zidebactam and cefepime
Route: Powder, For solution
Dosage form: Injection
Applicant: Wockhardt Bio AG
Status: Prescription
FDA approval: 29 May 2026
Application: NDA220787-001

Indications

( 1.2 )

1.1Complicated Urinary Tract

1.2Usage to Reduce Development of Drug-Resistant Bacteria

Contraindications

Warnings and precautions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no data for the use of ZAYNICH, or zidebactam, a component of ZAYNICH, during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Available data from published observational studies and case reports over several decades with cephalosporin use, including cefepime, in pregnant women have not established the drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Cefepime Cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during organogenesis. The doses used in these studies were 1.6 (rats), approximately equal to (mice), and 0.3 times (rabbits) the recommended human dose of cefepime in ZAYNICH (see Data). Zidebactam Intravenous administration of zidebactam to pregnant rats during organogenesis showed no evidence of maternal or embryo-fetal toxicity at a dose of 800 mg/kg/day, approximately 5 times the recommended human dose (RHD; 1 gram zidebactam administered every 8 hours) based on plasma area under the concentration-time curve (AUC) comparison.

In pregnant rabbits, intravenous administration of zidebactam during organogenesis was associated with increased late fetal resorptions and total fetal loss in two litters at a dose of 600 mg/kg/day (approximately 5 times the RHD) and distended bladder, a fetal anomaly, at zidebactam doses greater than or equal to 300 mg/kg/day (approximately 3 times the RHD). In a pre-postnatal study, zidebactam administered intravenously to pregnant rats during organogenesis and through the lactation period was not associated with maternal toxicity or adverse effects in first- and second-generation offspring at a maternal dose of 800 mg/kg/day, approximately 5 times the RHD (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Cefepime While available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use, including cefepime, during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Available studies have methodological limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data Cefepime Cefepime was not embryocidal and did not cause fetal malformation when administered parenterally during the period of organogenesis to rats at doses up to 1000 mg/kg/day, to mice at doses up to 1200 mg/kg/day, or to rabbits at doses up to 100 mg/kg/day.

These doses are 1.6 times (rats), approximately equal to (mice), and 0.3 times (rabbits) the recommended clinical dose of cefepime in ZAYNICH based on body surface area. Zidebactam In an embryo-fetal development study in pregnant rats, zidebactam in doses of 200, 400, and 800 mg/kg/day administered intravenously in divided doses twice per day during the period of organogenesis from Gestation Day (GD) 6 to GD 17 was not associated with maternal or embryo-fetal toxicity at any dose.

The plasma zidebactam exposure for the high dose of 800 mg/kg/day was approximately 5 times the RHD based on plasma AUC comparison. Zidebactam administered to pregnant rabbits in doses of 150, 300, and 600 mg/kg/day in divided intravenous doses administered twice per day during the period of organogenesis from GD 6 to GD 18 was associated with significantly increased late fetal resorptions as well as total fetal loss in two litters at a dose of 600 mg/kg/day (approximately 5 times the RHD based on plasma AUC comparison).

Two fetuses in one litter in the mid-dose group and two fetuses in one litter in the high-dose group exhibited a fetal anomaly, distended bladder. No maternal toxicity occurred in pregnant rabbits with the 600 mg/kg/day dose of zidebactam (approximately 5 times the RHD based on plasma AUC comparison), and no embryo-fetal toxicity was observed with the 150 mg/kg/day dose (approximately 2 times the RHD based on plasma AUC comparison).

In a pre-postnatal development study, zidebactam in doses of 200, 400, and 800 mg/kg/day administered twice daily in divided doses to pregnant rats from GD 6 to Lactation Day (LD) 20 produced no maternal toxicity and did not impair the physical and behavioral development of first-generation offspring at doses up to 800 mg/kg/day. The results of the learning and memory assessment in first-generation offspring were indeterminate due to limitations of the study design.

Reproduction was not affected in first-generation offspring at zidebactam doses up to 800 mg/kg/day. The maternal dose at which no maternal toxicity and no adverse effects in first- or second-generation offspring occurred was 800 mg/kg/day corresponding to a maternal plasma AUC exposure at the end of gestation of approximately 5 times the plasma AUC exposure in humans at the RHD.

Adverse reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1 ) ] Neurotoxicity [ see Warnings and Precautions ( 5.2 ) ] Clostridiodes difficile Infection [ see Warnings and Precautions ( 5.3 ) ] The most common adverse reactions occurring in ≥ 2% of patients treated with ZAYNICH were diarrhea, headache, hypertension, and hypokalemia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wockhardt Suisse USA LLC at 1-844-367-6548 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. ZAYNICH was evaluated in a phase 3 study in patients with cUTI, including pyelonephritis (also referred to as Trial 1), which included 352 patients treated with ZAYNICH 3 grams (2 grams cefepime and 1 gram zidebactam) every 8 hours infused over 1 hour, and 177 patients treated with the comparator, meropenem, 1 gram every 8 hours, infused over 30 minutes.

