Zerbaxa

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Zerbaxa

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Zerbaxa

What is Zerbaxa?

Zerbaxa is an antibacterial prescription medicine composed of two distinct active components: ceftolozane and tazobactam. It belongs to a class of medications known as cephalosporin antibacterial combinations. This medication is designed to treat specific types of bacterial infections by targeting and eliminating the bacteria responsible for the illness.

Composition and Mechanism

The efficacy of Zerbaxa relies on the combined action of its two primary ingredients:

  • Ceftolozane: This is a cephalosporin antibiotic. It works by interfering with the ability of bacteria to form stable cell walls. By preventing the bacteria from building these protective structures, the medicine causes the bacterial cells to rupture and die.
  • Tazobactam: This component is known as a beta-lactamase inhibitor. Many bacteria produce enzymes called beta-lactamases, which can break down and deactivate antibiotics like ceftolozane. Tazobactam works by blocking these enzymes, thereby protecting the ceftolozane and allowing it to remain effective against resistant bacterial strains.

Clinical Applications

Zerbaxa is used in clinical settings to manage serious infections, particularly those suspected or proven to be caused by susceptible Gram-negative and certain Gram-positive bacteria. Its use is typically reserved for cases where the bacteria may be resistant to other common antibiotics. Common areas of application include:

  • Intra-abdominal Infections: Used in combination with other medications to treat complex infections within the abdominal cavity.
  • Urinary Tract Infections: Utilized for complicated infections of the urinary system, including cases that involve the kidneys.
  • Hospital-Acquired Pneumonia: Applied in the treatment of bacterial pneumonia developed during a hospital stay, including ventilator-associated pneumonia.

By combining a potent antibiotic with a protective agent, Zerbaxa provides a therapeutic option for addressing challenging bacterial infections that might otherwise be difficult to treat.

Regulatory References

  1. EMA Zerbaxa (ceftolozane/tazobactam) EPAR
  2. MedlinePlus Drug Information: Ceftolozane and Tazobactam

What side effects are possible with Zerbaxa?

Zerbaxa: Possible Side Effects and Safety Information

Zerbaxa (ceftolozane and tazobactam) is associated with adverse reactions that are generally consistent with the cephalosporin class of antibiotics. The most common adverse reactions (5% incidence in clinical trials for complicated infections) include nausea, diarrhea, headache, and pyrexia (fever). For patients treated for hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia (HABP/VABP), common adverse reactions also include an increase in hepatic transaminases and renal impairment/renal failure.

Serious and Clinically Significant Adverse Reactions

Regulatory warnings highlight the risk of serious hypersensitivity reactions, including anaphylaxis, which are potentially fatal and contraindicate use in patients with a history of serious allergic reactions to ceftolozane/tazobactam, piperacillin/tazobactam, or other beta-lactam antibiotics.

Another significant risk is Clostridioides difficile-associated diarrhea (CDAD), which can range from mild diarrhea to fatal colitis and requires prompt evaluation if diarrhea occurs. Additionally, rare cases of intracranial hemorrhage have been reported.

Safety Considerations and Restrictions

  • Renal Function: Zerbaxa requires dose adjustment for patients with a creatinine clearance ( CrCl) of 50 mL/min or less. Decreased clinical efficacy has been reported in patients with a baseline CrCl between 30 and leq 50 mL/min. Renal function should be monitored at least daily in patients experiencing changing renal status.
  • Age: Patients aged 65 years and older have shown a higher incidence of adverse reactions in some clinical studies.
  • Other Findings: The drug may result in a positive direct Coombs test and carries a risk of promoting the overgrowth of non-susceptible organisms (superinfection).

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information regarding Zerbaxa (Ceftolozane and Tazobactam) overdose focuses on management protocols rather than a specific set of documented symptoms.


Official Guidance on Overexposure

Documented Presentation: No specific unique symptom profile or clinical manifestations are formally documented in the Overdosage sections of official regulatory labels.

Immediate Action Mandated: Urgent medical attention must be sought immediately in the event of suspected overexposure. The required initial steps include discontinuation of the drug administration and initiation of symptomatic and supportive treatment by a healthcare professional.

Antidote Status: No specific antidote is known for Ceftolozane and Tazobactam.


Management and Elimination

Management is primarily supportive. Both active components of Zerbaxa, Ceftolozane and Tazobactam, can be partially removed from the body via haemodialysis. Official prescribing information notes that approximately two-thirds of the administered dose can be removed during a four-hour haemodialysis session. Therefore, management involves close clinical monitoring, especially of renal function, due to the drug’s primary elimination pathway.

Consult a healthcare professional or contact emergency services immediately if overexposure is suspected.

