Pharmacy & Therapeutics - October 2008 - (Page PP1) PRODUCT PROFILER Sancuso® (Granisetron Transdermal Delivery System) A New Formulation for Chemotherapy-Induced Nausea and Vomiting INTRODUCTION 2 Classification 2 Medical Complications 2 Effect on Quality of Life and Costs 3 Goals of Therapy 4 INCIDENCE AND SEVERITY OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING IN CANCER TREATMENT 5 CURRENT DRUG THERAPY OPTIONS AND TREATMENT GUIDELINES 6 Pathophysiology 6 Pharmacotherapy 7 Treatment Guidelines 7 Acute Chemotherapy-Induced Nausea and Vomiting 7 Delayed Chemotherapy-Induced Nausea and Vomiting 7 Rationale for Transdermal Delivery 7 CHEMISTRY AND PHARMACOKINETICS 9 Chemical and Physical Properties 9 Mechanism of Action and Clinical Pharmacology 9 Pharmacokinetics and Drug Metabolism 9 Absorption 9 Distribution 9 Metabolism and Excretion 9 CLINICAL TRIALS 10 Study 392MD/4/C: A Phase 1 Pharmacokinetics/Safety/Patch Adhesiveness Study 10 Study 392MD/11C: A Phase 1 Study of Bioavailability, Dose, Proportionality, Local Tolerance, Safety, Tolerability, and Adhesion 11 Study 392MD/26/C: A Phase 1 Skin Irritation and Sensitization Study 14 Study 392MD/8/C: A Phase 2 Study Assessing the Safety, Efficacy, and Tolerability of the Granisetron Transdermal Delivery System in Comparison with Oral Granisetron in ChemotherapyInduced Nausea and Vomiting Following a Single-Day Administration of Moderately Emetogenic Chemotherapy 17 Study 392MD/15/C: A Phase 3 Non-inferiority Study Comparing the Efficacy of the Granisetron Transdermal Delivery System to Oral Granisetron with Regard to Complete Control of Moderately or Highly Emetogenic Multiday Chemotherapy 21 P&T COMMITTEE CONSIDERATIONS 24 Efficacy 24 Safety 24 How Supplied 25 CONCLUSION 26 REFERENCES 27 RESOURCES 27 PRESCRIBING INFORMATION 28 This section of P&T is supported by ProStrakan, Inc.
Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - October 2008 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 Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page Cover1) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page Welcome) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 555) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 556) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 557) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 558) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 559) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 560) Pharmacy & Therapeutics - October 2008 - Pharmacy & Therapeutics - October 2008 (Page 561) Pharmacy & Therapeutics - October 2008 - Contents (Page 562) Pharmacy & Therapeutics - October 2008 - Contents (Page 563) Pharmacy & Therapeutics - October 2008 - Contents (Page 564) Pharmacy & Therapeutics - October 2008 - Contents (Page 565) Pharmacy & Therapeutics - October 2008 - Editorial (Page 566) Pharmacy & Therapeutics - October 2008 - Medication Errors (Page 567) Pharmacy & Therapeutics - October 2008 - Medication Errors (Page 568) Pharmacy & Therapeutics - October 2008 - Prescription: Washington (Page 569) Pharmacy & Therapeutics - October 2008 - New Drugs/Drug News/ New Medical Devices (Page 570) Pharmacy & Therapeutics - October 2008 - New Drugs/Drug News/ New Medical Devices (Page 571) Pharmacy & Therapeutics - October 2008 - New Drugs/Drug News/ New Medical Devices (Page 572) Pharmacy & Therapeutics - October 2008 - New Drugs/Drug News/ New Medical Devices (Page 573) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 574) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 575) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 576) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 577) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 578) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 579) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 580) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 581) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 582) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 583) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 584) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 585) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 586) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 587) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 588) Pharmacy & Therapeutics - October 2008 - Drug Forecast (Page 589) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 590) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 591) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 592) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 593) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 594) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 595) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 596) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 597) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 598) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 599) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 600) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 601) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 602) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 603) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 604) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 605) Pharmacy & Therapeutics - October 2008 - Medical Management of Parkinson’s Disease (Page 606) Pharmacy & Therapeutics - October 2008 - Why Is Health Care Regulation So Complex? (Page 607) Pharmacy & Therapeutics - October 2008 - Why Is Health Care Regulation So Complex? (Page 608) Pharmacy & Therapeutics - October 2008 - The Next President’s Prescription for Action on Drugs (Page 609) Pharmacy & Therapeutics - October 2008 - The Next President’s Prescription for Action on Drugs (Page 610) Pharmacy & Therapeutics - October 2008 - Trends in Managing Multiple Sclerosis (Page 611) Pharmacy & Therapeutics - October 2008 - Trends in Managing Multiple Sclerosis (Page 612) Pharmacy & Therapeutics - October 2008 - Trends in Managing Multiple Sclerosis (Page 613) Pharmacy & Therapeutics - October 2008 - Trends in Managing Multiple Sclerosis (Page 614) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PPCover1) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PPCover2) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP1) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP2) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP3) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP4) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP5) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP6) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP7) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP8) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP9) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP10) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP11) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP12) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP13) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP14) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP15) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP16) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP17) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP18) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP19) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP20) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP21) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP22) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP23) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP24) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP25) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP26) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP27) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP28) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page PP29) Pharmacy & Therapeutics - October 2008 - Product Profiler: Sancuso® (Page Cover4)
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