zerbaxa
Pharmaranks rates Zerbaxa 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Zerbaxa is a combination medicine containing Ceftolozane Sulfate and Tazobactam Sodium.
Ceftolozane Sulfate and Tazobactam Sodium · by Cubist Pharms LLC
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ceftolozane Sulfate and Tazobactam Sodium
- Form
- Injectable
- Strength
- Ceftolozane Sulfate EQ 1GM BASE/VIAL; Tazobactam Sodium EQ 0.5GM BASE/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Cubist Pharms LLC
- FDA application
- NDA206829
What is Zerbaxa?
From the FDA label:ZERBAXA (ceftolozane and tazobactam) is an antibacterial combination product consisting of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Ceftolozane sulfate is a semi-synthetic antibacterial drug of the beta-lactam class for parenteral administration. The chemical name of ceftolozane sulfate is 1 H -Pyrazolium, 5-amino-4-[[[(2-aminoethyl)amino]carbonyl]amino]-2-[[(6 R ,7 R )-7-[[(2 Z )-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methyl-,sulfate (1:1). The molecular formula is C 23 H 31 N 12 O 8 S 2 + ∙HSO 4 - and the molecular weight is 764.77. Figure 1: Chemical structure of ceftolozane sulfate Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10 H 11 N 4 NaO 5 S and the molecular weight is 322.3. Figure 2: Chemical structure of tazobactam sodium ZERBAXA 1.5 g (ceftolozane and tazobactam) for injection is a white to yellow sterile powder for reconstitution consisting of ceftolozane 1 g (equivalent to 1.147 g of ceftolozane sulfate) and tazobactam 0.5 g (equivalent to…
How to use
Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 1 hour in adult patients. ( 2.1 ) Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 1 hour in pediatric patients (at least 32 weeks gestational age) with cIAI or cUTI. ( 2.2 ) Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 2 hours in pediatric patients (at least 32 weeks gestational age) with HABP/VABP. ( 2.2 ) Recommended Dosage of ZERBAXA by Infection in Adult Patients ( 2.1 ) Infection Dose Duration of Treatment cIAI Used in conjunction with metronidazole 500 mg intravenously every 8 hours ZERBAXA 1.5 g Administer all doses of ZERBAXA intravenously every 8 hours over 1 hour Provides 1 g ceftolozane and 0.5 g tazobactam 4 to 14 days cUTI, Including Pyelonephritis ZERBAXA 1.5 g 7 days HABP/VABP ZERBAXA 3 g Provides 2 g ceftolozane and 1 g tazobactam 8 to 14 days Recommended Dosage of ZERBAXA by infection in Pediatric Patients (at least 32 weeks gestational age) ( 2.2 ) Infection Dose Duration of Treatment cIAI Used in conjunction with metronidazole. ZERBAXA 30 mg/kg Provides 20 mg/kg ceftolozane and 10 mg/kg tazobactam. Pediatric patients with cIAI or cUTI weighing greater than 50 kg should not exceed a maximum dose of 1.5 g. up to a maximum dose of 1.5 g Administer all doses of ZERBAXA intravenously every 8 hours over 1 hour in pediatric patients…
Side effects
The following serious reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity reactions [see Warnings and Precautions (5.2) ] Clostridioides difficile -associated diarrhea [see Warnings and Precautions (5.3) ] Adult cIAI, cUTI and HABP/VABP Patients : The most common adverse reactions in adult patients (≥5% in either the cIAI or cUTI indication) are nausea, diarrhea, headache, and pyrexia. ( 6.1 ) The most common adverse reactions (≥5% in the HABP/VABP indication) are increase in hepatic transaminases, renal impairment/renal failure, and diarrhea. ( 6.1 ) Pediatric cIAI, cUTI and HABP/VABP Patients: The most common adverse reactions in pediatric patients (≥7% in cIAI, cUTI, or HABP/VABP) are thrombocytosis, diarrhea, pyrexia, leukopenia, abdominal pain, vomiting, increased aspartate aminotransferase, increased alanine aminotransferase, and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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 to rates in the clinical trials of another drug and also may not reflect rates observed in practice. Adult Patients Complicated Intra-abdominal…
Warnings
Important safety information
