Doribax: Package Insert and Label Information (Page 4 of 4)

14.2 Complicated Urinary Tract Infections, Including Pyelonephritis

A total of 1171 adults with complicated urinary tract infections, including pyelonephritis (49 percent of microbiologically evaluable patients) were randomized and received study medications in two multi-center, multinational studies. Complicated pyelonephritis, i.e., pyelonephritis associated with predisposing anatomical or functional abnormality, comprised 17% of patients with pyelonephritis. One study was double-blind and compared DORIBAX® (500 mg administered over 1 hour every 8 hours) to IV levofloxacin (250 mg admininstered every 24 hours). The second study was a non-comparative study but of otherwise similar design. Both studies permitted the option of switching to oral levofloxacin (250 mg administered every 24 hours) after a minimum of 3 days of IV therapy for a total of 10 days of treatment. Patients with confirmed concurrent bacteremia were allowed to receive 500 mg of IV levofloxacin (either IV or oral as appropriate) for a total of 10 to 14 days of treatment.

DORIBAX® was non-inferior to levofloxacin with regard to the microbiological eradication rates in microbiologically evaluable (ME) patients, i.e., patients with baseline uropathogens isolated, no major protocol deviations and urine cultures at test of cure (TOC) visit 5–11 days after completing therapy. DORIBAX® was also non-inferior to levofloxacin in microbiological modified intent-to-treat (mMITT) patients, i.e., patients with pretreatment urine cultures. Overall microbiological eradication rates at TOC and the 95% CIs for the comparative study are displayed in Table 10. Microbiological eradication rates at TOC by pathogen in ME patients are presented in Table 11.

Table 10. Microbiological Eradication Rates from the Phase 3 Comparative Study of Adults with Complicated Urinary Tract Infections, Including Pyelonephritis
Analysis populations DORIBAX® *n/N (%) Levofloxacin n/N (%) Treatment Difference(2-sided 95% CI §)
*
500 mg administered over 1 hour every 8 hours
n = number of patients in the designated population who were cured; N = number of patients in the designated population
250 mg administered intravenously every 24 hours
§
CI= confidence interval
ME = microbiologically evaluable patients
#
mMITT = microbiological modified intent-to-treat patients
ME 230/280 (82.1) 221/265 (83.4) -1.3 (-8.0, 5.5)
mMITT # 259/327 (79.2) 251/321 (78.2) 1.0 (-5.6, 7.6)
Table 11. Microbiological Eradication Rates By Infecting Pathogen in Microbiologically Evaluable Adults with Complicated Urinary Tract Infections, Including Pyelonephritis
Pathogen DORIBAX® * Levofloxacin
N n % N n %
*
data from comparative and non-comparative studies
N = number of unique baseline isolates
n = number of pathogens with a favorable outcome (eradication)
Gram-negative, aerobic
Escherichia coli 357 313 87.7 211 184 87.2
Klebsiella pneumoniae 33 26 78.8 8 5 62.5
Proteus mirabilis 30 22 73.3 15 13 86.7
Non-fermenters 38 27 71.1 8 5 62.5
Acinetobacter baumannii 10 8 80.0 1 0 0.0
Pseudomonas aeruginosa 27 19 70.4 7 5 71.4

15 REFERENCES

  1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – 7th ed. CLSI Document M7-A7. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2006.
  2. CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard – 9th ed. CLSI Document M2-A9. CLSI, Wayne, PA 19087, 2006.
  3. CLSI. Performance Standards for Antimicrobial Susceptibility Testing; 17th Informational Supplement. CLSI document M100-S17. CLSI, Wayne, PA 19087, 2007.
  4. CLSI. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard – 7th ed. CLSI document M11-A7. CLSI, Wayne, PA 19087, 2007.

