Pharmacy & Therapeutics - October 2008 - (Page 565)

DORIBAX™ (doripenem for injection) to their seriousness, although it is not possible to estimate their frequency and causality has not been established: Stevens Johnson Syndrome Toxic epidermal necrolysis Interstitial pneumonia Seizure DRUG INTERACTIONS Valproic Acid: A clinically significant reduction in serum valproic acid concentrations has been reported in patients receiving carbapenem antibiotics and may result in loss of seizure control. Although the mechanism of this interaction is not fully understood, data from in vitro and animal studies suggest that carbapenem antibiotics may inhibit valproic acid glucuronide hydrolysis. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations cannot be maintained in the therapeutic range or a seizure occurs. [see Warnings and Precautions] Probenecid: Probenecid interferes with the active tubular secretion of doripenem, resulting in increased plasma concentrations of doripenem. [see Clinical Pharmacology (12.3) in full Prescribing Information] Coadministration of probenecid with DORIBAXTM is not recommended. USE IN SPECIFIC POPULATIONS Pregnancy: Category B: Doripenem was not teratogenic and did not produce effects on ossification, developmental delays or fetal weight following intravenous administration during organogenesis at doses as high as 1 g/kg/day in rats and 50 mg/kg/day in rabbits (based on AUC, at least 2.4 and 0.8 times the exposure to humans dosed at 500 mg q8h, respectively). There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when DORIBAXTM is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Of the total number of subjects in clinical studies of DORIBAXTM, 28% were 65 and over, while 12% were 75 and over. Clinical cure rates in complicated intra-abdominal and complicated urinary tract infections were slightly lower in patients ≥65 years of age and also in the subgroup of patients ≥75 years of age versus patients <65. These results were similar between doripenem and comparator treatment groups. No overall differences in safety were observed between older and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Elderly subjects had greater doripenem exposure relative to non-elderly subjects; however, this increase in exposure was mainly attributed to agerelated changes in renal function. [see Clinical Pharmacology (12.3) in full Prescribing Information] This drug is known to be excreted substantially by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function or pre-renal azotemia. Because elderly patients are more likely to have decreased renal function or pre-renal azotemia, care should be taken in dose selection, and it may be useful to monitor renal function. Patients with Renal Impairment: Dosage adjustment is required in patients with moderately or severely impaired renal function. [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) in full Prescribing Information] In such patients, renal function should be monitored. 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 DORIBAXTM, 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. • Keep out of the reach of children. MINI-BAG Plus is a trademark of Baxter International Inc. Manufactured by: Shionogi & Co. Ltd. Osaka 541-0045, Japan January 2008 10157601B Distributed by: Ortho-McNeil Pharmaceutical, Inc. Raritan, NJ 08869 Statement of Ownership, Management, and Circulation 1) Publication Title: P&T: A Peer-Reviewed Journal for Managed Care and Hospital Formulary Management; 2) Publication Number: 1052-1372; 3) Filing Date: September 17, 2008; 4) Issue Frequency: Monthly; 5) Number of Issues Published Annually: 12; 6) Annual Subscription Price: $85.00; 7) Address of Known Office of Publication: MediMedia USA, Inc., 780 Township Line Road, Yardley, Pennsylvania 19067; 8) Address of Headquarters or General Business Office of Publisher: MediMedia USA, Inc., 780 Township Line Road, Yardley, Pennsylvania 19067; 9) Publisher: Timothy P. Search, R.Ph., MediMedia USA, 780 Township Line Road, Yardley, Pennsylvania 19067; Editor: Sonja Sherritze, MediMedia USA, 780 Township Line Road, Yardley, Pennsylvania 19067; Associate Editor: Carol Robins, MediMedia USA, 780 Township Line Road, Yardley, Pennsylvania 19067; 10) Owner: MediMedia USA, Inc., 780 Township Line Road, Yardley, Pennsylvania 19067; 11) Known Bondholders, Mortgagees, and Other Security Holders Owing or Holding 1 Percent or More of Total Amount of Bonds, Mortgages, or Other Securities: None; 12) Tax Status: Not applicable; 13) Publication Name: P&T: A Peer-Reviewed Journal for Managed Care and Hospital Formulary Management; 14) Issue date for circulation data below: August 2008; 15) Circulation: Average No. Copies Each Issue During Preceding 12 Months No. Copies Of Single Issue Published Nearest to Filing Date Extent and Nature Of Circulation a. Total number of copies (Net press run) b. Paid and/or requested distribution 1. Individual paid/requested mail subscriptions stated on PS Form 3541 2. Sales through dealers and carriers outside the USPS 3. Requested copies distributed by other mail classes c. Total paid and/or requested circulation d. Nonrequested distribution 1. Nonrequested copies stated on PS Form 3541 2. Nonrequested copies distributed by other mail classes 3. Nonrequested copies distributed outside the mail e. Total nonrequested distribution f. Total distribution g. Copies not distributed h. Total i. Percent paid and/or requested circulation 50,595 48,859 28,593 31,555 0 0 28,593 0 0 31,555 20,674 0 16,389 0 152 20,826 49,419 1,176 50,595 58% 150 16,539 48,094 765 48,859 66% I certify that all the above information is true and complete. Timothy P. Search, RPh Group Publisher Vol. 33 No. 10 • October 2008 • P&T® 565

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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