Therapeutic Uses of Zerbaxa

What Zerbaxa Treats: Main Uses and Benefits

Zerbaxa is generally used in areas where short-term symptom management is appropriate for conditions associated with severe, complicated bacterial infections in specific areas of the body. The medication generally addresses complicated intra-abdominal infections, complicated urinary tract infections, acute pyelonephritis, and hospital-acquired pneumonia.

It is commonly used in clinical settings that involve acute or unstable symptom patterns, typically when the infection has created noticeable functional strain. The medication is used for managing symptoms that create noticeable physiological strain, such as symptoms related to systemic imbalance (like high fever and chills) or symptoms linked to organ-specific functional stress (like severe pain). In these situations, Zerbaxa provides support that helps ease the overall symptom burden.

It is applied during phases where symptoms become temporarily overwhelming, and may assist with maintaining functional stability and supports general well-being by easing distress during symptomatic phases.

Quick Fact: Relief for Symptoms related to Systemic Imbalance and Localized Organ Stress.

Eligibility and Restrictions for Use

Eligibility for Zerbaxa (Ceftolozane/Tazobactam)

Use of Zerbaxa is determined by official population eligibility rules defined by regulatory authorities.

Contraindicated Populations: Zerbaxa must not be used by individuals with a known serious hypersensitivity (severe allergy) to ceftolozane/tazobactam or to any other beta-lactam antibacterial agent, such as penicillins or carbapenems. This absolute exclusion also applies to severe hypersensitivity to piperacillin/tazobactam.

Age-Based Eligibility: The medicine is approved for adults (18 years and older) for all labeled complicated infections. For pediatric patients (birth to less than 18 years), use is approved for complicated urinary tract and intra-abdominal infections, but safety and efficacy are not established for hospital-acquired pneumonia.

Condition-Based Restrictions: Eligibility is constrained by renal function. Adult patients with moderate or severe renal impairment or those on hemodialysis may use Zerbaxa, but require a mandatory dose adjustment. However, use is not recommended for pediatric patients with moderate or severe renal impairment due to insufficient dosing data. Use is permitted for patients with hepatic impairment without dose change.

Pregnancy and Lactation: Use during pregnancy and lactation is conditional. The medicine should only be used if the expected benefit is determined to outweigh the possible risk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction Scope

The medicine's official interaction profile is primarily defined by its reliance on renal clearance and the activity of specific kidney transport proteins. Probenecid, a substance known to inhibit Organic Anion Transporters (OATs), has been shown to increase the systemic exposure (plasma levels) of the Tazobactam component by interfering with its elimination pathway. Regulatory documents classify this as a known pharmacokinetic interaction.

No clinically significant metabolic drug interactions are anticipated, as both components have been documented to not significantly inhibit or induce major Cytochrome P450 (CYP) enzymes at therapeutic concentrations. Furthermore, no interaction warnings are documented with food, alcohol, or herbal products.

Interaction-Context Constraints

The physical administration of the product carries a restriction: the solution must not be physically admixed with or added to solutions containing other drugs due to established incompatibility.

Population-Specific and Prohibited Combinations

  • Population Notes: The clearance of both active components is reduced in patients with impaired kidney function (Creatinine Clearance le 50 mL/min). This reduced elimination rate results in increased drug exposure and is classified as a population-dependent factor affecting drug levels.
  • Prohibited Combinations: The product is formally contraindicated in patients with a history of severe hypersensitivity to any cephalosporin or any other beta-lactam antibacterial agent (e.g., penicillins or carbapenems).

Mechanism of Action

Direct Disruption of Bacterial Structural Integrity

This domain covers the primary role of Ceftolozane, which is immediate interference with the pathogen's viability. The drug achieves a bactericidal effect by covalently inhibiting crucial Penicillin-Binding Proteins (PBPs), thereby preventing the necessary peptidoglycan cross-linking required for a stable bacterial cell wall. This molecular action initiates an irreversible lysis cascade where the cell ruptures due to osmotic pressure, resulting in the lysis and termination of susceptible organisms.

️ Mechanistic Disarmament of Resistance Enzymes

This block addresses the essential synergistic role of Tazobactam, which focuses on the chemical neutralization of bacterial resistance factors. Tazobactam acts as a suicide inhibitor by binding irreversibly to and inactivating key β-lactamase enzymes (Ambler Class A/C). This protects Ceftolozane from enzymatic destruction, potentiating its PBP-inhibiting action. This action increases the spectrum of bacterial enzyme systems susceptible to Ceftolozane's PBP-targeting mechanism.