Decreased efficacy was observed in a Phase 3 cIAI trial in a subgroup of patients with baseline CrCl of 30 to 50 mL/min. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly. ( 5.1 ) Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs. Exercise caution in patients with known hypersensitivity to beta-lactam antibacterial drugs. If an anaphylactic reaction to ZERBAXA occurs, discontinue the drug and institute appropriate therapy. ( 5.2 ) Clostridioides difficile -Associated Diarrhea (has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Evaluate if diarrhea occurs. ( 5.3 ) 5.1 Decreased Efficacy in Patients with Baseline Creatinine Clearance of 30 to 50 mL/min In a subgroup analysis of a Phase 3 cIAI trial of adult patients, clinical cure rates were lower in patients with baseline CrCl of 30 to 50 mL/min compared to those with CrCl greater than 50 mL/min (Table 6). The reduction in clinical cure rates was more marked in the ZERBAXA plus metronidazole arm compared to the meropenem arm. A similar trend was also seen in the cUTI trial. Monitor CrCl at least daily in patients with changing renal function and adjust the dosage of ZERBAXA accordingly [see Dosage and Administration (2.2) ] . Table 6: Clinical Cure Rates in a Phase 3 Trial of Adult cIAI Patients by Baseline Renal Function (MITT Population) Baseline Renal Function ZERBAXA plus Metronidazole n/N (%) Meropenem n/N (%) CrCl greater than 50 mL/min 312/366 (85.2) 355/404 (87.9) CrCl 30 to 50 mL/min 11/23 (47.8) 9/13 (69.2) 5.2 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with ZERBAXA, make careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactams. If this product is to be given to a patient with a cephalosporin, penicillin, or other beta-lactam allergy, exercise caution because cross sensitivity has been established. If an anaphylactic reaction to ZERBAXA occurs, discontinue the drug and institute appropriate therapy. 5.3 Clostridioides difficile -Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including ZERBAXA, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C . difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is confirmed, discontinue antibacterials not directed against C. difficile , if possible. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile , and institute surgical evaluation as clinically indicated. 5.4 Development of Drug-resistant Bacteria Prescribing ZERBAXA in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Who should not take Zerbaxa
ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class. ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class. ( 4 )
Overdose — what happens if you take too much
In the event of overdose, discontinue ZERBAXA and provide general supportive treatment. ZERBAXA can be removed by intermittent hemodialysis. Approximately 66% of ceftolozane, 56% of tazobactam, and 51% of the tazobactam metabolite M1 were removed by dialysis. No information is available on the use of intermittent hemodialysis to treat overdosage.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Zerbaxa rated?
- pharmaranks gives Zerbaxa a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Zerbaxa?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Zerbaxa. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Zerbaxa?
- Zerbaxa is marketed by Cubist Pharms LLC. You can see Cubist Pharms LLC's full profile, rating, and other products on pharmaranks.
- Is Zerbaxa a brand-name or generic drug?
- Zerbaxa is a brand-name product with the active ingredient Ceftolozane Sulfate and Tazobactam Sodium.
- Is Zerbaxa available over the counter?
- No. Zerbaxa is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Zerbaxa come in?
- Zerbaxa is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Zerbaxa FDA-registered?
- Zerbaxa is on record with the U.S. FDA under application number NDA206829. You can verify this on its official FDA label.
- Has Zerbaxa been recalled by the FDA?
- Yes. Zerbaxa has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Zerbaxa safe?
- There's no single safe-or-not verdict. pharmaranks gives Zerbaxa a recall-safety score of 70/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Zerbaxa?
- Zerbaxa's side effects are taken directly from its FDA label. From the label: The following serious reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity reactions [see Warnings and Precautions (5.2) ] Clostridioides difficile -associated diarrhea [see Warnings and Precautions (5.3) ] Adult cIAI,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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zerbaxa
70/100