Product Guide for Pharmacy

Product Guide
for Pharmacy
Indications
ZERBAXA™ (ceftolozane/tazobactam) is indicated in adult patients for the
treatment of complicated urinary tract infections (cUTI), including pyelonephritis,
caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella
pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
ZERBAXA used in combination with metronidazole is indicated in adult patients for the treatment
of complicated intra-abdominal infections (cIAI) caused by the following Gram-negative and
Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca,
Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis,
Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.
Please see Important Safety Information on the following pages
and accompanying full Prescribing Information.
Description1
ZERBAXA is an antibacterial combination product consisting of the cephalosporin
antibacterial ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium
for intravenous (IV) administration.
Dosing1
ZERBAXA is indicated for patients 18 years or older. The duration of therapy (cUTI 7 days,
cIAI 4-14 daysa) should be guided by the severity and site of infection and the patient’s
clinical and bacteriological progress.
Dosage of ZERBAXA by Infection in Patients
with Creatinine Clearance (CrCl) >50 mL/min1
Infection
Dose
Frequency
Infusion time
a
Duration
of treatment
Complicated urinary tract infections, including pyelonephritis
1.5 g (1 g/0.5 g)
Every 8 hours
1 hour
7 days
Complicated intra-abdominal infectionsa
1.5 g (1 g/0.5 g)
Every 8 hours
1 hour
4 to 14 days
Used in conjunction with metronidazole 500 mg IV every 8 hours.
Patients with Renal Impairment1
Because ZERBAXA is eliminated primarily by the kidneys, a dosage adjustment is required
for patients whose CrCl is 50 mL/min or less, as shown below.
For patients with changing renal function, monitor CrCl at least daily and adjust the dosage
of ZERBAXA accordingly.1
Dosage of ZERBAXA in Patients with Renal Impairment1
Estimated CrCl (mL/min)b
Recommended dosage regimen for ZERBAXAc
30 to 50
Ceftolozane/tazobactam 750 mg (500 mg/250 mg) intravenously every 8 hours
15 to 29
Ceftolozane/tazobactam 375 mg (250 mg/125 mg) intravenously every 8 hours
End-stage renal disease (ESRD)
on hemodialysis (HD)
A single loading dose of ceftolozane/tazobactam 750 mg (500 mg/250 mg) followed
by a 150 mg (100 mg/50 mg) maintenance dose administered every 8 hours for the
remainder of the treatment period (on hemodialysis days, administer the dose at the
earliest possible time following completion of dialysis).
CrCl estimated using Cockcroft-Gault formula.
All doses of ZERBAXA are administered over 1 hour.
b
c
Please see Important Safety Information
on the following pages.
Preparation of Solutions1
ZERBAXA does not contain a bacteriostatic preservative. Aseptic technique must
be followed in preparing the infusion solution.
Preparation of Doses
Constitute the vial with 10 mL of sterile water for injection or 0.9% Sodium Chloride
for Injection, USP (normal saline) and gently shake to dissolve. The final volume is
approximately 11.4 mL.
CAUTION: THE CONSTITUTED SOLUTION IS NOT FOR DIRECT INJECTION.
Dose
1.5 g (1 g/0.5 g)
Volume to withdraw from vial
11.4 mL (entire contents)
750 mg (500 mg/250 mg)
5.7 mL
375 mg (250 mg/125 mg)
2.9 mL
150 mg (100 mg/50 mg)
1.2 mL
Inspect parenteral 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.
Please see Important Safety Information
on the following pages.
How ZERBAXA Is Supplied1
ZERBAXA for injection is supplied in single-use, 20 mL clear glass vials containing 1 g
ceftolozane (equivalent to 1.147 g of ceftolozane sulfate) and 0.5 g tazobactam (equivalent
to 0.537 g of tazobactam sodium) per vial, in a carton containing 10 vials.
Package Size and Dimensions
Item weight (ounces per vial)
13.2 oz
Sales package size (carton)
10 x (1) 1.5 g IV vial
Carton dimensions (L x H x W) (inches)
6 5/16" x 2 11/16" x 2 9/16"
Case quantity
10 cartons or 100 vials
Case dimensions (L x H x W) (inches)
Case weight (pounds/ounces)
Pallet quantity
Cases per pallet
13.5" x 6.4" x 6.8"
8 lbs 4 oz
90 cases or 9000 vials
90
Pallet dimensions (L x H x W) (inches)
48" x 43.4" x 40"
Dimensions (L x H x W) (inches) w/o pallet
48" x 38.4" x 40"
Storage and Stability1
ZERBAXA vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F) and protected from light.
Upon constitution with sterile water for injection or 0.9% sodium chloride (normal saline) for
injection, ZERBAXA solution in the vial 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°C to 8°C (36°F to 46°F).
Constituted ZERBAXA solution or diluted ZERBAXA
infusion should not be frozen.
Please see Important Safety Information
on the following pages.
Pricing
WAC price per vial
$83
WAC price per carton (10 vials)
WAC price per day
a
$830
$25-$249
Price varies based on the level of renal impairment of the patient.
WAC=wholesale acquisition cost
a
Indications and Important Safety Information
Indications
ZERBAXATM (ceftolozane/tazobactam) is indicated in adult patients for the treatment of complicated
urinary tract infections (cUTI), including pyelonephritis, caused by the following Gram-negative
microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas
aeruginosa.
ZERBAXA used in combination with metronidazole is indicated in adult patients for the treatment of
complicated intra-abdominal infections (cIAI) caused by the following Gram-negative and Gram-positive
microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae,
Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus,
Streptococcus constellatus, and Streptococcus salivarius.
Important Safety Information
•H
ypersensitivity: ZERBAXA is contraindicated in patients with known serious hypersensitivity to
ceftolozane/tazobactam, piperacillin/tazobactam, or other members of the beta-lactam class. Serious
and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving
beta-lactam antibacterials. Before initiating therapy with ZERBAXA, make careful inquiry about previous
hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. If an anaphylactic
reaction to ZERBAXA occurs, discontinue use and institute appropriate therapy.
•P
atients with renal impairment: Decreased efficacy has been observed in 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.
•C
lostridium difficile–associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has
been reported with nearly all systemic antibacterial agents, including ZERBAXA. 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, antibacterial use not directed against C. difficile should
be discontinued, if possible.
•D
evelopment of drug-resistant bacteria: Prescribing ZERBAXA in the absence of a proven or
strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases
the risk of the development of drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions for ZERBAXA
are nausea, diarrhea, headache, and pyrexia.
Ordering
ZERBAXA comes packaged as 1.5 g IV vials, with 10 vials to 1 carton.
The minimum quantity that you can order at any time is 1 carton.
Wholesaler
Order entry number
AmerisourceBergen
10146684
Cardinal Health
5045810
McKesson
3411725
H.D. Smith
484-9071
Morris & Dickson
031179
UPC for ZERBAXA
N3 67919-030-01 7
NDC for ZERBAXA IV vials (10-ct)
67919-030-01
ZERBAXA IS A DROP-SHIP ITEM
Please contact your wholesaler directly
for assistance with product orders.
Please see Important Safety Information and accompanying full Prescribing Information.
Learn more at www.ZERBAXA.com
Reference: 1. ZERBAXA Prescribing Information, Cubist Pharmaceuticals; Lexington, MA.
©2014 Cubist Pharmaceuticals
ZERBAXA is a trademark of Cubist Pharmaceuticals
www.ZERBAXA.com ZER-0049 December 2014