16 HOW SUPPLIED/STORAGE AND HANDLING

DORIBAX® is supplied as single use type 1 clear glass vials containing 250 mg or 500 mg (on an anhydrous basis) of sterile doripenem powder. Vials are packaged individually and in cartons containing 10 vials:

  • NDC: 50458-401-01 – 500 mg/vial, single vial
  • NDC: 50458-401-02 – 500 mg/vial, 10 vials/carton
  • NDC: 50458-402-01 – 250 mg/vial, single vial
  • NDC: 50458-402-02 – 250 mg/vial, 10 vials/carton

Storage of DORIBAX® vials

DORIBAX® should be stored at 25°C (77°F); excursions permitted to 15°–30°C (59° to 86°F) [refer to USP controlled room temperature].

17 PATIENT COUNSELING INFORMATION

  • Patients should be advised that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. They should report any previous hypersensitivity reactions to DORIBAX® , other carbapenems, beta-lactams or other allergens.
  • Patients should be counseled that anti-bacterial drugs including DORIBAX® should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When DORIBAX® is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by DORIBAX® or other antibacterial drugs in the future.
  • Patients should be counseled to inform their physician
    • if they have central nervous system disorders such as stroke or history of seizures. Seizures have been reported during treatment with DORIBAX® and with closely related antibiotics
    • if they are taking valproic acid or sodium valproate. Valproic acid concentrations in the blood will drop below the therapeutic range upon co-administration with DORIBAX®. If treatment with DORIBAX® is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed.
  • Keep out of the reach of children.

MINI-BAG Plus is a trademark of Baxter International Inc.

Product of Japan

Manufactured by:
Shionogi & Co. Ltd.
Osaka 541-0045, Japan

Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560

© Janssen Pharmaceuticals, Inc. 2007

PRINCIPAL DISPLAY PANEL — 250 mg Carton

Contains 10 vials

DORIBAX®
(doripenem for injection)

250 mg/vial
Single Use Vial.
Discard any unused portion.
For Intravenous Infusion

Rx only

NDC 50458-402-02

Product should be stored
at 25°C (77°F); excursions
permitted to 15-30°C (59-86°F).

Keep out of the reach of children.

Product of Japan

Manufactured by:
Shionogi & Co. Ltd.
Osaka 541-0045,
Japan

Manufactured for:
Janssen
Pharmaceuticals, Inc.Titusville, NJ 08560

PRINCIPAL DISPLAY PANEL -- 250 mg Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mg Carton

Contains 10 vials

DORIBAX®
(doripenem for injection)

500 mg/vial
Single Use Vial
Discard any unused portion.
For Intravenous Infusion

Rx only

NDC 50458-401-02

Product should be stored
at 25°C (77°F); excursions
permitted to 15-30°C (59-86°F).

Keep out of the reach of children.

Product of Japan

Manufactured by:
Shionogi & Co. Ltd.
Osaka 541-0045,
Japan

Manufactured for:
Janssen Pharmaceuticals, Inc.Titusville, NJ 08560

Principal Display Panel -- 500 mg Carton
(click image for full-size original)
DORIBAX doripenem powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-401
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
doripenem (doripenem) doripenem 500 mg in 10 mL
Product Characteristics
Color WHITE (white to slighly-yellowish off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-401-02 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (50458-401-01)
1 NDC:50458-401-01 10 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50458-401-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022106 10/12/2007
DORIBAX doripenem powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-402
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
doripenem (doripenem) doripenem 250 mg in 10 mL
Product Characteristics
Color WHITE (white to slighly-yellowish off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-402-02 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (50458-402-01)
1 NDC:50458-402-01 10 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (50458-402-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022106 10/15/2010
Labeler — Janssen Pharmaceuticals, Inc. (063137772)
Establishment
Name Address ID/FEI Operations
Shionogi & Co., Ltd. 695266858 MANUFACTURE (50458-401) (50458-402), API MANUFACTURE (50458-401) (50458-402)
Establishment
Name Address ID/FEI Operations
Shionogi Analysis Center Co., Ltd. 690849209 ANALYSIS (50458-401) (50458-402)
Establishment
Name Address ID/FEI Operations
Shionogi Analysis Center Co., Ltd. 695266890 ANALYSIS (50458-401) (50458-402)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica, NV 370005019 LABEL (50458-401) (50458-402)

Revised: 04/2013 Janssen Pharmaceuticals, Inc.

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