Evasion of Pathogen-Specific Defense Systems

This domain describes the mechanisms that confer Ceftolozane's activity toward pathogens such as Pseudomonas aeruginosa. The molecule exhibits a strong binding affinity for the PBPs of this organism, and its structural ability to bypass multiple resistance factors, such as efflux pump systems and restrictive outer membrane porin channels, contribute to the consistent bactericidal effect against strains that express mechanisms of multi-drug resistance.

Dosage and Administration Information

How Zerbaxa is Used: Official Administration Guidelines

Zerbaxa (ceftolozane and tazobactam) is used exclusively in a supervised clinical setting, as it is administered only via intravenous (IV) infusion. The medicine is supplied as a sterile powder in a single-use vial, requiring initial reconstitution and then further dilution in an infusion solution (such as 0.9% Sodium Chloride) before it can be administered. The entire infusion process is standardized to occur over a 1-hour period and is repeated every 8 hours for the full course of treatment.


Standard Dosing and Treatment Duration

The required dose and the total duration of use are determined by the specific type of complicated infection being treated. The standard adult dose applies to patients with adequate kidney function (Creatinine Clearance, CrCl > 50 mL/min). The following regimens represent standard dosing instructions.

Indication Standard Dose (Ceftolozane/Tazobactam) Treatment Duration
Complicated Urinary Tract Infections (cUTI) 1.5 g (1 g/0.5 g) 7 days
Complicated Intra-abdominal Infections (cIAI) 1.5 g (1 g/0.5 g) 4 to 14 days
Hospital-acquired/Ventilator-associated Pneumonia (HABP/VABP) 3 g (2 g/1 g) 8 to 14 days

For cIAI, Zerbaxa is used in conjunction with metronidazole to address specific pathogens.


Population-Specific Adjustments

Official instructions mandate dose adjustment for adult patients with moderate to severe renal impairment (a CrCl <= 50 mL/min) or those undergoing hemodialysis. The precise dose must be mathematically reduced based on the estimated CrCl value to prevent drug accumulation. For pediatric patients (birth to <18 years) with adequate kidney function, dosing is determined by body weight, up to a maximum of the adult dose for cUTI and cIAI.

Recent Clinical Evidence

Zerbaxa: Recent Clinical Evidence

Zerbaxa (ceftolozane and tazobactam) is an antibacterial combination product used in the treatment of serious infections caused by susceptible Gram-negative bacteria. Regulatory approval was granted following large, global Phase 3 clinical trials that primarily focused on non-inferiority compared to established treatments.


Key Areas of Study

  • Complicated Urinary Tract Infections (cUTI): Clinical studies for cUTI, including pyelonephritis, evaluated outcomes against a comparator drug. The primary analysis examined a composite endpoint of microbiological eradication and clinical cure. Studies demonstrated that the clinical response was comparable to the comparator in the overall population studied.

  • Complicated Intra-abdominal Infections (cIAI): Trials for cIAI, where Zerbaxa was used in combination with metronidazole, evaluated clinical cure rates against another comparator drug (meropenem). Results from these studies indicated that the outcomes were non-inferior in the main population analyzed.

  • Hospital-Acquired and Ventilator-Associated Pneumonia (HABP/VABP): Subsequent research, including the ASPECT-NP trial, examined the use of Zerbaxa for adult patients with nosocomial pneumonia. The study's main endpoints examined all-cause mortality and clinical response at the test-of-cure visit. The data showed non-inferiority of the clinical response compared to the comparator (meropenem).


Focus on Specific Patient Groups

Research has explored the use of Zerbaxa in patients with multidrug-resistant (MDR) Pseudomonas aeruginosa and Extended-Spectrum Beta-Lactamase (ESBL)-producing Enterobacterales. Studies show that the combination is active against a range of these highly resistant pathogens.

Studies also examined outcomes in patients with renal impairment. A decreased clinical response rate was observed in some trials among patients with a creatinine clearance ( CrCl) of 30 to le 50 mL/ min compared to those with CrCl > 50 mL/ min.

Key Studies & References

  1. Ceftolozane/Tazobactam for Nosocomial Pneumonia: ASPECT-NP Trial Results

Frequently Asked Questions (FAQ)

Common questions about Zerbaxa (FAQ)


Q: Is Zerbaxa considered a new generation antibiotic?

A: Regulatory documents describe Zerbaxa as a combination drug containing ceftolozane, an extended-spectrum cephalosporin antibacterial, and tazobactam, which is a beta-lactamase inhibitor. This formulation is designed to work against certain resistant Gram-negative bacteria.

Q: Is it possible to receive Zerbaxa outside of a hospital setting, such as in an outpatient clinic?

