Pharmacy & Therapeutics - December 2008 - (Page 689)

NEW DRUGS is scheduled for January 12, 2009. (Sources: Associated Press, November 21, 2008; Teva, November 19, 2008.) DRUG NEWS features the Ikoniscope (a digital microscope) and provides automated testing of the HER-2 gene to provide an accurate indication for gene amplification. Purpose: The test offers laboratories and hospitals an economical method of automating FISH (fluorescence in situ hybridization) testing of patients with HER-2–positive breast cancer. The presence of HER-2 gene amplification indicates whether the patient is a candidate for therapy with trastuzumab (Herceptin, Genentech). HER-2 breast cancer is more aggressive than other types of breast cancer. HER-2 amplification occurs in 18% to 20% of breast cancers. Knowing the patient’s HER-2 status can help predict resistance to treatments. Benefit: This advance should help to standardize diagnostic testing and decrease waiting times for test results. Sources: www.pharmacyonesource. com; www.ikonisys.com/her2/her2_ Brochure.pdf; J Oncol Practice, 2007;3(1): 48–50 Name: CLARO Acne-Clearing Device Manufacturer: CLRS Technology, Costa Mesa, Calif. Approval Date: October 29, 2008 Use Classification: This device is used to treat mild-to-moderate inflammatory acne. Description: This is the first handheld apparatus to use intense pulsed light for patients with acne. Purpose: A series of light pulses, delivered in six seconds, safely penetrates the skin to eliminate the bacteria that cause acne and to reduce inflammation. Clinical studies demonstrated a 94.8% decrease in Propionibacterium acnes bacteria after just one treatment. Benefit: Pulsed light technology combines heat and light to clear acne rapidly. Sources: www.pharmacyonesource. com; www.clrstechnology.com; www. emaxhealth.com continued on page 694 Vol. 33 No. 12 • December 2008 • NEW INDICATIONS Dexmedetomidine (Precedex) For Sedation Dexmedetomidine HCl (Precedex, Hospira) was originally approved for the sedation of intubated and mechanically ventilated patients in intensive-care units (ICUs) for up to 24 hours. The new approval is indicated for non-intubated patients needing sedation before or during surgery and was based on the results of two randomized studies: MAC (Monitored Anesthesia Care) and AWAKE. This relatively selective alpha2-adrenoceptor agonist can be used before, during, and after extubation. (Source: Hospira, October 30, 2008.) drome, and with growth failure from inadequate secretion of endogenous GH. This product is also indicated for replacing GH in adults with GH deficiency of adult onset or of childhood onset. Source: Novo Nordisk, November 4, 2008.) Insulin Glulisine (Apidra) For Diabetic Children Sanofi-Aventis has received approval of insulin glulisine [rDNA origin] injection (Apidra) to improve glycemic control in children and adolescents four years of age and older with diabetes mellitus. The approval was based on the FDA’s review that compared insulin lispro (Humalog, Eli Lilly) in 572 children and adolescents with type-1 diabetes. No notewor thy dif ferences existed between treated groups in the number of patients reporting hypoglycemia. Hypoglycemia occurred in 7.2% of the glulisine patients and in 8.1% of the lispro patients. Insulin glulisine can be given by an infusion pump, a vial, a syringe, the OptiClik reusable insulin pen, or intravenously. This agent helps to lower glycosylated hemoglobin (HbA1c) levels in adults and in children four years of age and older with type-1 diabetes and in adults with type-2 diabetes. (Source: Sanofi-Aventis, October 29, 2008.) Growth Hormone (Norditropin) to Help SmallFor-Gestational-Age Children Children who are born with a condition that can prevent them from growing to a normal height now have a treatment option with Norditropin (somatropin [rDNA origin] injection). The drug treats short stature in small-for-gestational-age children whose growth has not caught up by the time they are two to four years of age. In a 13-year trial, 63% of the treated children who reached adult height were in the normal range of their peers. Each year, approximately 100,000 infants in the U.S. are born weighing less than 97% of all other babies of the same gestational age. These children may be at increased risk for obesity, insulin resistance, carbohydrate intolerance, dyslipidemia, and psychosocial disadvantages. Norditropin injection is also indicated for children with short stature associated with Noonan syndrome, with short stature associated with Turner syn- NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name: OncoFISH Her2 Test Manufacturer: Ikonisys, New Haven, Conn. Approval Date: October 28, 2008 Use Classification: This automated test can determine HER-2 (human epidermal growth factor-2) status in human breast cancer specimens that are processed with Abbott’s PathVysion HER2 DNA Probe Kit. Description: The CellOptics platform P&T® 689 http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.ikonisys.com/her2/her2_Brochure.pdf http://www.ikonisys.com/her2/her2_Brochure.pdf http://www.pharmacyonesource.com http://www.clrstechnology.com http://www.emaxhealth.com http://www.pharmacyonesource.com http://www.emaxhealth.com

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Pharmacy & Therapeutics - December 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Interpreting Estimates of Treatment Effects Chemotherapy Foundation Symposium XXVI: Innovative Cancer Therapy for Tomorrow Third Annual Onmark National Payor/Provider Forum Fourth Annual Ophthalmic Drug Development and Delivery Summit Classification and Pharmacological Management Of Obesity CE Test and Forms Season’s Greetings: Thanks to Our Readers and Reviewers

Pharmacy & Therapeutics - December 2008

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