What is Zerbaxa used for?

Zerbaxa is indicated for the treatment of the following infections in adult and paediatric patients (see sections 4.2 and 5.1): - Complicated intra-abdominal infections (see section 4.4); - Acute pyelonephritis; - Complicated urinary tract infections (see section 4.4); Zerbaxa is also indicated for the treatment of the following infection in adult patients (18 years or older) (see section 5.1): - Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)

What is the active ingredient in Zerbaxa?

Ceftolozanum + Tazobactamum (Ceftolozanum, Tazobactamum)

What pharmaceutical form is Zerbaxa available in?

Zerbaxa: Proszek do sporządzania koncentratu roztworu do infuzji 1 g + 0,5 g (dożylna)

Is Zerbaxa OTC or prescription only?

Zerbaxa requires a doctor's prescription.

What are the side effects of Zerbaxa?

Summary of the safety profile Zerbaxa was evaluated in Phase 3 comparator-controlled clinical trials of complicated intra-abdominal infections and complicated urinary tract infections (including pyelonephritis) in adult patients. The most common adverse reactions (≥ 3% in pooled Phase 3 trials of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis) occurring in patients receiving Zerbaxa were nausea, headache, constipation, diarrhoea, and pyr

Who should NOT take Zerbaxa?

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - Hypersensitivity to any cephalosporin antibacterial agent; - Severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems).

Does Zerbaxa interact with other medications?

No significant medicinal product interactions are anticipated between ceftolozane/tazobactam and substrates, inhibitors, and inducers of cytochrome P450 enzymes (CYPs) based on in vitro and in vivo studies. In vitro studies demonstrated that ceftolozane, tazobactam and the M1 metabolite of tazobactam did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 and did not induce CYP1A2, CYP2B6, or CYP3A4 at therapeutic plasma concentrations. Ceftolozane and tazobactam were not subs

Can Zerbaxa be used during pregnancy?

Pregnancy There are no data on the use of ceftolozane/tazobactam in pregnant women. Tazobactam crosses the placenta. It is not known if ceftolozane crosses the placenta. Animal studies with tazobactam have shown reproductive toxicity (see section 5.3) without evidence of teratogenic effects. Studies with ceftolozane in mice and rats have not shown evidence of reproductive toxicity or teratogenicity. Ceftolozane administered to rats during pregnancy and breast-feeding was associ

Who manufactures Zerbaxa?

Merck Sharp & Dohme B.V. (Francja)

What ATC class does Zerbaxa belong to?

Zerbaxa: ATC J01DI54. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Zerbaxa

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Zerbaxa — Description, Dosage, Side Effects | PillsCard

Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems, ATC code: J01DI54. Mechanism of action Ceftolozane belongs to the cephalosporin class of antimicrobials.‍‍‍‍‍‍‍ Ceftolozane exerts bactericidal activity through binding to important penicillin-binding proteins (PBPs), resulting in inhibition of bacterial cell-wall synthesis and subsequent cell death. Tazobactam is a beta-lactam structurally related to penicillins. It is an inhibitor of many molecular Class A beta-lactamases, including CTX-M, SHV, and TEM enzymes. See below. Mechanisms of resistance Mechanisms of bacterial resistance to ceftolozane/tazobactam include: i. Production of beta-lactamases that can hydrolyse ceftolozane and which are not inhibited by tazobactam (see below) ii. Modification of PBPs Tazobactam does not inhibit all Class A enzymes. In addition tazobactam does not inhibit the following types of beta-lactamase: i. AmpC enzymes (produced by Enterobacterales) ii. Serine-based carbapenemases (e.g., Klebsiella pneumoniae carbapenemases [KPCs]) iii. Metallo-beta-lactamases (e.g., New Delhi metallo-beta-lactamase [NDM]) iv. Ambler Class D beta-lactamases (OXA-carbapenemases) Pharmacokinetic/pharmacodynamic relationships For ceftolozane the time that the plasma concentration exceeds the minimum inhibitory concentration of ceftolozane for the infecting organism has been shown to be the best predictor of efficacy in animal models of infection. For tazobactam the PD index associated with efficacy was determined to be the percentage of the dose interval during which the plasma concentration of tazobactam exceeds a threshold value (%T > threshold). The time above a threshold concentration has been determined to be the parameter that best predicts the efficacy of tazobactam in in vitro and in vivo non-clinical models. Susceptibility testing breakpoints Minimum inhibitory concentration breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows: Minimum Inhibitory Concentrations (mg/L) Pathogen Type of Infection Susceptible Resistant Enterobacterales Complicated intra-abdominal infections* Complicated urinary tract infections* Acute pyelonephritis* Hospital-acquired pneumonia, including ventilator-associated pneumonia** ≤ 2 > 2 P. aeruginosa Complicated intra-abdominal infections* Complicated urinary tract infections* Acute pyelonephritis* Hospital-acquired pneumonia, including ventilator-associated pneumonia** ≤ 4 > 4 H. influenzae Hospital-acquired pneumonia, including ventilator-associated pneumonia** ≤ 0.5 > 0.5 *Based on 1 g ceftolozane / 0.5 g tazobactam intravenously every 8 hours. **Based on 2 g ceftolozane / 1 g tazobactam intravenously every 8 hours. Clinical efficacy against specific pathogens Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to Zerbaxa in vitro : Complicated intra-abdominal infections Gram-negative bacteria Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Gram-positive bacteria Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius Complicated urinary tract infections, including pyelonephritis Gram-negative bacteria Escherichia coli Klebsiella pneumoniae Proteus mirabilis Hospital-acquired pneumonia, including ventilator-associated pneumonia Gram-negative bacteria Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to Zerbaxa in the absence of acquired mechanisms of resistance: Citrobacter freundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Morganella morganii Proteus vulgaris Serratia liquefaciens In vitro data indicate that the following species are not susceptible to ceftolozane/tazobactam: Staphylococcus aureus Enterococcus faecalis Enterococcus faecium Paediatric population Zerbaxa was evaluated in two blinded, randomised, active-controlled clinical trials in paediatric patients from birth (defined as > 32 weeks gestational age and ≥ 7 days postnatal) to below 18 years of age, one in patients with complicated intra-abdominal infections (in combination with metronidazole), and the other in patients with complicated urinary tract infections and acute pyelonephritis. The primary objectives in these studies were to assess safety and tolerability of ceftolozane/tazobactam; efficacy was a secondary descriptive endpoint. Patients below 18 years of age with eGFR < 50 mL/min/1.73 m2 (estimated using Bedside Schwartz equation) were excluded from these clinical trials. Additionally, data in patients below 3 months of age with complicated intra‑abdominal infections are very limited (one patient in the Zerbaxa arm). Clinical cure rate at TOC (MITT) was 80.0% (56/70) for Zerbaxa compared to 100.0% (21/21) for meropenem in paediatric patients with complicated intra-abdominal infections. Microbiological eradication rate at TOC (mMITT) was 84.5% (60/71) for Zerbaxa compared to 87.5% (21/24) for meropenem in paediatric patients with acute pyelonephritis and complicated urinary tract infections. The European Medicines Agency has deferred the obligation to submit the results of studies with Zerbaxa in one or more subsets of the paediatric population in hospital-acquired pneumonia, including ventilator-associated pneumonia (see section 4.2 for information on paediatric use).