A: While Zerbaxa is typically administered in a hospital setting due to the serious nature of the infections it treats, official information indicates that its use can occur within Outpatient Parenteral Antimicrobial Therapy (OPAT) services. Its required intravenous administration ensures it is delivered in a supervised healthcare environment.

Q: Is Zerbaxa a controlled substance?

A: Official governmental sources confirm that Zerbaxa is classified as a prescription-only medicine. It is not currently designated as a controlled substance under regulatory acts like the U.S. Controlled Substances Act (CSA).

Q: Can Zerbaxa cause a severe drop in blood pressure (hypotension)?

A: Hypotension (low blood pressure) has been reported as an adverse reaction in clinical trials. Monitoring is typically part of the standard care when this medicine is administered. The product label notes that this event is considered uncommon.

Q: Is a generic version of Zerbaxa available on the market?

A: No. According to current official drug databases and patent information, a generic version of Zerbaxa (ceftolozane/tazobactam) is not currently available in the United States or the European Union.

Q: What is the difference between ceftolozane and ceftazidime?

A: Ceftolozane is officially classified as an extended-spectrum cephalosporin. Regulatory and in vitro data indicate that the ceftolozane component of Zerbaxa, when combined with tazobactam, is noted to have potent activity against certain resistant bacterial strains, particularly Pseudomonas aeruginosa, compared to ceftazidime.

Q: Can patients who have received other antibiotics in the past still be treated with Zerbaxa?

A: Regulatory guidelines describe that to help maintain the effectiveness of Zerbaxa and other antibacterial drugs, the medicine is intended to be used only for infections that are proven or strongly suspected to be caused by susceptible bacteria. This standard practice is intended to minimize the risk of developing resistance.

Q: How quickly does Zerbaxa clear out of the body in a patient with normal kidney function?

A: Pharmacokinetic data from official sources indicate the medicine clears from the body relatively quickly in patients with normal kidney function. The half-life, which is the time it takes for half the drug to be eliminated, is approximately 2.77 hours for ceftolozane and approximately 0.91 hours for tazobactam.

Q: Are there any specific safety precautions for patients with a history of seizures when using Zerbaxa?

A: The official product labeling notes that seizures and other central nervous system effects have occurred with the use of this class of antibiotics (beta-lactams). As with this class of antibiotics, monitoring for central nervous system effects is a standard procedure during administration.

Q: Can the administration of Zerbaxa cause irritation or inflammation at the IV site (phlebitis)?

A: Yes, infusion site reactions are reported in the official adverse reactions section. Venous thrombosis (a blood clot in the vein) and other signs of local irritation or inflammation (phlebitis) have been noted as uncommon side effects.

Q: What is the purpose of the liquid (diluent) used to mix Zerbaxa for IV administration?

A: Zerbaxa is supplied as a sterile powder. A diluent, such as sterile water or 0.9% Sodium Chloride solution, is first used to reconstitute the powder, dissolving it completely. The solution is then further diluted before being slowly infused into the vein over one hour.

Q: What does 'ventilator-associated bacterial pneumonia' (VABP) mean in relation to Zerbaxa's use?

A: VABP is an official indication for Zerbaxa, meaning it is approved for this type of infection. VABP is described as a serious lung infection that develops in hospitalized patients who are receiving breathing support from a mechanical ventilator.

Q: Does Zerbaxa affect blood cell components, such as causing a low neutrophil count (neutropenia)?

A: Regulatory information indicates that changes in certain blood cell components have been observed. For instance, increases in platelets (thrombocytosis) and decreases in red blood cells (anemia) have been noted in clinical studies, particularly in pediatric patients.

Q: What is the risk of developing a fungal infection (like candidiasis) while on Zerbaxa?

A: Like many antibiotics, Zerbaxa can potentially alter the body's natural flora. The official adverse reaction data includes infections, such as candidiasis (yeast/fungal infection) and fungal urinary tract infection, as uncommon events.

How should Zerbaxa be stored and disposed of?

The sterile powder for injection, Zerbaxa (ceftolozane and tazobactam), must be stored according to official regulatory specifications to maintain product integrity.


Storage Conditions

Product Form Temperature Range Stability Period
Unconstituted Vial 20 C to 25 C (68 F to 77 F) Until Expiry Date
Diluted Solution 2 C to 8 C (Refrigerated) 7 Days
Diluted Solution 20 C to 25 C (Room Temp) 24 Hours

The vial should be stored in the original container and must always be kept out of the reach of children. A critical constraint is that the product must not be frozen at any point. Once reconstituted, the solution must be diluted within 1 hour.


Disposal Instructions

Any unused portion of the reconstituted or diluted solution must be discarded. Unused or expired medication should be disposed of in accordance with local regulatory requirements for pharmaceutical waste and must not be thrown into wastewater or household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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