Patients received treatment for 7 to 10 days. The median duration of therapy was 8 days in both treatment groups in the safety analysis set. The mean age of patients treated with ZAYNICH was 65 years and 61% of patients were 65 years of age or older. Patients were predominantly male (56%) and White (88%). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation Treatment was discontinued due to adverse reactions in 1.4% (5/352) of patients receiving ZAYNICH and in 1.1% (2/177) of patients receiving meropenem.

The adverse reactions resulting in discontinuation of ZAYNICH were anaphylactic reaction, C. difficile colitis, hyperbilirubinemia, drug hypersensitivity, and enterococcal urinary tract infection, each 0.3% (1/352). No deaths were reported. Common Adverse Reactions The most frequently reported adverse reactions (2% or greater) in patients receiving ZAYNICH were diarrhea, hypertension, headache, and hypokalemia. Table 3 lists selected adverse reactions occurring in 2% or greater of patients receiving ZAYNICH in Trial 1.

Table 3: Selected Adverse Reactions Occurring in 2% or Greater of cUTI Patients Receiving ZAYNICH in Trial 1 Trial 1 was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the ZAYNICH and the meropenem treatment groups. Adverse Reactions ZAYNICH (N=352) n (%) Meropenem (N=177) n (%) Diarrhea 15 (4) 7 (4) Hypertension Hypertension includes blood pressure inadequately controlled and hypertension. 12 (3) 3 (2) Headache 11 (3) 9 (5) Hypokalemia 10 (3) 2 (1) Other Adverse Reactions Associated with ZAYNICH The following selected adverse reactions were reported in ZAYNICH-treated patients at a rate of less than 2% in Trial 1: Blood and lymphatic system disorders: anemia, neutropenia, thrombocytopenia Gastrointestinal disorders: abdominal pain, constipation, nausea, vomiting General disorders and administration site conditions : pyrexia, infusion site reaction including injection site erythema, vascular access site hematoma Hepatobiliary disorders: hyperbilirubinemia Infections and infestations: C. difficile colitis, candida infection including oral candidiasis, genital candidiasis, candiduria Immune system disorders: allergic reaction including anaphylactic reaction, drug hypersensitivity, rash, skin burning sensation, flushing Laboratory investigations: transaminases increased including alanine aminotransferase increased, aspartate aminotransferase increased Metabolism and nutrition disorders : hyperglycemia Nervous system disorders: dizziness Psychiatric disorders: anxiety, delirium Respiratory disorders : shortness of breath Renal and urinary disorders : acute kidney injury including blood creatinine increased, blood urea nitrogen increased Vascular disorders : hypotension Other Adverse Reactions Associated with Cefepime in Other Clinical Trials Additionally, the following adverse reactions have been reported with cefepime alone in other clinical trials and are not listed above for patients treated with ZAYNICH in Trial 1: Blood and lymphatic system disorde rs: Coombs' test positive (without hemolysis), increased eosinophils, leukopenia, partial thromboplastin time prolonged, prothrombin time prolonged Infections and infestations : vaginitis Laboratory investigations : increased alkaline phosphatase, increased calcium, increased phosphorus, increased potassium, decreased calcium, decreased phosphorus Skin and subcutaneous tissue disorders : pruritus, urticaria Vascular disorders : phlebitis

6.2Postmarketing Experience

The following adverse reactions and altered laboratory tests have been identified during post approval use of cefepime (a component of ZAYNICH), or other cephalosporin-class antibacterial drugs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders : agranulocytosis, aplastic anemia, hemolytic anemia, pancytopenia Nervous system disorders : encephalopathy (including disturbance of consciousness, hallucinations, stupor, and coma), aphasia, myoclonus, seizures, and nonconvulsive status epilepticus Immune system disorders : anaphylaxis including anaphylactic shock, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis Hepatobiliary disorders : hepatic dysfunction including cholestasis Renal and urinary disorders : renal dysfunction, toxic nephropathy Vascular disorders : hemorrhage.

Zaynich

Indications

1.1Complicated Urinary Tract

1.2Usage to Reduce Development of Drug-Resistant Bacteria

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Zaynich

Indications

1.1Complicated Urinary Tract

1.2Usage to Reduce Development of Drug-Resistant Bacteria

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Hypersensitivity Reactions

5.2Neurotoxicity

5.4Positive Direct Coombs’ Tests

5.5Prolonged Prothrombin Time Decrease

5.6Development of Drug-Resistant Bacteria Prescribing

5.7Interactions with Urine Glucose Testing

Interactions

7.1Aminoglycosides

7.2Diuretics

7.3Drug/Laboratory Test Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information