To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Innohep (Tinzaparin) Low Molecular Weight Heparin, Now Available In US URL: http://www.pslgroup.com/dg/1E7A9E.htm Doctor's Guide October 23, 2000
WILMINGTON, DE -- October 23, 2000 -- DuPont Pharmaceuticals Company announced the U.S. market availability of its new once-daily low molecular weight heparin Innohep® (tinzaparin sodium injection) at the Annual Meeting of the American College of Chest Physicians in San Francisco. Approved by the U.S. Food and Drug Administration (FDA) in July, Innohep is indicated for the treatment of acute symptomatic deep vein thrombosis (DVT) with or without pulmonary embolism when administered in conjunction with warfarin sodium. The safety and effectiveness of Innohep were established in hospitalized patients. Warfarin is an oral anticoagulant manufactured and also sold by DuPont Pharmaceuticals Company under the brand name Coumadin® (warfarin sodium tablets, USP) Crystalline. DVT, a blood clot that develops most commonly in one of the major veins in the leg which can inhibit or block blood flow, is an underdiagnosed yet potentially life-threatening condition which affects up to five percent of U.S. adults. Acute DVT alone accounts for almost 800,000 hospitalizations each year. DVT often results in pulmonary embolism (PE), which occurs when one or more parts of a clot in the leg break loose and travel to the lungs, where the clot can lodge in a pulmonary artery. Routine autopsies find PE to be a major contributory factor in 10 to 15 percent of all hospital deaths. "The launch of Innohep provides U.S. healthcare professionals and patients alike with an important new treatment option for deep vein thrombosis; one that is supported by the expertise and leadership of a company with more than 40 years of experience in the antithrombotics market," said Nicholas L. Teti, president and chief executive officer of DuPont Pharmaceuticals Company. "Innohep represents yet another example of our commitment to grow DuPont Pharmaceuticals, both through product development and targeted business alliances." In addition to obtaining the U.S. marketing rights for Innohep from the Danish firm Leo Pharmaceutical Products in 1998, DuPont Pharmaceuticals announced an alliance with Kos Pharmaceuticals in May 2000 for the future development and commercialization of a drug containing extended-release niacin and lovastatin for the treatment of abnormal lipid levels. Kos filed a New Drug Application for this product with the FDA in September. The most common symptoms of DVT include pain and sudden swelling in the leg, enlargement of the superficial veins, and reddish-blue discoloration or skin that's warm to the touch. Pain that is often associated with DVT usually occurs in the calf or behind the knee, and may get worse upon standing or walking. Patients who experience any of these signs or symptoms should consult their physician immediately. People who have recently undergone surgery, those who are immobile for a prolonged period, cancer patients, and those with heart disease or diabetes are among the many who suffer from DVT. "In recent years, the treatment of DVT has been transformed by low molecular weight heparins like Innohep," stated Dr. Russell D. Hull, principal investigator for one of the pivotal clinical trials for Innohep, and professor of medicine and director of the Thrombosis Research Unit at the University of Calgary. "The added convenience of once-daily dosing with Innohep makes it a viable treatment alternative to traditional unfractionated heparin." DuPont Pharmaceuticals is offering an Innohep patient assistance program to ensure access to the product for eligible patients who are economically disadvantaged. In controlled clinical trials, including a landmark study published in the New England Journal of Medicine that enrolled 435 hospitalized patients with symptomatic proximal DVT (six percent had coexistent symptomatic PE), Innohep was shown to be as effective as standard heparin therapy in the treatment of DVT with or without PE. Total recurrent thromboembolic events (DVTs and PEs) occurred in six of 216 patients (2.8 percent) in the Innohep treatment arm and 15 of 219 patients (6.8 percent) in the intravenous (I.V.) heparin treatment arm. The 95 percent confidence interval for the total thromboembolic event rate difference (4.0 percent) was 0.07 percent, 8.07 percent. This difference was not statistically significant. Mortality with Innohep was 4.6 percent (10 patients) and with heparin 9.6 percent (21 patients). The 95 percent confidence interval for the mortality difference was 0.16 percent, 9.76 percent. Importantly, clinical studies in the treatment of DVT with or without PE also demonstrated a low incidence of bleeding (0.8 percent of 519 patients treated with subcutaneous Innohep as compared to 2.7 percent of 524 patients treated with intravenous heparin). The safety and efficacy of Innohep have been consistently demonstrated in clinical experience involving more than five million patients in over 20 countries worldwide. Spinal or epidural hematomas can occur with the associated use of low molecular weight heparins and spinal/epidural anesthesia or spinal puncture, which can result in long-term or permanent paralysis. The risk of hematomas is increased by the use of postoperative indwelling epidural catheters or by the concomitant use of drugs affecting hemostasis such as NSAIDs, platelet inhibitors or other anticoagulants. Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Please see Full Prescribing Information. Patients with active major bleeding, patients with (or a history of) heparin-induced thrombocytopenia, or patients with known sensitivity to heparin, tinzaparin sodium injection (or any of its constituents) or pork products should not be treated with Innohep. Innohep should be used with extreme caution in conditions with increased risk of hemorrhage. Bleeding is the most common adverse event associated with Innohep and can occur at any site. The most common adverse events in controlled clinical trials with Innohep were injection site hematomas (16 percent), abnormal elevations of AST (8.8 percent) and ALT (13 percent), urinary tract infection (3.7 percent), pulmonary embolism (2.3 percent) and chest pain (2.3 percent). Other bleeding events associated with Innohep at a frequency of greater than or equal to 1 percent were epistaxis (1.9 percent), hemorrhage (1.5 percent), hematuria (1.0 percent) and thrombocytopenia (1 percent). Innohep cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units and dosage. Each of these medications has its own instructions for use. Please see Full Prescribing Information for Innohep. The most common adverse event and serious risk of oral anticoagulation therapy with Coumadin is bleeding in any tissue or organ. Please see Full Prescribing Information for Coumadin. Related Links: Innohep (tinzaparin sodium injection) and DuPont Pharmaceuticals Company. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.