Pharmacy & Therapeutics- July 2008 - (Page 390) NEW DRUGS Sources: www.pharmacyonesource. com; Medical News Today, February 28, 2008; www.medicalnewstoday.com Name: CellSearch Circulating Tumor Cell Kit Manufacturer: Immunicon Corporation, Huntingdon Valley, Pa. Approval Date: February 27, 2008 Use Classification: The kit is used as an aid in monitoring patients with metastatic prostate cancer. Description: A sample of the patient’s blood is processed to capture and count circulating tumor cells. Purpose: Evaluating the circulating tumor cell count during the treatment of metastatic disease allows assessment of the patient’s prognosis and predicts survival. Benefit: Oncologists must often wait several months before they can determine whether a treatment is beneficial. With this kit, physicians can assess changes in the circulating tumor cell count in three to five weeks rather than in eight to 12 weeks, the usual period required to complete imaging studies. The serial test results can help physicians assess disease progression and make more informed decisions earlier. Sources: www.pharmacyonesource. com; Medical News Today, March 3, 2008, www.medicalnewstoday.com. Name: InPlex Cystic Fibrosis Molecular Test Manufacturer: Third Wave Technologies, Inc., Madison, Wisc. Approval Date: March 14, 2008 Use Classification: This genotyping test identifies cystic fibrosis mutations in DNA samples from isolated human whole peripheral blood specimens. Description: Cystic fibrosis is a fatal genetic disease that affects more than 30,000 Americans. The test provides information to determine the carrier sta- DRUG NEWS Name: FreeStyle Navigator Continuous Glucose Monitoring System Manufacturer: Abbott Diabetes Care, Alameda, Calif. Approval Date: March 12, 2008 Use Classification: This system is used to record interstitial fluid glucose levels in diabetic patients. Description: A sensor reports glucose values continuously for up to 120 hours. The sensor is inserted in either the abdomen or the back of the upper arm. After a 10-hour start-up period, the system is calibrated with a fingerstick measurement taken by a built-in glucose meter. After calibration, the system provides glucose readings and updated information on trends for viewing. A built-in alarm can be programmed to alert patients when results fall below preset low and preset high levels; another alarm alerts users before their results reach preset levels. Purpose: With this monitoring system, patients (18 years of age and older) can continually record their interstitial fluid glucose levels to improve diabetes management. Traditional blood glucose tests must be performed before therapy is adjusted for diabetes management based on the results and alarms in the system. Benefit: This system provides realtime readings, graphs, trends, and alarms directly to patients. It can be used at home to aid patients in detecting episodes of hypoglycemia and hyperglycemia and in clinical settings to aid health care professionals in evaluating glucose control. The system is available only by prescription, and it can provide more information than that obtained by fingerstick measurements alone. Sources: FDA, www.fda.com; Abbott, www.abbottdiabetescare.com I tus of adults of reproductive age, serves as an aid in screening newborns, and confirms diagnostic results in newborns and children. The test delivers the accuracy of the company’s Invader chemistry in a microfluidic card, developed in collaboration with the 3M Company. Purpose: The test is used to identify cystic fibrosis mutations in DNA samples of patients. Benefit: Compared with DNA sequencing (the standard for genotype determination), the Inplex test achieved 100% agreement on samples positive for cystic fibrosis and 99.96% overall agreement. The InPlex CF card was sensitive and specific. Minimal hands-on time and training were required, and the data generated were easily decipherable. Source: www.pharmacyonesource. com; www.inplexcf.com. Name: Silk’n Manufacturer: Home Skinovations, Ltd., Yokneam, Israel Approval Date: March 24, 2008 Use Classification: Silk’n is indicated for the home-based removal of unwanted hair under the direction of a physician. Description: Silk’n has been clinically tested and physician-approved for removing hair safely and effectively in the privacy of the home. The unit is available only by prescription. Purpose: Unwanted hair is removed via a photothermal treatment. This device is designed to be used with guidance from a physician. Benefit: An average reduction of 50% in the hair count was monitored three months after three biweekly treatment sessions in a study in North America and Israel. No adverse effects were noted. Subjects were extremely satisfied with the device. Sources: www.pharmacyonesource. com; www.medgadget.com; www.silkn. com 390 P&T® • July 2008 • Vol. 33 No. 7 http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.medicalnewstoday.com http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.inplexcf.com http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.medicalnewstoday.com http://www.fda.com http://www.abbottdiabetescare.com http://www.pharmacyonesource.com http://www.medgadget.com http://www.silkn http://www.pharmacyonesource.com
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