Zaynich

Zaynich is used to treat complicated urinary tract infections (cUTI) in adults, including pyelonephritis caused by susceptible organisms. Zaynich is a combination antibiotic containing cefepime and zidebactam administered by intravenous infusion every 8 hours in those with good kidney function.

• Zaynich (cefepime and zidebactam) should only be used for confirmed or suspected bacterial infections to prevent antibiotic resistance.

Zaynich combines cefepime (a fourth-generation cephalosporin antibiotic) and zidebactam (a beta-lactamase inhibitor and non-beta-lactam antibacterial) to target multiple bacterial proteins at the same time, overcoming common resistance mechanisms in hard-to-treat Gram-negative pathogens. In the Phase 3 ENHANCE-1 clinical trial, Zaynich achieved an 89% response rate versus 68.4% for meropenem.

Zaynich (cefepime and zidebactam) received FDA approval on May 29, 2026.

Zaynich is given by intravenous (IV) infusion over one hour by a healthcare provider for a total treatment course of 7 to 10 days.

Do not receive Zaynich if you have had a serious allergic reaction to cefepime, zidebactam, or any other beta-lactam antibiotic, such as penicillins or carbapenems.

Before receiving Zaynich, tell your healthcare provider about all of your medical conditions, including if you:

• Have kidney problems. Your dose of Zaynich will need to be adjusted based on how well your kidneys are working. This is particularly important in older adults, who are at higher risk of serious neurological side effects if the dose is not appropriately reduced.
• Have a history of neurological conditions, seizures, or any condition affecting the brain or nervous system.
• Have a history of diarrhoea following antibiotic use, or have had a Clostridioides difficile (C. diff) infection in the past.
• Are on dialysis. Your dose will be adjusted and should be taken after your dialysis session on dialysis days.
• Are pregnant or plan to become pregnant. Tell your healthcare provider before receiving Zaynich.
• Are breastfeeding or plan to breastfeed. Discuss the risks and benefits with your healthcare provider before receiving Zaynich.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as some medicines may interact with Zaynich.

Common Side Effects

The most common side effects of Zaynich are:

• Diarrhea
• Headache
• High blood pressure (hypertension)
• Low potassium levels (hypokalemia).

Serious Side Effects and Warnings

Zaynich may cause the following serious side effects:

• Serious Allergic Reactions. Allergic reactions, including serious allergic reactions, can occur with Zaynich that require immediate treatment. Seek immediate medical attention and do not receive any more Zaynich infusions if you develop an allergic reaction.
• Neurotoxicity. Neurological side effects can occur with Zaynich. Tell your healthcare provider immediately if you develop 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.
• Potentially Serious Diarrhea. Clostridium difficile infection causes serious diarrhea, and this infection has been reported with almost all antibacterial agents. You may develop watery and bloody stools (with or without stomach cramps and fever) during treatment with Zaynich and up to two or more months after having taken the last dose Tell your healthcare provider immediately if this occurs.
• Antibacterial Resistance. Antibacterial drugs, including Zaynich, should only be used to treat bacterial infections. They do not treat viral infections (such as the common cold). Although it is common to feel better early in the course of therapy, you should take Zaynich exactly as directed and finish the course.

These are not all of the possible side effects of Zaynich. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dose of Zaynich for Complicated Urinary Tract Infections (cUTI)

• Adults: 3 grams every 8 hours.

Kidney impairment

The dose is reduced in people with kidney impairment, based on their estimated glomerular filtration rate (eGFR):

For people on dialysis, the dose should be given after each dialysis session. On non-dialysis days, the dose is given 24 hours after the previous dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• In laboratory testing, neither cefepime nor zidebactam, the components of Zaynich, inhibited or induced key liver enzymes (CYP450) or membrane transport proteins, suggesting a low risk of interactions with other commonly used medications.

Your healthcare provider can tell you if it is safe to take Zaynich with other medicines. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Zaynich. Do not start taking a new medicine without telling your healthcare provider.

Zaynich is manufactured by ACS Dobfar S.p.A., Via Alessandro Fleming 2, Verona 37135, Italy, for Wockhardt Suisse USA LLC, 200 Continental Dr, STE 401, Newark, DE 19713-4337, USA.