⚠️ Warnings

Each vial is for single use only. Aseptic technique must be followed in preparing the infusion solution. Preparation of doses The powder for concentrate for solution for infusion for each vial is reconstituted with 10 mL of water for injections or sodium chloride 9 mg/mL (0.9%) solution for injection per vial; following reconstitution the vial should be shaken gently to dissolve the powder.‍‍‍‍‍‍‍ The final volume is approximately 11.4 mL per vial. The resultant concentration is approximately 132 mg/mL (88 mg/mL of ceftolozane and 44 mg/mL of tazobactam) per vial. CAUTION: THE RECONSTITUTED SOLUTION IS NOT FOR DIRECT INJECTION. Zerbaxa solution for infusion is clear and colourless to slightly yellow. Variations in colour within this range do not affect the potency of the product. See section 4.2 for recommended dose regimens for Zerbaxa based on indication and renal function. The preparation for each dose is shown below. Instructions for preparing adult doses in INFUSION BAG: For preparation of the 2 g ceftolozane / 1 g tazobactam dose: Withdraw the entire contents from two reconstituted vials (approximately 11.4 mL per vial) using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection. For preparation of the 1.5 g ceftolozane / 0.75 g tazobactam dose: Withdraw the entire contents from one reconstituted vial (approximately 11.4 mL per vial) and 5.7 mL from a second reconstituted vial using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection. For preparation of the 1 g ceftolozane / 0.5 g tazobactam dose: Withdraw the entire contents (approximately 11.4 mL) of the reconstituted vial using a syringe and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection. For preparation of the 500 mg ceftolozane / 250 mg tazobactam dose: Withdraw 5.7 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection. For preparation of the 300 mg ceftolozane / 150 mg tazobactam dose: Withdraw 3.5 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection. For preparation of the 250 mg ceftolozane / 125 mg tazobactam dose: Withdraw 2.9 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection. For preparation of the 100 mg ceftolozane / 50 mg tazobactam dose: Withdraw 1.2 mL of the contents of the reconstituted vial and add it to an infusion bag containing 100 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection. Instructions for preparing paediatric doses in INFUSION BAG or in INFUSION SYRINGE: NOTE: The following procedure describes the steps to prepare 100 mL of stock solution with a final concentration of 10 mg/mL ceftolozane / 5 mg/mL tazobactam. The volume of this stock solution to be administered to the paediatric patient will be based on calculating the appropriate dose based on the patient's weight (see section 4.2). Detailed steps and calculations are provided. 1. Preparing the stock solution (100 mL of 10 mg/mL ceftolozane / 5 mg/mL tazobactam): Withdraw the entire contents (approximately 11.4 mL) of the reconstituted vial using a syringe and add it to an infusion bag containing 89 mL of 0.9% sodium chloride for injection (normal saline) or 5% glucose injection. 2. Preparing the required volume of stock solution for infusion: a. Calculate the appropriate amount of Zerbaxa (in mg) to deliver the required dose to the paediatric patient. Based on this dose in mg, calculate the appropriate volume of the 10 mg/mL ceftolozane / 5 mg/mL tazobactam stock solution to be administered. Refer to Table 5 below to confirm the calculations. Note that the table is NOT inclusive of all possible calculated doses but may be utilised to estimate the approximate volume to verify the calculation. b. Transfer an appropriately calculated volume of stock solution to an adequately sized infusion bag or infusion syringe. Values shown in Table 5 are approximate, and it may be necessary to round to the nearest graduation mark of an appropriately sized syringe for smaller volumes. Table 5: Preparation of Zerbaxa for paediatric patients (from birth* to below 18 years of age) from the 100 mL stock solution of 10 mg/mL ceftolozane / 5 mg/mL tazobactam Zerbaxa dose (mg/kg) Weight (kg) Calculated amount of ceftolozane (mg) Calculated amount of tazobactam (mg) Volume of stock solution to administer to patient (mL) 20 mg/kg ceftolozane / 10 mg/kg tazobactam** 50 and greater 1 000 500 100 40 800 400 80 30 600 300 60 20 400 200 40 15 300 150 30 10 200 100 20 5 100 50 10 3 60 30 6 1.5 30 15 3 *Defined as > 32 weeks gestational age and ≥ 7 days postnatal. **Children weighing > 50 kg and with eGFR > 50 mL/min/1.73 m 2 should not exceed the maximum dose of 1 g ceftolozane / 0.5 g tazobactam. One of the active ingredients, ceftolozane, may have harmful effects if it reaches the aquatic environment (see section 5.3). Do not throw away any unused medicinal product or waste material via wastewater. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. These measures will help protect the environment.

Zerbaxa

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