Ceftolozane-tazobactam

What is Ceftolozane-tazobactam?

• Ceftolozane-tazobactam (ZERBAXA) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor used for the treatment of complicated urinary tract infections and complicated intra-abdominal infections in adults.

Ceftolozan

What are the uses of this medicine?

ZERBAXA (ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated in patients 18 years or older for the treatment of the following infections caused by designated susceptible microorganisms:

• Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole
• Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis
• Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP)

• To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

How does this medicine work?

• Ceftolozane belongs to the cephalosporin class of antibacterial drugs.

The bactericidal action of ceftolozane results from inhibition of cell wall biosynthesis, and is mediated through binding to penicillin-binding proteins (PBPs). Ceftolozane is an inhibitor of PBPs of P. aeruginosa (e.g., PBP1b, PBP1c, and PBP3) and E. coli (e.g., PBP3).

• Tazobactam sodium has little clinically relevant in vitro activity against bacteria due to its reduced affinity to penicillin-binding proteins. It is an irreversible inhibitor of some beta-lactamases (e.g., certain penicillinases and cephalosporinases), and can bind covalently to some chromosomal and plasmid-mediated bacterial beta-lactamases.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with known serious hypersensitivity to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with ZERBAXA.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

Recommended Dosage:

• The recommended dosage of ZERBAXA for injection is 1.5 gram (g) (ceftolozane 1 g and tazobactam 0.5 g) for cIAI and cUTI and 3 g (ceftolozane 2 g and tazobactam 1 g) for HABP/VABP administered every 8 hours by intravenous infusion over 1 hour in patients 18 years or older and with a creatinine clearance (CrCl) greater than 50 mL/min.

Administration

• Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 1 hour in patients 18 years or older.
• ZERBAXA does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparing the infusion solution.
• Constitute each vial of ZERBAXA with 10 mL of sterile water for injection or 0.9% Sodium Chloride for Injection, USP and gently shake to dissolve.
• Inspect drug products visually for particulate matter and discoloration prior to use.
• ZERBAXA infusions range from clear, colorless solutions to solutions that are clear and slightly yellow. Variations in color within this range do not affect the potency of the product.
• Upon constitution with sterile water for injection or 0.9% sodium chloride injection, reconstituted ZERBAXA solution may be held for 1 hour prior to transfer and dilution in a suitable infusion bag.
• Following dilution of the solution with 0.9% sodium chloride or 5% dextrose, ZERBAXA is stable for 24 hours when stored at room temperature or 7 days when stored under refrigeration at 2 to 8°C (36 to 46°F). Discard unused portion.
• Constituted ZERBAXA solution or diluted ZERBAXA infusion should not be frozen.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• ZERBAXA 1.5 g (ceftolozane and tazobactam) for injection supplied as a sterile powder for reconstitution in single-dose vials containing ceftolozane 1 g (equivalent to 1.147 g ceftolozane sulfate) and tazobactam 0.5 g (equivalent to 0.537 g tazobactam sodium).

This medicine is available in fallowing brand namesː

• ZERBAXA

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• diarrhea
• headache
• pyrexia
• hepatic transaminases
• renal impairment/renal failure
• diarrhea

What special precautions should I follow?

• 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.
• 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.
• Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Evaluate if diarrhea occurs.

What to do in case of emergency/overdose?

Management of overdosage:

• In the event of overdose, discontinue ZERBAXA and provide general supportive treatment. ZERBAXA can be removed by hemodialysis.
• No information is available on the use of hemodialysis to treat overdosage.

Can this medicine be used in pregnancy?

• There are no data available on ZERBAXA, ceftolozane or tazobactam use in pregnant women to allow assessment of a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• ceftolozane sulfate
• tazobactam sodium

Inactive ingredients:

• Arginine
• sodium chloride
• anhydrous citric acid

Who manufactures and distributes this medicine?

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by: Steri-Pharma, LLC Syracuse, NY 13202, USA

What should I know about storage and disposal of this medication?

• ZERBAXA vials should be stored refrigerated at 2 to 8°C (36 to 46°F) and protected from light.
• The reconstituted solution, once diluted, may be stored for 24 hours at room temperature or for 7 days under refrigeration at 2 to 8° C (36 to 46°F).
• Discard unused portion.

• Dailymed label info on Ceftolozane-tazobactam
• FDA Ceftolozane-tazobactam

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