Drug Topics - October 22, 2007 - (Page H4)

4HSE DRUG TOPICS OCTOBER 22, 2007 www.drugtopics.com Clinical Practice Topical human thrombin helps arrest bleeding Heidi Belden, Pharm.D. he first human thrombin approved since 1954 will soon be available. Evithrom is from Omrix Biopharmaceuticals and Johnson & Johnson Wound Management. The Biological License Application was cleared by the Food & Drug Administration in late August. The topical thrombin is plasma-derived from human donors and has been given a regulatory nod as an aid to hemostasis “The approval of whenever oozing blood and minor bleeding from capillaries and Evithrom offers an small venules are accessible, and important additional control of bleeding by standard surgical techniques option for surgeons is ineffective or impracand their patients tical. Jesse L. Goodman, M.D., M.P.H., director to help control of the FDA’s Center for surgical bleeding.” Biologics Evaluation & Research, said, “The Jesse L. Goodman, M.D., M.P.H. approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding. Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma.” New Biologic T The immunogenicity of Evithrom was evaluated by testing for the development of antibodies to highly purified antigens. Findings showed none of the patients treated with Evithrom developed antibodies to human thrombin or human factor V/Va, an advantage that is likely to give Evithrom rapid market share gain, according to market analysts. The efficacy of the human thrombin was tested in a phase III prospective clinical trial that compared the product with bovine-derived thrombin at 22 medical centers in 305 patients who underwent elective cardiovascular, neurologic (spinal), or general surgical procedures. Achievement of primary and secondary end points occurred at similar rates with both products—hemostasis within 10 minutes of application and at six minutes of application, respectively. Thrombin is a protease that activates clotting by transforming fibrinogen into fibrin. Topical use only Evithrom was approved to be used alone or in combination with an absorbable gelatin sponge and is for topical use only. The amount of product necessary depends on the area of tissue to be treated and the method of application. In clinical studies, a dose of up to 10 ml was used in combination with an absorbable sponge. Prior to application, the target surface area should be sponged free of blood. The affected area should then be flooded with Evithrom, using a sterile syringe and a single-gauge needle. Subsequent sponging of the clot should be avoided to ensure that it remains securely in place. According to the prescribing information, Evithrom will be supplied as a frozen solution in 2-, 5-, or 20-ml vials. Each vial contains 800 to 1,200 IU/ml of topical human thrombin. The frozen product can be stored in the freezer for up to two years but must be thawed prior to use. Evithrom will thaw in the refrigerator within one day, and within one hour at room temperature. In addition, the 2-ml and 5-ml vials will thaw at a temperature of 37°C within 10 minutes. According to J&J Wound Management, the company will begin distribution of Evithrom in the fourth quarter. DT Direct competition Evithrom’s direct competition will be bovine-derived Thrombin-JMI, from King Pharmaceuticals. Unlike Evithrom, the Thrombin-JMI label includes a black box warning of potential abnormalities in hemostasis due to the formation of antibodies against the bovine thrombin and/or factor V. TIPS TO REMEMBER Evithrom Evithrom is for topical use only and should not be injected. Vials are for single use only. Frozen vials of Evithrom can be stored at -18°C or colder for up to two years. Unopened vials may be stored at between 2°C and 8°C for up to 30 days. Evithrom must be thawed prior to administration and has been shown to be stable at room temperature for 24 hours. Evithrom should not be used for treating severe or brisk arterial bleeding. http://www.drugtopics.com

Table of Contents Feed for the Digital Edition of Drug Topics - October 22, 2007

Drug Topics - October 22, 2007 Contents Latebreakers Legislative Victory Builds Momentum for Pharmacy Month Letters Health-System Edition R.Ph.s Brace for Payment Denial for Hospital-Acquired Conditions Topical Human Thrombin Helps Arrest Bleeding FDA Panels Fail to Set Target Levels for Renal Patients’ Hemoglobin Warning Letters Raise Patient Safety Concerns for Fentora Ending/Reversing Weight Gain Man Given Fatal Drug Overdose at Staten Island Hospital Pharmacists Playing More Important Role in Dialysis Treatment AHA President R.Ph.'s Here's How You Can Increase Your Value Premier Launches Comprehensive Quality Improvement Project FDA Approves Dexrazoxane for Treatment of Extravasation New Federal, State Reforms to Ease Disaster Relief Kinks 150 Years of American Pharmacy Ten Tips for MTM Success Independent Superstars: The Ones to Watch The New Dynamic Duo A Parkinson's Disease Primer Classified New Products Advertisers Index Viewpoint

Drug Topics - October 22, 2007

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