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Brand Name
Zaynich
Generic Name
Cefepime
View Brand Information FDA approval date: May 01, 2008
Classification: Cephalosporin Antibacterial
Form: Injection
What is Zaynich (Cefepime)?
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 including pyelonephritis caused by designated susceptible microorganisms.
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Brand Information
ZAYNICH (zidebactam dihydrate and cefepime hydrochloride)
1DOSAGE FORMS AND STRENGTHS
ZAYNICH 3 grams (cefepime and zidebactam) for injection is supplied as a sterile white to pale yellow powder for reconstitution in a single-dose vial, containing 2 grams cefepime and 1 gram zidebactam.
2CONTRAINDICATIONS
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 [
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [
- Neurotoxicity [
- Clostridiodes difficileInfection [ see Warnings and Precautions ( ]
3.1Clinical 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,
Common Adverse Reactions
The most frequently reported adverse reactions (2% or greater) in patients receiving ZAYNICH were diarrhea, hypertension, headache, and hypokalemia.
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 disorders: 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
3.2Postmarketing 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.
4OVERDOSAGE
There is no experience with overdose of ZAYNICH. Patients who receive an overdose should be carefully observed and given supportive treatment.
Cefepime and zidebactam can be removed by hemodialysis
Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, neuromuscular excitability and nonconvulsive status epilepticus
5DESCRIPTION
ZAYNICH for injection contains cefepime hydrochloride, a cephalosporin antibacterial drug, and zidebactam, a beta-lactamase inhibitor and non-beta-lactam antibacterial.
Cefepime, present as cefepime hydrochloride monohydrate, is a white to pale yellow powder. The chemical name for cefepime hydrochloride monohydrate is 1-[[(6
Figure 1. Cefepime Hydrochloride
The molecular formula of cefepime hydrochloride monohydrate is C
Zidebactam is a white to pale yellow powder. The chemical name of zidebactam is (2
Figure 2. Zidebactam
Zidebactam is freely soluble in water. Its molecular formula is C
ZAYNICH 3 grams (cefepime and zidebactam) for injection is supplied as a white to pale yellow sterile powder for reconstitution. Each vial contains 2 grams of cefepime (equivalent to 2.3 grams of cefepime hydrochloride), 1 gram of zidebactam, and 1.4 grams of L-arginine.
6HOW SUPPLIED/STORAGE AND HANDLING
ZAYNICH 3 grams (cefepime and zidebactam) for injection is supplied as a white to pale yellow sterile powder for reconstitution. It is packed in a clear USP Type I glass single-dose vial with a rubber stopper (not made with natural rubber latex) and flip-off seal.
Each single-dose vial contains 2 grams of cefepime and 1 gram of zidebactam.
7PATIENT COUNSELING INFORMATION
Serious Allergic Reactions
Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Advise patients to discontinue ZAYNICH and seek immediate medical attention if allergic reactions occur
Neurotoxicity
Advise patients of neurological adverse reactions that could occur with ZAYNICH use. Instruct patients or their caregivers to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), aphasia (disturbance of speaking and understanding spoken and written language), myoclonus, seizures and nonconvulsive status epilepticus
Potentially Serious Diarrhea
Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterial drug is discontinued. Inform patients that they may develop watery and bloody stools (with or without stomach cramps and fever) during treatment and as late as two or more months after having taken the last dose of the antibacterial drug. Inform patients that they should contact their physician as soon as possible if this occurs
Antibacterial Resistance
Counsel patients that antibacterial drugs, including ZAYNICH, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). Patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed
Manufactured by:
ACS Dobfar S.p.A.
Via Alessandro Fleming 2
Verona 37135, Italy
Manufactured for:
Wockhardt Suisse USA LLC
200 Continental DR STE 401
Newark, DE 19713-4337, USA
06/2026
8PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
VIAL LABEL
NDC: 87706-866-00
single-dose vial
Zaynich™ 3 g per vial*
(cefepime and zidebactam)
for injection
For intravenous infusion
after reconstitution and dilution
Rx only
WOCKHARDT
MONO CARTON
NDC: 87706-866-01
1 single-dose vial
Zaynich™ 3 g per vial*
(cefepime and zidebactam)
for injection
For intravenous infusion
after reconstitution and dilution
Rx only
WOCKHARDT
